Udo Bongartz’s research while affiliated with Analyze & Realize ag and other places

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Publications (11)


Study design and population.
Percentage of body weight reduction from baseline throughout the 12-week study. Error bars denote standard error of mean. *Significant versus placebo. #Significant versus 104LD.
Responders with at least 3% and 5% weight loss after 12 weeks from baseline. *Significant versus placebo. #Significant versus 104LD.
Baseline characteristics of the study population
Mean changes in body weight and other parameters from baseline to week 4, week 8, and week 12, respectively
Flaxseed Mucilage (IQP-LU-104) Reduces Body Weight in Overweight and Moderately Obese Individuals in a 12-week, Three-Arm, Double-Blind, Randomized, and Placebo-Controlled Clinical Study
  • Article
  • Full-text available

February 2022

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156 Reads

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17 Citations

Udo Bongartz

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Uwe Hochmann

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Barbara Grube

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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.

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Figure 1. Schedule of study events. OTE, overall treatment effect; PSQ20, Perceived Stress Questionnaire; SF12, Short Form 12 Health Survey; URTS, upper respiratory tract symptoms; WURSS-21, Wisconsin Upper Respiratory Symptom Survey 21; PC, phone call; V, visit.
Figure 2. Disposition of participants. Number of participants is provided in parenthesis. ECG, electrocardiogram; FAS, full analysis set; IP, investigational products; VCAS, valid case analysis set.
Figure 3. Global assessment of benefits and tolerability of IQP-AS-119. The differences in ratings for benefits and tolerability were not statistically significant between investigators and participants (P>0.05).
Investigation of the natural supplement IQP-AS-119 for the prevention of upper respiratory tract infections in marathon race participants: A randomized, double-blind, placebo-controlled pilot study

February 2021

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113 Reads

Experimental and Therapeutic Medicine

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.


Effects of aged garlic extract on arterial elasticity in a placebo‑controlled clinical trial using EndoPAT™ technology

December 2019

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138 Reads

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9 Citations

Experimental and Therapeutic Medicine

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.



Study schedule.
Mean mAIS total score (all parameters) during the 6-week IP intake. ∗p < 0.001 vs. placebo. Error bars denote standard error of mean.
Mean scores of individual mAIS parameters throughout the study. P values for comparison against placebo.
Frequency distribution, global assessment of benefit by investigator and subjects.
Sleep Promoting Effects of IQP-AO-101: A Double-Blind, Randomized, Placebo-Controlled Exploratory Trial

May 2019

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218 Reads

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2 Citations

Evidence-based Complementary and Alternative Medicine

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.


Flowchart of the study population. IP = investigational product, LD = low dose, HD = high dose, v = visit, FAS = full analysis set.
Mean body weight over time in percentage relative to baseline weight. LD = low dose; HD = high dose. Error bars denote standard error of mean. (a) significant vs. placebo and (b) significant vs. IQP-AE-103 LD.
Responder rate for subjects who lost ≥3% and ≥5% of initial body weight at v6. LD = low dose; HD = high dose. ap<0.001 vs. placebo; bp=0.026 vs. placebo; cp=0.015 vs. low-dose group.
Double-Blind, Randomized, Three-Armed, Placebo-Controlled, Clinical Investigation to Evaluate the Benefit and Tolerability of Two Dosages of IQP-AE-103 in Reducing Body Weight in Overweight and Moderately Obese Subjects

February 2019

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229 Reads

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13 Citations

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.


A double-blind, randomized, placebo-controlled, three-way crossover clinical investigation to evaluate the effect of IQP-VV-102 on postprandial blood glucose reduction

June 2018

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327 Reads

PharmaNutrition

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.




Citations (5)


... The abundant mucilage in flaxseed cake can be freeze-dried or vacuum-dried and then stored to create a stable powder that can be utilized as an emulsifier and thickener in the food industry. The main constituents of the soluble fiber fraction are mucilage gums, while the insoluble fiber fraction mostly consists of cellulose and lignin (Bongartz et al., 2022). Monosaccharides from FC are composed of a mixture of polymers namely; arabinoxylans, galactose and fructose. ...

Reference:

Use of flaxseed cake as a source of nutrients in the food industry and possible health benefits- a review
Flaxseed Mucilage (IQP-LU-104) Reduces Body Weight in Overweight and Moderately Obese Individuals in a 12-week, Three-Arm, Double-Blind, Randomized, and Placebo-Controlled Clinical Study

... AGE is reported to be beneficial for patients with hypertension (31), atherosclerosis (32), and metabolic syndrome (33). Furthermore, recent findings have indicated that AGE suppresses inflammation and subsequent tissue destruction in the gingiva, thereby preventing the progression of periodontal disease (11)(12)(13)(14)(15). ...

Effects of aged garlic extract on arterial elasticity in a placebo‑controlled clinical trial using EndoPAT™ technology

Experimental and Therapeutic Medicine

... However, 23 out of 98 participants verbally reported positive improvements in sleep quality during the study follow-up. Other studies have investigated healthy adults with moderate sleep problems (as defined by the Pittsburgh Sleep Quality Index (PSQI), score of 6-15) and found that 6 weeks of a daily formulation containing 80 mg of lemon balm (standardised to ≥2% RA content but no phytochemical screening reported) induced significant improvements in sleep quality and better daytime functioning using the modified Athens Insomnia Scale (mAIS) relative to a placebo [57]. Daytime benefits included the perception of feeling refreshed upon awakening and overall well-being. ...

Sleep Promoting Effects of IQP-AO-101: A Double-Blind, Randomized, Placebo-Controlled Exploratory Trial

Evidence-based Complementary and Alternative Medicine

... Cheon (2020) 50 Leverrier (2019) 55 Uebelhack (2019) 58 Yousefi (2018) 63 Cho (2017) 64 Vuksan (2017) 65 Kudiganti (2016) 70 Khazaal (2015) 73 Astell (2013) 79 Chang (2013) 80 Rondanelli (2012) 93 Ross (2012) 94 Li (2010) 107 Pierro (2009) 110 Roberts (2007) 117 Roongpisuthipong (2007) 118 Abidov (2006) 120 Dellalibera (2006) 121 Greenway (2006) There were 29 studies that did not report on the compliance monitoring methods they undertook. The most used compliance monitoring method was patient diary recording (n = 28). ...

Double-Blind, Randomized, Three-Armed, Placebo-Controlled, Clinical Investigation to Evaluate the Benefit and Tolerability of Two Dosages of IQP-AE-103 in Reducing Body Weight in Overweight and Moderately Obese Subjects

... IQP-VV-102 was shown to be effective in promoting weight loss in overweight and obese subjects [17]. In the present study, we investigated the effect of IQP-VV-102 on postprandial glucose levels in overweight Caucasian subjects. ...

IQP-VV-102, a Novel Proprietary Composition for Weight Reduction: A Double-Blind Randomized Clinical Trial for Evaluation of Efficacy and Safety

Evidence-based Complementary and Alternative Medicine