Analyze & Realize ag

Numerous studies have established that prebiotic ingredients in foods and dietary supplements may play a role in supporting human health. Over the three decades that have passed since prebiotics were first defined as a concept, research has revealed a complex universe of prebiotic-induced changes to the human microbiota. There are strong indications of a direct link between these prebiotic-induced changes and specific health benefits. However, at the present time, the EU has not permitted use of the term ‘prebiotic’ in connection with an approved health claim. This paper is the outcome of a workshop organized on the 25th October 2023 by the European branch of the International Life Science Institute (ILSI). It provides an overview of the regulatory requirements for authorized health claims in the EU, key areas of prebiotic research, and findings to date in relation to prebiotics and digestive, immune, metabolic and cognitive health. Research gaps and documentation challenges are then explored and a roadmap proposed for achieving authorization of ‘prebiotic’ in the wording of future EU health claims.

White kidney bean (Phaseolus vulgaris L.) extracts can aid weight management by reducing calorie intake from complex carbohydrates through alpha-amylase inhibition. We examined the impact of a proprietary aqueous extract from whole dried white kidney beans standardized by its alpha-amylase inhibitor activity (Phase 2 white kidney bean extract (WKBE)) on weight management in subjects with overweight and moderate obesity. In a randomized, double-blind, placebo-controlled fashion, 81 participants completed the study and ingested either a high dose of Phase 2 (1000 mg, WKBE HIGH), a low dose (700 mg, WKBE LOW), or a matching placebo (microcrystalline cellulose, PLA) three times a day, 30 min before meals, for 12 weeks during a calorie restricted diet. In a dose-dependent manner, Phase 2 significantly reduced body weight, fat mass, BMI, waist, hip and in the WKBE HIGH group thigh circumference. Phase 2 is an effective and safe supplement aiding weight and fat loss. ClinicalTrials.gov identifier NCT02930668.

Cognitive impairment is a significant health issue for people aging with HIV/AIDS. With pharmacological treatment lacking, psychosocial group therapies may best help people aging with HIV who experience cognitive challenges cope with their symptoms. The COVID-19 pandemic revealed how in-person group therapies need adaptation for hybrid or online delivery. Peer-led focus groups discussed adapting cognitive remediation group therapy (CRGT) as a hybrid or online intervention. CRGT combines mindfulness-based stress reduction and brain training activities. Purposive sampling was used to recruit people aging with HIV (40+) who self-identified cognitive concerns and resided in one of two Canadian provinces. Thematic content analysis was employed on transcripts by seven independent coders. Ten, two-hour focus groups were conducted between August and November 2022. Participant (n=45) demographics included age (M=53.22, SD=7.62), gender (45% women, 42% men, 13% trans/non-binary), sexual orientation (42% gay, 40% heterosexual, 18% other), ethnicity (45% White, 33% Black, 13% Indigenous, 9% mixed-race), and employment (33% employed, 67% retired/disability), and all on treatment and retained in care. Overall, participants responded favourably to CRGT’s modalities. Alongside support for its continued implementation in-person, participants requested online synchronous and online asynchronous formats. Preferred intervention facilitators were peers and mental health professionals. We also discuss how to adapt psychosocial HIV therapies for technology-mediated delivery, with consideration for behavioral HIV research.

Cognitive impairment is a significant health issue for people aging with HIV/AIDS. Cognitive challenges can include forgetfulness, trouble concentrating, and increasing struggles to learn new skills, all of which contribute to poorer mental health and decreased quality of life. Although there is no specific drug therapy that can reverse the brain impairment, group therapies may help people aging with HIV and cognitive challenges to better cope with their symptoms when combined with their usual medical treatment and follow-up. This community-based study will involve peer-led focus groups to discuss cognitive remediation group therapy-a combination of mindfulness-based stress reduction and brain training activities tested in a pilot randomized, controlled trial-as an in-person intervention for people aging with HIV in 2019. Via a brief demographic survey and technology-mediated focus groups (n = 40) in Ontario and Saskatchewan, we will determine how the intervention could be adapted in an online or hybrid format considering the ongoing COVID-19 pandemic. Content analysis will be employed whereby a team of independent coders will code the focus group transcripts in line with the co-design framework and "Double Diamond" model of developing interventions, including intervention structure, content, and mode of delivery. Given the aging of the HIV population in Canada, increasing support will be required in addition to medical care to improve quality of life, and proactively address concerns about cognition. This protocol provides a roadmap for adapting in-person psychosocial interventions using community-based and technology-mediated methods.

Introduction: The population of people living with HIV (PLWH) is ageing consequent to effective treatment and a steady stream of new diagnoses among older adults. PLWH experience a greater burden of age-related comorbidities and poorer social determinants of health compared to their HIV-negative peers, yet comprehensive requisites for care and support as PLWH age remain poorly understood. Preferences And Needs for Ageing Care among HIV-positive Elderly people in Ontario, Canada (PANACHE ON), explored the health and community care and social support needs and preferences of a diverse group of older PLWH (age 60+) and described life course experiences among older PLWH that shape these needs and preferences and whether they are met. Methods: PANACHE ON was a qualitative community-based participatory research study. In-person focus groups using a semi-structured interview guide were co-facilitated by pairs of trained older PLWH from July to October 2019. Purposive sampling bolstered the inclusion of communities disproportionately affected by HIV in Ontario. Descriptive analysis was used to summarize demographic data; participatory data analysis was conducted by a subset of the research team, with transcripts double-coded and analysed using NVIVO 12 Plus. Results: A total of 73 PLWH participated, 66% identified as men. The mean age was 64 years (range 55-77) and median time living with HIV was 23 years (range 2-37). The current and anticipated needs of older PLWH, many of which were only partially met, included necessities such as food and housing, mobility and sensory aids, in-home support, social and emotional support, transportation and information. Three experiences-trauma, stigma and uncertainty-intersected in the lives of many of our participants, shaping their needs for care and support, and impacting the ease with which these needs were met. Conclusions: Unmet health and social needs and limited control over the availability and accessibility of ageing-related care and support due to resource constraints or reduced capacity for self-advocacy results in anxiety about the future among older PLWH, despite their well-developed coping strategies and experience navigating systems of care. These study findings will inform the development of the first national needs assessment of older PLWH in Canada.

Background: Probiotics may alleviate lactose maldigestion. Objectives: The objective was to select a probiotic with high lactase activity and compare it with lactase and placebo in clinical trials. Methods: Bacterial cultures were screened for lactase activity in a model of the upper gastrointestinal tract. Bifidobacterium lactis Bi-07 (Bi-07) counts were adjusted in subsequent experiments to correspond to 4500 Food Chemical Codex (FCC) units of lactase, the amount in the European Food Safety Authority (EFSA)-approved health claim. Two crossover clinical trials, Booster Alpha and Booster Omega, were performed in participants with lactose intolerance, where 2 × 1012 colony forming units (CFU) Bi-07, 4662 FCC lactase, or placebo was consumed simultaneously with a lactose challenge, with 1-week washouts between challenges. The trial designs were identical except for the source of lactose. Breath hydrogen concentration (BHC) was measured to assess the effect of the investigational products on lactose digestion, for which incremental area under the curve (iAUC) was the primary outcome. Peak BHC, cumulative BHC, and gastrointestinal symptoms were secondary outcomes. Results: Bi-07 was superior to placebo in reducing BHC (iAUC, parts per million (ppm)∙h) in both trials (Booster Alpha: geometric least square mean ratio 0.462 [95% confidence interval (CI):0.249, 0.859], P = 0.016; Booster Omega: 0.227 [95% CI:0.095, 0.543], P = 0.001). Lactase was superior to placebo in Booster Alpha (0.190 [95% CI:0.102, 0.365], P < 0.001) but not Booster Omega (0.493 [95% CI:0.210, 1.156], P = 0.102). Noninferiority of Bi-07 versus lactase was observed in Booster Omega (0.460 [95% CI:0.193, 1.096], P = 0.079, CI upper limit < 1.25 noninferiority margin). Odds of abdominal pain (vs placebo: 0.32, P = 0.036) and flatulence (vs placebo: 0.25, P = 0.007) were lower with lactase in Booster Alpha. Increased odds of nausea were seen with Bi-07 (vs placebo: 4.0, P = 0.005) in Booster Omega. Conclusions: Bi-07 has high lactase activity, and in 2 clinical trials, it supported lactose digestion in individuals with lactose intolerance. The clinical trials have been registered at Clinicaltrials.gov with the following identifiers: Booster Alpha: NCT03659747 (https://clinicaltrials.gov/ct2/show/NCT03659747?term=NCT03659747&draw=2&rank=1)Booster Omega: NCT03814668 (https://clinicaltrials.gov/ct2/show/NCT03814668?cond=NCT03814668&draw=2&rank=1).

Introduction: The aim of this study was to evaluate the benefit and tolerability of two dosages of a proprietary flaxseed mucilage (IQP-LU-104) in reducing body weight in overweight and moderately obese individuals. Methods: In a double-blind, randomized, placebo-controlled, bi-center trial, 108 participants (Body Mass Index (BMI) 25 to < 35 kg/m2) were randomly allocated to receive either IQP-LU-104 high dose (104HD), IQP-LU-104 low dose (104LD), or placebo. Participants were instructed to consume 1 sachet of the investigational product (containing IQP-LU-104 or matching placebo) before or with main meals twice daily and to follow a balanced but hypocaloric diet (20% reduction of individual's daily energy requirements) for 12 weeks. At week 0 (baseline), week 4, 8 and 12 of the intervention periods, the participants' body weight, BMI, body fat composition and waist and hip circumferences were measured. Blood samples were collected for safety assessment at screening visit (week -2) and at the end of the study. Adverse events were assessed by the investigators through interviewing the participants and were recorded at every visit post screening. Results: At the end of the 12-week study, body weight reduction was greater in the 104HD group (4.96 ± 1.89 kg, p < 0.001 vs. placebo) and 104LD group (3.70 ± 2.57 kg, p < 0.001 vs. placebo) compared to the placebo group (1.33 ± 2.05 kg). 68% and 46% of participants in the 104HD group (p < 0.001 vs. placebo) and 104LD group (p = 0.002 vs. placebo) respectively experienced at least 5% weight loss, compared to 9% of participants in the placebo group. Significant decreases in waist and hip circumferences were observed in both the 104HD and 104LD groups compared to the placebo group (each p < 0.001). 104HD group had significantly higher reduction in body fat mass (4.25 ± 5.86 kg) than the placebo group (1.06 ± 3.20 kg) (p = 0.002). Respiratory tract infections and gastrointestinal symptoms were the main adverse events reported and none of the adverse events were related to the intake of IQP-LU-104. Conclusion: Results demonstrated IQP-LU-104 is safe and efficacious in body weight reduction at both dosages in overweight and moderately obese individuals.

Background: Increasing evidence supports the role of the gut microbiota in the control of body weight and feeding behavior. Moreover, recent studies have reported that the probiotic strain Hafnia alvei HA4597® (HA), which produces the satietogenic peptide ClpB mimicking the effect of alpha-MSH, reduced weight gain and adiposity in rodent models of obesity. Methods: To investigate the clinical efficacy of HA, 236 overweight subjects were included, after written informed consent, in a 12-week prospective, double-blind, randomized study. All subjects received standardized counselling for a −20% hypocaloric diet and were asked to maintain their usual physical activity. Subjects of the HA group received two capsules per day providing 100 billion bacteria per day and subjects in the Placebo (P) group received two placebo capsules. The primary endpoint was the percentage of subjects achieving a weight loss of at least 3% after 12 weeks. Intention-to-treat statistical analysis was performed using exact-Fischer, Mann-Whitney and paired-Wilcoxon tests as appropriate. Results: In the HA group, significantly more subjects (+33%) met the primary endpoint than in the P group (54.9 vs. 41.4%, p = 0.048). In the HA group, an increased feeling of fullness (p = 0.009) and a greater loss of hip circumference (p < 0.001) at 12 weeks were also observed. Fasting glycemia at 12 weeks was significantly lower (p < 0.05) in the HA compared to P group. Clinical and biological tolerance was good in both groups. Conclusions: A 12-week treatment with the probiotic strain H. alvei HA4597® significantly improves weight loss, feeling of fullness and reduction of hip circumference in overweight subjects following moderate hypocaloric diet. These data support the use of H. alvei HA4597® in the global management of excess weight.

The prevalence of acute respiratory infections and their impact on quality of life underlies the need for efficacious solutions that are safe, sustainable and economically viable. Polysaccharides in several (traditional) plant extracts have been shown to be immunostimulatory, and some studies suggest beneficial effects against respiratory infections. The aim of this study was to (i) identify the active polysaccharide constituents from affordable and renewable crops (bell pepper and carrot) using activity-guided fractionation, (ii) evaluate in vitro effects on innate immune responses (phagocytosis and cytokine secretion), microbiota modulation and production of short chain fatty acids, followed by (iii) the evaluation of effects of a bell pepper extract enriched for the active component in a human proof of concept study. We identified rhamnogalacturonan-I (RG-I) as the nutricophore responsible for the immunostimulatory activity with substantial structural and functional equivalence between bell pepper (bp) and carrot (c). The in vitro studies showed that bpRG-I and cRG-I comprise similar immune- and microbiota modulatory potential and the human study demonstrated that bpRG-I was well tolerated and enhanced innate immune responsiveness in vivo. This is an important step towards testing the efficacy of RG-I from bpRG-I or cRG-I in an infection trial in humans.

Intense and prolonged exercise leads to immune suppression, causing upper respiratory tract infections (URTI). A proprietary standardized dietary supplement, IQP-AS-119 has been previously developed to aid immune responses under such conditions. The current randomized, double-blind, placebo-controlled pilot study aimed to investigate the effects of IQP-AS-119 on marathon runners. A total of 80 participants were randomized equally into groups receiving either placebo (P group) or IQP-AS-119 (V group) treatment, starting 3 weeks before and for 14 days after the marathon. Benefit assessment was performed using different questionnaires. Post-marathon, the V and P groups reported 1±2.38 and 2.11±3.25 days with upper respiratory tract symptoms (URTS), respectively (P=0.038). During the 14 days post-marathon, 20.0% of the participants in the V group compared with 44.4% in the P group reported URTS (P=0.042). The V group reported significantly milder URTS compared with the P group on Days 9, 12, 13 and 14 post-marathon (P<0.05). The total Perceived Stress Questionnaire-20 score on days 2-14 were significantly lower for the V group compared with the P group (P=0.035). In the Short Form 12 Health Survey, the V group exhibited significant improvement in mental composite score on days -5 to 14 compared with the P group (P=0.038). In the overall treatment effect assessment, there were no statistically significant differences between the groups. The IQP-AS-119 was rated 'very good' or 'good' by investigators and participants, respectively, for 71 and 65% of the participants. The tolerability of IQP-AS-119 was rated as 'very good' or 'good' by both investigators and 95% of participants. No clinically relevant differences were observed between groups regarding adverse events or other safety parameters. Therefore, IQP-AS-119 was demonstrated to reduce the incidence and severity of URTI in marathon runners. Given its good tolerability profile, IQP-AS-119 may be a good nutritional supplement for the reduction of URTS in susceptible individuals.

Background: People living with HIV are living longer, and can experience physical, mental and social health challenges associated with aging and multimorbidity. Rehabilitation is well positioned to address disability and maximize healthy aging. An international collaborative network, called the Canada-International HIV and Rehabilitation Research Collaborative (CIHRRC), works to guide this emerging field. In this article, we report findings from CIHRRC's aim to identify emerging research priorities in HIV, aging and rehabilitation from the perspectives of people living with HIV, clinicians, researchers, representatives from community organizations and policy stakeholders. Methods: We conducted a multi-stakeholder multi-method international consultation with people living with HIV, researchers, clinicians and representatives of community-based organizations to identify research priorities in HIV, aging and rehabilitation. Stakeholders identified research priorities during a one-day International Forum comprised of presentations and facilitated discussion. We collated and analyzed data using content analytical techniques, resulting in a framework of research priorities. Results: Sixty-nine stakeholders from countries including Canada (n = 62; 90%), the United Kingdom (n = 5; 7%), United States (n = 1; 1%) and Australia (n = 1; 1%) attended the International Forum on HIV, Aging and Rehabilitation Research. Stakeholders represented community-based organizations (n = 20; 29%), academic institutions (n = 18; 26%), community or institutional healthcare organizations (n = 11; 16%), research or knowledge production organizations (n = 10; 14%), and organizations representing government or industry (n = 10; 14%). The Framework of Research Priorities in HIV, Aging and Rehabilitation includes seven research priorities: (1) nature, extent and impact of disability, concurrent health conditions and chronic inflammation with HIV; (2) prevalence, severity and impact of frailty; (3) community and social participation aging with HIV; (4) strategies for chronic disease management and healthy aging with HIV; (5) facilitators and barriers to access and engagement in, rehabilitation; (6) effectiveness of rehabilitation interventions for healthy aging with HIV; and (7) advancing development and use of patient reported outcome measures in HIV and aging. The Framework highlights methodological considerations to approach the priorities and the importance of knowledge translation and exchange to apply research knowledge into practice, programs and policy. Conclusions: These priorities offer a foundation for collaboration among international and multidisciplinary teams to advance the field of HIV, aging and rehabilitation in order to promote healthy aging with HIV.

Trimethylamine-N-oxide (TMAO) is generated in a microbial-mammalian co-metabolic pathway mainly from the digestion of meat-containing food and dietary quaternary amines such as phosphatidylcholine, choline, betaine, or L-carnitine. Fish intake provides a direct significant source of TMAO. Human observational studies previously reported a positive relationship between plasma TMAO concentrations and cardiometabolic diseases. Discrepancies and inconsistencies of recent investigations and previous studies questioned the role of TMAO in these diseases. Several animal studies reported neutral or even beneficial effects of TMAO or its precursors in cardiovascular disease model systems, supporting the clinically proven beneficial effects of its precursor, L-carnitine, or a sea-food rich diet (naturally containing TMAO) on cardiometabolic health. In this review, we summarize recent preclinical and epidemiological evidence on the effects of TMAO, in order to shed some light on the role of TMAO in cardiometabolic diseases, particularly as related to the microbiome.

Cardiovascular diseases are the main cause of death in the industrialized world, with the main risk factors being elevated blood pressure and blood lipid levels, leading to arterial stiffness and arteriosclerosis. In this study, we examined the effect of aged garlic extract (AGE) on arterial elasticity, using the EndoPAT™ technology in subjects with slightly elevated blood pressure. This randomized double-blind, placebo-controlled clinical trial examined 57 subjects over a period of 12 weeks, with EndoPAT™ measurements taken at 0 and 12 weeks; in addition, changes in blood pressure were analyzed. The positive effect of AGE on blood pressure values previously reported was confirmed. The results revealed a significant decrease in blood pressure in the AGE group, and in particular diastolic blood pressure. Using the EndoPAT™ technology, the augmentation index (AI) was analyzed, which measures arterial stiffness calculated via pulse waveform analysis of the PAT signal; lower AI values reflect better arterial elasticity. The AGE group exhibited a significant improvement in arterial elasticity, measured as AI75, by 21.6%. The result of this well-controlled clinical trial confirmed the positive effect of AGE on blood pressure. To the best of our knowledge, for the first time, the effect of AGE on arterial elasticity could be proven using the EndoPAT™ methodology. These results not only demonstrate the positive effects of AGE on the relevant risk factors of cardiovascular diseases, but also the direct effect on arterial elasticity. These data clearly indicate that AGE may exert several positive direct effects on the development and progression of cardiovascular diseases.

The disaccharide and innovative ingredient cellobiose, consisting of two β-glucose molecules linked by a β(1→4) bond is the main component of cellulose. Cellobiose can be used within a wide variety of foodstuffs and functional foods as a low-caloric bulking agent or as a substitute for lactose. For purposes of industrial large-scale production, cellobiose is produced by an enzymatic reaction in which sucrose and glucose are converted to cellobiose and fructose. The goal of this single-arm, dose-escalation study was to evaluate the safety and tolerability of cellobiose and to determine the maximum tolerated dose of cellobiose in healthy subjects. Following a baseline period, consecutive cohorts of six subjects each consumed either single doses of 10, 15, 20 and 25 g, while 12 subjects each received multiple doses of 15 g or 20 g cellobiose (twice daily, 14 days). The main recorded parameters were stool consistency, gastrointestinal well-being (Gastrointestinal Symptom Rating Scale) and adverse events. In each highest single/multiple dosage group, some sensitive subjects experienced flatulence, borborygmus and/or transient diarrhoea. A 100% global tolerability rating makes 20 g cellobiose a tolerable dose for single use. For repeated consumption, we propose up to 15 g cellobiose twice daily (92.6% global tolerability rating). Cellobiose is a promising new ingredient with excellent tolerability.

[This corrects the article DOI: 10.1155/2019/3412952.].

This prospective, noninterventional, multicenter 12-wk study in women with overactive bladder investigated the effectiveness of Granu Fink femina, a herbal combination of seed oil from Uromedic pumpkin (cultivar of Cucurbita pepo), Rhus aromatica (fragrant sumach) bark extract, and Humulus lupulus (hop) cone extract in a clinical setting. Patients documented overactive bladder symptoms and quality of life using questionnaires as well as diaries recording day- and nighttime micturition frequencies, urine leakages during physical activity or at sneezing or coughing, and use of incontinence pads. The full analysis set included 117 women (age: 21 – 78 y). Urination frequency decreased significantly with improvement during daytime in 49, 71, and 77 (out of 99) patients and at night in 45, 63, and 70 (out of 100) patients after 1, 6, and 12 wk, respectively. The mean frequency of leakages and used pads decreased significantly from 0.9 leakages and 2.0 pads at baseline to 0.4 leakages and 1.4 pads after 12 wk. In all measured aspects of overactive bladder-related quality of life, (coping, concern, sleep, social), statistically significant improvement was reached after 1 wk, with further improvement at 6 and 12 wk. Ninety-nine percent of the physicians and 95.4% of the patients rated tolerability as “very good” or “good”. Treatment with Granu Fink femina progressively improved overactive bladder symptoms and related quality of life with significant improvements already after 1 wk. Based on these effects and the observed excellent tolerability profile, Granu Fink femina may be considered a valuable therapeutic option for overactive bladder.

Objective: The purpose of this study was to explore the clinical benefit and tolerability of IQP-AO-101 in healthy subjects with sleep complaints. Methods: This double-blind, randomized, placebo-controlled trial involved fifty subjects with sleep complaints. Subjects with a Pittsburgh Sleep Quality Index (PSQI) score between 6 and 15 were randomized to receive either IQP-AO-101 or placebo for 6 weeks, following a run-in period of one week. Sleep parameters were assessed at baseline and after 1, 4, and 6 weeks using the modified Athens Insomnia Scale (mAIS). Subjects were also instructed to wear an activity tracker and keep a sleep diary during the study. Other questionnaires administered were the Frankfurt Attention Inventory (FAIR-2) and the Profile of Mood States (POMS-65). Blood samples for safety laboratory parameters were taken before and at the end of the study. Results: After 6 weeks, subjects who consumed IQP-AO-101 reported significant improvements in mAIS scores compared with placebo, including mAIS total score (11.76 ± 6.85 vs 4.00 ± 4.80; p < 0.001); night parameters composite score (5.20 ± 3.80 vs 2.04 ± 3.16; p = 0.001); and day parameters composite score (6.56 ± 4.10 vs 1.96 ± 2.65; p < 0.001). All individual parameters (Items 1 to 8) were also significantly improved from baseline after 6 weeks of IQP-AO-101 intake. Analysis of variance with baseline values as covariates showed statistically significant improvements across all individual parameters for IQP-AO-101 when compared to placebo. The measurements using the activity tracker, sleep diary, FAIR-2, and POMS did not reveal any significant differences between groups. No adverse effects related to the intake of IQP-AO-101 were reported. Tolerability was rated as very good by all the subjects and by the investigator for all cases. Conclusions: In this study, IQP-AO-101 was well tolerated and efficacious for promoting sleep and enhancing daytime performance in subjects with moderate sleep disturbances. Clinical trial registration: This trial is registered with ClinicalTrials.gov, no. NCT03114696.

Objective: This study was performed to determine the efficacy and tolerability/safety of IQP-AE-103 on body weight reduction in overweight to moderately obese adults. Methods: A double-blind, randomized, placebo-controlled trial involved one hundred and eight subjects (BMI between 25 and 35 kg/m2) that were randomly assigned to either the low-dose or the high-dose IQP-AE-103 group, or the placebo group. Following a 2-week run-in period, subjects received two capsules of investigational product after three daily main meals for 12 weeks. Subjects were instructed to maintain a nutritionally balanced hypocaloric diet according to the individual's energy requirement. Body weight, body fat, and waist and hip circumference were measured at baseline, and after 2, 4, 8, and 12 weeks. Subjects also rated their feelings of hunger and fullness using visual analogue scales, and food craving on a 5-point scale at the same time intervals. Blood samplings for safety laboratory parameters were taken before and at the end of the study. Results: After 12 weeks of intake, the high-dose IQP-AE-103 group had a significantly greater weight loss compared with the placebo (5.03 ± 2.50 kg vs. 0.98 ± 2.06 kg, respectively; p < 0.001) and the low-dose group (3.01 ± 2.19 kg; p=0.001). The high-dose group experienced a decrease in body fat of 3.15 ± 2.41 kg compared with a decrease of 0.23 ± 2.74 kg for the placebo group (p < 0.001). High-dose IQP-AE-103 also decreased the feeling of hunger in 66% subjects. A beneficial effect of IQP-AE-103 on the lipid metabolism was also demonstrated in the subgroup of subjects with baseline total cholesterol levels above 6.2 mmol/L. No side effects related to the intake of IQP-AE-103 were reported. Conclusions: These findings indicate that IQP-AE-103 could be an effective and safe weight loss intervention. This trial is registered with NCT03058367.

IQP-VV-102, containing L-arabinose and grape marc extract has been shown to promote weight loss. The present study investigated the efficacy of IQP-VV-102 on postprandial blood glucose reduction. Seventeen healthy overweight Caucasians were randomly allocated to three groups in a crossover design: IQP-VV-102 D1, 1290 mg; D2, 2580 mg, and placebo. The subjects consumed a test meal composed of 50 g starch and 50 g sucrose 15 min after taking the investigational products. Blood samples for analysis of glucose and insulin levels were taken immediately before, 15, 30, 45, 60, 90, 120, and 180 min after the test meal. The total PPG-AUC0-120 of IQP-VV-102 D2 and D1 groups were lower compared to placebo (i.e. -68.4 ± 101.1 mmol/l*min, p = 0.0028 and -47.4 ± 104.8 mmol/l*min, p = 0.0.0370 respectively). Cmax of blood glucose was observed after 15 min, with Cmax of D2 14% lower than placebo (6.04 ± 0.68 mmol/l versus 7.00 ± 0.79 mmol/l). A lower postprandial rise in insulin levels was observed for the IQP-VV-102 groups compared to placebo, with the D2 group showing a stronger reduction than the D1 group. In conclusion, IQP-VV-102 exhibited a dose-dependent effect in reducing postprandial blood glucose levels with no disproportionate increase in insulin levels and was well tolerated.