The RepEAT Study: Individual Differences in Postprandial Glucose Responses and the Relation With Diet and Phenotype
- Conditions
- Postprandial Glucose ResponsesGlucose Metabolism
- Registration Number
- NCT05456815
- Lead Sponsor
- Wageningen University
- Brief Summary
Postprandial glucose responses are related to an increased risk of developing cardiometabolic diseases. Existing research recognizes the presence of inter-individual variation in postprandial glucose responses to the same meal or food product. However, the role of diet and phenotype in postprandial glucose responses is unclear.
The primary objective of this study is to determine the variation in postprandial glucose responses to the same meals/food products and how this relates to the variation in postprandial glucose responses over a 9-week fully controlled dietary intervention within and between individuals. Our secondary objectives are to investigate the difference between postprandial glucose responses to original products and postprandial glucose responses to reformulated products, and to examine the relation between postprandial glucose responses and short-term well-being. In addition, we aim to study the relation between variation in postprandial glucose and phenotype, including immune function, cognitive performance, and microbiota composition.
63 apparently healthy men and women with a BMI of 25-40 kg/m2, aged 45-75 years will be included in the study, comprising a characterization period of 3 weeks and a completely controlled dietary intervention of 9 weeks. During these 9 weeks, glucose will be continuously monitored to measure postprandial glucose responses to standard foods/meals.
There are minor risks for the research subjects of this study. Research subjects will invest approximately 85 hours in the study. During the characterization week, subjects will visit the Wageningen University 3 times and Hospital Gelderse Vallei (Ede, The Netherlands) once. During the controlled dietary intervention, subjects will visit the Wageningen University 2-3 times a week.
- Detailed Description
Postprandial glucose responses are related to an increased risk of developing cardiometabolic diseases. Existing research recognizes the presence of inter-individual variation in postprandial glucose responses to the same meal or food product. However, the role of diet, i.e. the other consumed food products and meals, and phenotype in postprandial glucose responses is unclear. A repetitive design and a standardized diet are necessary to determine the variation in postprandial glucose responses to a meal or food product irrespective of the diet.
The primary objective of this study is to determine the variation in postprandial glucose responses to the same meals/food products and how this relates to the variation in postprandial glucose responses over a 9-week fully controlled dietary intervention within and between individuals. Our secondary objectives are to investigate the difference between postprandial glucose responses to original products and postprandial glucose responses to reformulated products, and to examine the relation between postprandial glucose responses and short-term well-being. In addition, we aim to study the relation between variation in postprandial glucose and phenotype, including immune function, cognitive performance, and microbiota composition.
The study population consists of 63 apparently healthy men and women with a BMI of 25-40 kg/m2, aged 45-75 years, and who are weight stable (± \<3 kg) for at least three months prior to inclusion.
The study comprises a characterization period of three weeks, followed by a fully controlled dietary intervention trial of nine weeks. In the characterization period, the phenotype of participants will be determined by measures on anthropometrics, immune function, oxidative stress, advanced glycation end-products, cognitive performance, microbiota and gut health, amylase, genetics, and circulating metabolites. The dietary intervention consists of three repetitive rounds of three weeks, in which we test food products in a cross-over setting. Participants will consume test products that fall in the same food category, but differ in glycaemic index/carbohydrate content. Part of these products is provided by industrial partners, of which the original products are reformulated to be reduced in glycaemic index/carbohydrate content. During the 9-week dietary intervention all foods are provided, giving us a complete and detailed picture of food and nutrient intake during this period. The standardized diet follows the average consumption pattern of the study population. Throughout the intervention, interstitial glucose concentrations will be measured using continuous glucose monitoring (CGM) and physical activity will be monitored with an accelerometer.
This study is related to a broad general population. There are minor risks for the research subjects of this study. Placing a continuous glucose sensor generally does not cause pain, but could result in the loss of a drop of blood, or slight skin irritation after wearing. Blood sampling will be performed via a cannula or venapunction and the insertion can be a bit painful and may cause a bruise. During the characterization period, in total 215 mL of blood will be collected in a 3-week timespan. In the following 9 weeks 108 mL, and at the end of the intervention 34 mL blood will be collected. Research subjects will invest approximately 85 hours in the study. During the characterization week, subjects will visit the Wageningen University 3 times and Hospital Gelderse Vallei (Ede, The Netherlands) once. During the controlled dietary intervention, subjects will visit the Wageningen University 2-3 times a week.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
- Apparently healthy men and women
- BMI of 25 - 40 kg/m2
- Age 45-75 years
- Weight stable (± <3 kg) for at least two months prior to inclusion
- Diagnosed with type 1 or type 2 diabetes
- Diseases or prior surgeries affecting the stomach, liver, or intestines
- Food allergies/intolerances for products used in the study design
- Receiving medication or supplements interfering with glucose metabolism (as judged by our research physician)
- Regular use of medication interfering with immune function (e.g. corticosteroids, immune blockers, as judged by our research physician)
- Donated blood within 2 months prior to the screening
- Anaemia defined as Hb concentrations <8.5 mmol/L for men and <7.5 mmol/L for women
- Veins not suitable for venflon needle
- Allergy/intolerance to medical skin adhesives
- Dietary habits interfering with the study design (e.g. vegetarian, vegan, ketogenic diet)
- Intention to change the intensity of exercise during the study period
- Current smokers
- Alcohol intake ≥14 alcoholic beverages per week (women) or ≥21 alcoholic beverages per week (men)
- Being pregnant or lactating
- Use of soft and/or hard drugs
- Unable/unwilling to download a research application on the mobile phone
- Participation in another study that involves an intervention within two months prior to the intervention
- Working at the division of Human Nutrition and Health of Wageningen University and Research or the Food, Health and Consumer research group of Wageningen University and Biobased Research
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Blood glucose profile Continuous for 9 weeks Interstitial glucose concentrations, as measured by continuous glucose monitoring
- Secondary Outcome Measures
Name Time Method Plasma insulin response fries C 2 hours post-ingestion Plasma insulin response to fries type C
PBMC cytokine production End of intervention (week 12) PBMC cytokine production as measured by intracellular staining
Fasting glucose concentration Baseline Fasting glucose concentration
Plasma insulin response yoghurt B 2 hours post-ingestion Plasma insulin response to yoghurt type B
Postprandial glucose blood levels 240 minutes post-ingestion Postprandial glucose responses in blood upon a mixed meal challenge
Cholesterol concentration Baseline Fasting plasma cholesterol concentration
Postprandial blood glucose levels 120 minutes post-ingestion Postprandial glucose responses in blood upon an oral glucose tolerance test
Postprandial blood insulin levels 120 minutes post-ingestion Postprandial insulin responses in blood upon an oral glucose tolerance test
Postprandial gut hormone blood levels 240 minutes post-ingestion Postprandial gut hormone concentrations in blood upon a mixed meal challenge
HbA1c Baseline HbA1c
PBMC composition End of intervention (week 12) Immune function as measured by PBMC composition
Short-term well-being 4 hours post-ingestion Short-term well-being upon investigational product consumption assessed by the Multidimensional Mood Questionnaire (MDMQ)
Postprandial fatty acid blood levels 240 minutes post-ingestion Postprandial fatty acid concentrations in blood upon a mixed meal challenge
Physical activity Continuous for 3 non-consecutive weeks between week 1 and week 9 of the dietary intervention Continuous physical activity levels, measured by ActivPAL3 micro (PAL Technologies, Glasgow, Scotland) during 3 non-consecutive weeks
Liver fat content Baseline Liver fat content as measured by MRS
Fasting insulin concentration Baseline Fasting insulin concentration
Circulating cytokines Baseline Circulating plasma cytokines
Immune response End of intervention (week 12) Immune response upon TLR stimulation
Oxidative stress marker urine End of intervention (week 12) Oxidative stress as measured by free 8-iso PGF2a in urine
Alpha-dicarbonyl concentrations blood End of intervention (week 12) alpha-dicarbonyl concentrations in plasma as measured by ultraperformance liquid chromatography-tandem mass spectrometry
Postprandial insulin blood levels 240 minutes post-ingestion Postprandial insulin responses in blood upon a mixed meal challenge
Postprandial metabolite blood levels 240 minutes post-ingestion Postprandial responses in blood upon a mixed meal challenge as measured by metabolomics
Postprandial lipid profiling 240 minutes post-ingestion Postprandial lipid profiling in blood upon a mixed meal challenge
Body fat distribution Baseline Ratio between visceral and subcutaneous adipose tissue as measured by magnetic resonance imaging (MRI)
Metabolism immune cell populations Baseline Metabolism of immune cell populations as measured by SCENITH
Advanced glycation end-products (AGEs) blood End of intervention (week 12) AGE concentrations in plasma as measured by ultraperformance liquid chromatography-tandem mass spectrometry
Salivary amylase activity End of intervention (week 12) Activity of salivary amylase
Plasma glucose response fries A 2 hours post-ingestion Plasma glucose response to fries type A
Plasma glucose response yoghurt B 2 hours post-ingestion Plasma glucose response to yoghurt type B
Immune function End of intervention (week 12) Metabolism of immune cell populations as measured by SCENITH
Cognitive performance Baseline Cognitive performance as measured by the Cambridge Neuropsychological Test Automated Battery
Genetic variation metabolism and responses to food Baseline SNPs in genes relevant for metabolism and responses to food, collected using a mouth swab
Plasma glucose response cake B 2 hours post-ingestion Plasma glucose response to cake type B
Oxidative stress in plasma End of intervention (week 12) Oxidative stress as measured by nitrotyrosine in plasma
Oral microbiota composition Week 9 dietary intervention Microbiota composition in the saliva by extracting bacterial DNA for 16S rRNA sequencing
Self-reported stool consistency Week 9 dietary intervention Self-reported stool consistency by using the bristol stool chart (scores between 1-7). Low scores indicate constipation and high scores diarrhea. Scores of 3-4 indicate a 'normal' stool.
Habitual dietary intake Baseline Habitual dietary intake assessment with a food frequency questionnaire (FFQ)
Plasma glucose response cake C 2 hours post-ingestion Plasma glucose response to cake type C
Plasma insulin response fries A 2 hours post-ingestion Plasma insulin response to fries type A
AGE accumulation End of intervention (week 12) Accumulation of AGEs in the skin as measured by an AGE reader (Diagnoptics, Groningen, the Netherlands)
Fecal microbiota composition Week 9 dietary intervention Microbiota composition in the feces by extracting bacterial DNA for 16S rRNA sequencing
Transit time End of intervention (week 12) Transit time, measured as the time in with blue (dietary) dye is consumed and observed in the feces
Salivary amylase concentration End of intervention (week 12) Concentration of salivary amylase
Plasma glucose response cake A 2 hours post-ingestion Plasma glucose response to cake type A
Plasma insulin response fries B 2 hours post-ingestion Plasma insulin response to fries type B
Plasma insulin response yoghurt A 2 hours post-ingestion Plasma insulin response to yoghurt type A
Plasma insulin response yoghurt C 2 hours post-ingestion Plasma insulin response to yoghurt type C
Genetic variation amylase genes Baseline SNPs in genes coding for amylase, collected using a mouth swab
Plasma glucose response fries B 2 hours post-ingestion Plasma glucose response to fries type B
Plasma glucose response fries C 2 hours post-ingestion Plasma glucose response to fries type C
Plasma glucose response yoghurt A 2 hours post-ingestion Plasma glucose response to yoghurt type A
Plasma glucose response yoghurt C 2 hours post-ingestion Plasma glucose response to yoghurt type C
Plasma insulin response cake A 2 hours post-ingestion Plasma insulin response to cake type A
Plasma insulin response cake B 2 hours post-ingestion Plasma insulin response to cake type B
Plasma insulin response cake C 2 hours post-ingestion Plasma insulin response to cake type C
Trial Locations
- Locations (1)
Wageningen University, Division of Human Nutrition
🇳🇱Wageningen, Gelderland, Netherlands
Wageningen University, Division of Human Nutrition🇳🇱Wageningen, Gelderland, Netherlands