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Consort flow chart and investigation design. Randomized controlled 5-month clinical investigation to study the metabolic effects of the IHMP.
Source publication
Background. Excessive energy intake has been implicated in diabetes, hypertension, coronary artery disease, and obesity. Dietary restraint has been unsuccessful as a method for the self-regulation of eating. Recognition of initial hunger (IH) is easily learned, can be validated by associated blood glucose (BG) concentration, and may improve insulin...
Contexts in source publication
Context 1
... unit diagnoses and treats celiac disease in children and adults. Aged 18 to 60 years, subjects suffered from symptoms of functional bowel disorders such as dyspepsia, abdominal pain, and diarrhoea ( Figure 1) [18,19]. They showed no morphological, physical, or biochemical signs of organic disease [11,18,19]. ...Context 2
... showed no morphological, physical, or biochemical signs of organic disease [11,18,19]. Subjects with impaired glucose tolerance (fasting plasma-glucose >115 mg/dL (6.4 mmol/L)), and noninsulin dependent dia- betes mellitus (NIDDM), celiac, liver, heart, brain, thyroid, and kidney diseases were excluded from this study (Figure 1). Written informed consent was obtained from all subjects. ...Context 3
... The trained group continued their regular work or recreational activities under tutorial assistance for seven weeks and maintained the IHMP for a further three months independently (Figure 1). ...Context 4
... after the first 7 weeks, subjects relied upon the identified subjective sensation (IH) alone, as the signal to begin a meal. Control subjects (N = 31) were given the same information on food energy content and were recommended vegetable intake and physical activity per day as were the trained subjects (weeks 0-7, Figure 1). ...Context 5
... dietician kept the list and subsequently assigned each recruited subject to the first empty list place. Control or training destination was revealed after the first visit ( Figure 1). ...Context 6
... training effect and correlations between the two body size parameters (weight and BMI), the two energy- balance parameters (arm and skinfold thickness), the four metabolic indexes (mean BG and HbA1c values, and BG and insulin AUCs), and three intake factors (energy, fruit, and vegetable) were longitudinally investigated (i.e., on post minus predifferences) by simple, linear correlation and regression analyses in all of the 120 subjects completing the study (Figure 1). Results were validated by chi square test- collinearity diagnostics-residual analysis. ...Context 7
... were validated by chi square test- collinearity diagnostics-residual analysis. Figure 1 shows the flow chart of participants through each phase of the study. Data were eventually collected from 120 subjects who completed the study (60 females and 60 males, 89 trained subjects and 31 control subjects). ...Context 8
... in the training group (females: 84.3 ± 8.7 mg/dL; N = 46; and males: 87.5 ± 10.6 mg/dL; N = 43; P = .115), the measurements from both genders were pooled in each group (Figure 1). Baseline BG means of the control subjects (85.2±8.1 mg/dL; N = 31) did not differ from those of the training subjects (85.9±9.7 mg/dL; N = 89; P = .733). ...Citations
... Over a 2-4 week period, participants are trained to eat when two conditions are met: (1) the desire to eat is present and (2) current, preprandial glucose levels are at or below their personalized threshold. This pattern of eating, when glucose is low ("low-glucose eating, " LGE), has resulted in clinically relevant weight losses, increased insulin sensitivity and reduced HbA1c in populations without diabetes (30, 35), and improved metabolic and cancer risk biomarkers among women with obesity who are at risk for postmenopausal breast cancer of a magnitude similar to that produced by time-restricted eating in similar populations (26). To date, however, the promise of LGE to modify measures of GV has yet to be investigated as a possible cancer prevention strategy. ...
... management, and behavior change to help prevent or delay the onset of diabetes in those at high risk. The GGE protocol was adapted from prior research (35,36) and consisted of up to 3 weeks of unblinded CGM-assisted LGE training during which the women learned to eat based on symptoms of hunger they experienced with their glucose levels neared fasting (averaged from two, morning fasting glucose levels). Women were randomized (1:1) to a DPP-only group or a DPP + GGE group. ...
Background
High glycemic variability (GV) is a biomarker of cancer risk, even in the absence of diabetes. The emerging concept of chrononutrition suggests that modifying meal timing can favorably impact metabolic risk factors linked to diet-related chronic disease, including breast cancer. Here, we examined the potential of eating when glucose levels are near personalized fasting thresholds (low-glucose eating, LGE), a novel form of timed-eating, to reduce GV in women without diabetes, who are at risk for postmenopausal breast cancer.
Methods
In this exploratory analysis of our 16-week weight loss randomized controlled trial, we included 17 non-Hispanic, white, postmenopausal women (average age = 60.7 ± 5.8 years, BMI = 34.5 ± 6.1 kg/m², HbA1c = 5.7 ± 0.3%). Participants were those who, as part of the parent study, provided 3–7 days of blinded, continuous glucose monitoring data and image-assisted, timestamped food records at weeks 0 and 16. Pearson’s correlation and multivariate regression were used to assess associations between LGE and GV, controlling for concurrent weight changes.
Results
Increases in LGE were associated with multiple unfavorable measures of GV including reductions in CGM glucose mean, CONGA, LI, J-Index, HBGI, ADDR, and time spent in a severe GV pattern (r = −0.81 to −0.49; ps < 0.044) and with increases in favorable measures of GV including M-value and LBGI (r = 0.59, 0.62; ps < 0.013). These associations remained significant after adjusting for weight changes.
Conclusion
Low-glucose eating is associated with improvements in glycemic variability, independent of concurrent weight reductions, suggesting it may be beneficial for GV-related disease prevention. Further research in a larger, more diverse sample with poor metabolic health is warranted.
Clinical trial registration: ClinicalTrials.gov, NCT03546972.
... Glucose-guided eating (GGE) is a timed eating paradigm that promotes metabolic homeostasis by deterring energy intake when circulating glucose is the primary source of fuel. GGE (historically called "hunger recognition" and "hunger training") has been tested over the past 2 decades in adults without diabetes who often experience overweight or obesity [1][2][3][4][5][6][7][8][9][10]. GGE involves learning to eat only when physically hungry. ...
... kg after 6 months of GGE, which included 2 weeks of glucose and hunger monitoring [2]. Early research by Ciampolini et al [10] showed significant improvements in insulin sensitivity among 89 people without diabetes who followed GGE for 5 months. Similarly, we have shown that among women at risk for postmenopausal breast cancer and a BMI ≥27 kg/m 2 , those who followed a low-glucose eating pattern consistent with GGE over a 16-week intervention period have more favorable metabolic outcomes, including improvements in insulin resistance, than those who followed a high-glucose eating pattern, independent of weight changes [8]. ...
Background:
Glucose-guided eating (GGE) improves metabolic markers of chronic disease risk, including insulin resistance, in adults without diabetes. GGE is a timed eating paradigm that relies on experiencing feelings of hunger and having a preprandial glucose level below a personalized threshold computed from 2 consecutive morning fasting glucose levels. The dawn phenomenon (DP), which results in elevated morning preprandial glucose levels, could cause typically derived GGE thresholds to be unacceptable or ineffective among people with type 2 diabetes (T2DM).
Objective:
The aim of this study is to quantify the incidence and day-to-day variability in the magnitude of DP and examine its effect on morning preprandial glucose levels as a preliminary test of the feasibility of GGE in adults with T2DM.
Methods:
Study participants wore a single-blinded Dexcom G6 Pro continuous glucose monitoring (CGM) system for up to 10 days. First and last eating times and any overnight eating were reported using daily surveys over the study duration. DP was expressed as a dichotomous variable at the day level (DP day vs non-DP day) and as a continuous variable reflecting the percent of days DP was experienced on a valid day. A valid day was defined as having no reported overnight eating (between midnight and 6 AM). ∂ Glucose was computed as the difference in nocturnal glucose nadir (between midnight and 6 AM) to morning preprandial glucose levels. ∂ Glucose ≥20 mg/dL constituted a DP day. Using multilevel modeling, we examined the between- and within-person effects of DP on morning preprandial glucose and the effect of evening eating times on DP.
Results:
In total, 21 adults (59% female; 13/21, 62%) with non-insulin-treated T2DM wore a CGM for an average of 10.5 (SD 1.1) days. Twenty out of 21 participants (95%) experienced DP for at least 1 day, with an average of 51% of days (SD 27.2; range 0%-100%). The mean ∂ glucose was 23.7 (SD 13.2) mg/dL. People who experience DP more frequently had a morning preprandial glucose level that was 54.1 (95% CI 17.0-83.9; P<.001) mg/dL higher than those who experienced DP less frequently. For within-person effect, morning preprandial glucose levels were 12.1 (95% CI 6.3-17.8; P=.008) mg/dL higher on a DP day than on a non-DP day. The association between ∂ glucose and preprandial glucose levels was 0.50 (95% CI 0.37-0.60; P<.001). There was no effect of the last eating time on DP.
Conclusions:
DP was experienced by most study participants regardless of last eating times. The magnitude of the within-person effect of DP on morning preprandial glucose levels was meaningful in the context of GGE. Alternative approaches for determining acceptable and effective GGE thresholds for people with T2DM should be explored and evaluated.
... Glucose-guided eating (GGE) is a timed eating paradigm that promotes metabolic homeostasis by deterring energy intake when circulating glucose is the primary source of fuel. GGE (historically called "hunger recognition" and "hunger training") has been tested over the past 2 decades in adults without diabetes who often experience overweight or obesity [1][2][3][4][5][6][7][8][9][10]. GGE involves learning to eat only when physically hungry. ...
... kg after 6 months of GGE, which included 2 weeks of glucose and hunger monitoring [2]. Early research by Ciampolini et al [10] showed significant improvements in insulin sensitivity among 89 people without diabetes who followed GGE for 5 months. Similarly, we have shown that among women at risk for postmenopausal breast cancer and a BMI ≥27 kg/m 2 , those who followed a low-glucose eating pattern consistent with GGE over a 16-week intervention period have more favorable metabolic outcomes, including improvements in insulin resistance, than those who followed a high-glucose eating pattern, independent of weight changes [8]. ...
BACKGROUND
Glucose-guided eating (GGE) improves metabolic markers of chronic disease risk, including insulin resistance, in adults without diabetes. GGE is a timed eating paradigm that relies on experiencing feelings of hunger and having a preprandial glucose level below a personalized threshold computed from 2 consecutive morning fasting glucose levels. The dawn phenomenon (DP), which results in elevated morning preprandial glucose levels, could cause typically derived GGE thresholds to be unacceptable or ineffective among people with type 2 diabetes (T2DM).
OBJECTIVE
The aim of this study is to quantify the incidence and day-to-day variability in the magnitude of DP and examine its effect on morning preprandial glucose levels as a preliminary test of the feasibility of GGE in adults with T2DM.
METHODS
Study participants wore a single-blinded Dexcom G6 Pro continuous glucose monitoring (CGM) system for up to 10 days. First and last eating times and any overnight eating were reported using daily surveys over the study duration. DP was expressed as a dichotomous variable at the day level (DP day vs non-DP day) and as a continuous variable reflecting the percent of days DP was experienced on a valid day. A valid day was defined as having no reported overnight eating (between midnight and 6 AM). ∂ Glucose was computed as the difference in nocturnal glucose nadir (between midnight and 6 AM) to morning preprandial glucose levels. ∂ Glucose ≥20 mg/dL constituted a DP day. Using multilevel modeling, we examined the between- and within-person effects of DP on morning preprandial glucose and the effect of evening eating times on DP.
RESULTS
In total, 21 adults (59% female; 13/21, 62%) with non–insulin-treated T2DM wore a CGM for an average of 10.5 (SD 1.1) days. Twenty out of 21 participants (95%) experienced DP for at least 1 day, with an average of 51% of days (SD 27.2; range 0%-100%). The mean ∂ glucose was 23.7 (SD 13.2) mg/dL. People who experience DP more frequently had a morning preprandial glucose level that was 54.1 (95% CI 17.0-83.9; P <.001) mg/dL higher than those who experienced DP less frequently. For within-person effect, morning preprandial glucose levels were 12.1 (95% CI 6.3-17.8; P =.008) mg/dL higher on a DP day than on a non-DP day. The association between ∂ glucose and preprandial glucose levels was 0.50 (95% CI 0.37-0.60; P <.001). There was no effect of the last eating time on DP.
CONCLUSIONS
DP was experienced by most study participants regardless of last eating times. The magnitude of the within-person effect of DP on morning preprandial glucose levels was meaningful in the context of GGE. Alternative approaches for determining acceptable and effective GGE thresholds for people with T2DM should be explored and evaluated.
... T2-T0) T1-T0 T2-T0 T1-T0 T2-T0 T1-T0 T2-T0 T1-T0 T2- Another important aspect of this study is our focus on healthcentered rather than weight loss-centered treatment. Weight reduction was not considered the main focus during the intervention, because of the questionable results of traditional approaches based on restrictive diets [63]. However, most of our participants were waiting for bariatric surgery and had tried to lose weight multiple times. ...
... In that study of overweight or individuals with obesity, intuitive eating was applied to acceptance and commitment therapy in group meetings and also individually via a mobile application for eight weeks. Of note, many cross-sectional studies have shown an inverse relationship between intuitive eating and BMI [30,41,32,65,66,67,68,63,70,71] including in clinical trial [45]. ...
Background and aims
Dysfunctional eating behaviors may be associated with weight gain and have a negative impact on obesity. Intuitive eating is a strategy that helps with changing eating behaviors. This study aimed to analyze the effects of intuitive eating alone or combined with nutritional guidelines on eating behaviors, weight, and body mass index (BMI), in individuals with obesity.
Methods
This is a randomized clinical trial of 58 individuals (84.5% females and 84.5% candidates for bariatric surgery). The mean age was 40.5 years (SD = 9.1). The mean BMI was 48.3 kg/m² (SD = 7.4). Individuals were randomized into three groups: 1) the control group (CG; n = 18), who received an individualized meal plan, 2) the intuitive eating group (IEG; n = 23), and 3) the intuitive eating and nutritional guidelines application group (IEGDG; n = 17). The study lasted for six months. Eating behaviors were assessed using the Binge Eating Scale and Three Factor Eating Questionnaire, the 21-item version.
Results
Compared with the CG, the IEG and IEGDG did not differ in binge eating, cognitive restriction, emotional eating, and uncontrolled eating. Likewise, there were no significant differences in weight and BMI.
Conclusions
: Intuitive eating alone or in combination with nutritional guidelines did not alter the general domains of eating behaviors, weight, and BMI in individuals with obesity. We suggest further studies involving other health professionals, as well as evaluating the effects of intuitive eating using scales, in addition to eating behaviors.
Clinical trial registration
https://ensaiosclinicos.gov.br6, Identifier: RBR-7q9nj8.
... The modification of glucose eating patterns by GGE is feasible [33,36] and has resulted in clinically significant, average weight loss of 7.4% in 5 months and improvements in eating behavior (including reductions in hedonic eating) and cancer-related risk biomarkers [34,[36][37][38][39]. GGE has resulted in improvements in whole-body insulin sensitivity by 31% (Matsuda index, 7.1 ± 4.1 to 9.4 ± 5.2) in non-diabetic, lean adults (BMI = 23 ± 4 kg/m 2 ) [38]. ...
Postmenopausal breast cancer is the most common obesity-related cancer death among women in the U.S. Insulin resistance, which worsens in the setting of obesity, is associated with higher breast cancer incidence and mortality. Maladaptive eating patterns driving insulin resistance represent a key modifiable risk factor for breast cancer. Emerging evidence suggests that time-restricted feeding paradigms (TRF) improve cancer-related metabolic risk factors; however, more flexible approaches could be more feasible and effective. In this exploratory, secondary analysis, we identified participants following a low-glucose eating pattern (LGEP), defined as consuming energy when glucose levels are at or below average fasting levels, as an alternative to TRF. Results show that following an LGEP regimen for at least 40% of reported eating events improves insulin resistance (HOMA-IR) and other cancer-related serum biomarkers. The magnitude of serum biomarkers changes observed here has previously been shown to favorably modulate benign breast tissue in women with overweight and obesity who are at risk for postmenopausal breast cancer. By comparison, the observed effects of LGEP were similar to results from previously published TRF studies in similar populations. These preliminary findings support further testing of LGEP as an alternative to TRF and a postmenopausal breast cancer prevention strategy. However, results should be interpreted with caution, given the exploratory nature of analyses.
... The impact on energy intake, dietary quality and other physical indicators of health (e.g. blood pressure, lipids and glucose) is less clear, although improvements have also been documented in those domains (8,15,16,21,(25)(26)(27)(28)(29)(30)(31) . ...
... Ciampolini and colleagues have shown that training individuals to link their subjective feeling of hunger to an objective marker (blood glucose levels), with the purpose of re-learning to identify physical hunger and responding to it, leads to positive outcomes (e.g. reduced premeal blood glucose, insulin sensitivity, blood glucose peaks, energy intake and body weight) (25,26,67) . Furthermore, obese individuals and those with eating disorders (e.g. ...
... Finally, the main practical contribution of this paper is that it portrays the most important areas to intervene in order to promote the internally regulated eating style. Strategies like coupling subjective sensations of hunger and satiation with objective markers can be used to enhance sensitivity to and self-efficacy in using these signals to regulate food intake (25,26,67) . This could be done in combination with strategies aimed at increasing the awareness and reducing the responsiveness to external or emotional cues of food intake (39,143) since such cues can have an important influence on food intake. ...
Internally regulated eating style, the eating style that is driven by internal bodily sensations of hunger and satiation, is a concept that has received increasing attention in the literature and health practice over the last decades. The various attempts that have been made so far to conceptualize internally regulated eating have taken place independently of one another and each sheds light on only parts of the total picture of what defines internally regulated eating. This has resulted in a literature that is rather fragmented. More importantly, it is not yet clear which are the characteristics that comprise this eating style. In this paper, we identify and describe the full spectrum of these characteristics, namely, sensitivity to internal hunger and satiation signals, self-efficacy in using internal hunger and satiation signals, self-trusting attitude for the regulation of eating, relaxed relationship with food, and tendency to savor the food while eating. With this research, we introduce a common language to the field and we present a new theoretical framework that does justice not just to the full breadth of characteristics that are necessary for the internally regulated eating style but also to the associations between them and the potential mechanisms by which they contribute to this eating style.
... The impact on energy intake, dietary quality and other physical indicators of health (e.g. blood pressure, lipids and glucose) is less clear, although improvements have also been documented in those domains (8,15,16,21,(25)(26)(27)(28)(29)(30)(31) . ...
... Ciampolini and colleagues have shown that training individuals to link their subjective feeling of hunger to an objective marker (blood glucose levels), with the purpose of re-learning to identify physical hunger and responding to it, leads to positive outcomes (e.g. reduced premeal blood glucose, insulin sensitivity, blood glucose peaks, energy intake and body weight) (25,26,67) . Furthermore, obese individuals and those with eating disorders (e.g. ...
... Finally, the main practical contribution of this paper is that it portrays the most important areas to intervene in order to promote the internally regulated eating style. Strategies like coupling subjective sensations of hunger and satiation with objective markers can be used to enhance sensitivity to and self-efficacy in using these signals to regulate food intake (25,26,67) . This could be done in combination with strategies aimed at increasing the awareness and reducing the responsiveness to external or emotional cues of food intake (39,143) since such cues can have an important influence on food intake. ...
The concept of internally regulated eating has been explored along several, distinct research lines. The most prominent are those on intuitive eating, eating competence, and mindful eating, but there are also several independent intervention programs that promote eating by internal hunger and satiation cues (i.e., bodily sensations of hunger and satiation). Although these paradigms have certain key elements in common, they also differ in various respects. As a result, there is no consensus regarding the key features that compose the internally regulated eating style. In the present paper, we synthesize the underlying concepts that bind together the various research lines on internally regulated eating. We do this by delineating the individual-difference characteristics that form the tendency towards engaging in internally regulated eating. These include the sensitivity to and self-efficacy in using internal hunger and satiation signals, a self-trusting attitude for the regulation of eating, a relaxed relationship with food, and the tendency to savor the food while eating. Building on earlier work, we propose an inclusive definition for the internally regulated eating style, we embody this eating style in an existing, well-known model of eating behavior (the boundary model of eating), and we present a comprehensive theoretical framework with its key defining features, antecedents, and consequences, which can be used to drive future research.
... The infusion of 0.1mU/kg/min was maintained for the remainder of the procedure. Venous blood samples were taken into fluoride oxalate tubes at times: t =-10,-5,-1, 0, 1, 2, 3, 4, 5, 6, 8, 10, 12.5, 15,20,25,30,35,40,50,60,70,80,90,100,120,140,160,180,210,240, 270 and 300 minutes. Blood samples were assayed for glucose and insulin concentration using standard commercial assays (Roche Diagnostics, New Zealand) at an accredited laboratory (Diabetes and Lipid Laboratory, University of Otago, Dunedin, New Zealand). ...
... Previous studies have shown individuals with impaired glucose tolerance (IGT) tend to have a DISST SI values in the range of 2×10-DISST model's SI metric found a median SI for IGT individuals (N=5) of 4 .14×10 Table 3 shows while most participants had elevated fasting (G0) glucose levels, GTARGET was calculated closer to a normal reference range of 4.0 to 5.6 mmol•L-1 [30]. ...
Background:
Physiological models that are used with dynamic test data to assess insulin sensitivity (SI) assume that the metabolic target glucose concentration ( GTARGET) is equal to fasting glucose concentration ( G0). However, recent research has implied that irregularities in G0 in diabetes may cause erroneous SI values. This study quantifies the magnitude of these errors.
Methods:
A clinically validated insulin/glucose model was used to calculate SI with the standard fasting assumption (SFA) G0 = GTARGET. Then GTARGET was treated as a variable in a second analysis (VGT). The outcomes were contrasted across twelve participants with established type 2 diabetes mellitus that were recruited to take part in a 24-week dietary intervention. Participants underwent three insulin-modified intravenous glucose tolerance tests (IM-IVGTT) at 0, 12, and 24 weeks.
Results:
SIVGT had a median value of 3.36×10-4 L·mU-1·min-1 (IQR: 2.30 - 4.95×10-4) and were significantly lower ( P < .05) than the median SISFA (6.38×10-4 L·mU-1·min-1, IQR: 4.87 - 9.39×10-4). The VGT approach generally yielded lower SI values in line with expected participant physiology and more effectively tracked changes in participant state over the 24-week trial. Calculated GTARGET values were significantly lower than G0 values (median GTARGET = 5.48 vs G0 = 7.16 mmol·L-1 P < .001) and were notably higher in individuals with longer term diabetes.
Conclusions:
Typical modeling approaches can overestimate SI when GTARGET does not equal G0. Hence, calculating GTARGET may enable more precise SI measurements in individuals with type 2 diabetes, and could imply a dysfunction in diabetic metabolism.
... Yet the diarrhea relapses in children were associated with high blood glucose (BG) [6]. BG elevation and long persistence of nutrients in the bowel are frequent events during changes in climate or in home heating and during emotions [7][8][9][10][11][12]. These events (of no metabolic adaptation) prevail more and more in the evolution from insulin resistance to diabetes [13][14][15][16][17][18][19]. ...
... Overall inflammation multiplies cellular reproduction in all body tissues. DNA replications increase and produce more and more replication errors in DNA [9][10][11][12]. After decades of accelerated replications, malignancy development becomes unavoidable. ...
... After decades of accelerated replications, malignancy development becomes unavoidable. Although frequent however, high MBG and insulin resistance are not generalized and may be reversed to low MBG and insulin sensitivity by changes in meal pattern [9][10][11][12]. ...
... A similar attempt in NIDD diabetics failed in preventing cardiovascular untoward events [30], but the body weight decrease was only 7% of initial body weight. The expertise on meal by meal dynamic maintenance of energy balance [31] might be necessary for further body weight loss and for a long period maintenance of the body weight loss [14]. Body weight loss is rather easy in NIDD diabetics because painful hunger and low BG levels do not emerge. ...
