Postprandial Glucose ResponsesRepEATNCT05456815
The RepEAT Study: Individual Differences in Postprandial Glucose Responses and the Relation With Diet and Phenotype
A study testing Standardized diet in people with Postprandial Glucose Responses and Glucose Metabolism, run by Wageningen University at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Glucose Responses, Glucose Metabolism
- What is being tested?
- Standardized diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteNetherlands
- Study dates
- 26 Aug 2022to 13 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Wageningen University, Division of Human Nutrition
Wageningen, Gelderland, 6700 EV
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Postprandial Glucose Responses, Glucose Metabolism
- Being tested
- Standardized diet
- Keywords
- Postprandial, Glucose, Standardized diet, Continuous monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized dietOther
Also called 9-week fully controlled dietary intervention
During 9 weeks all food products will be standardized and provided by the Research Unit. The standardized diet is based on the average food composition in the Netherlands.
| Study group | Role | What they receive |
|---|---|---|
| Standardized diet | Other | Standardized food products/meals will be tested Receives: Other: Standardized diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose profile
Interstitial glucose concentrations, as measured by continuous glucose monitoring
Measured: Continuous for 9 weeks
Secondary outcomes (165)
Short-term well-being
Short-term well-being upon investigational product consumption assessed by the Multidimensional Mood Questionnaire (MDMQ)
Measured: Baseline
Short-term well-being
Short-term well-being upon investigational product consumption assessed by the Multidimensional Mood Questionnaire (MDMQ)
Measured: 1 hour post-ingestion
Short-term well-being
Short-term well-being upon investigational product consumption assessed by the Multidimensional Mood Questionnaire (MDMQ)
Measured: 2 hours post-ingestion
Short-term well-being
Short-term well-being upon investigational product consumption assessed by the Multidimensional Mood Questionnaire (MDMQ)
Measured: 4 hours post-ingestion
Postprandial glucose blood levels
Postprandial glucose responses in blood upon a mixed meal challenge
Measured: Baseline
Postprandial glucose blood levels
Postprandial glucose responses in blood upon a mixed meal challenge
Measured: 30 minutes post-ingestion
Postprandial glucose blood levels
Postprandial glucose responses in blood upon a mixed meal challenge
Measured: 60 minutes post-ingestion
Postprandial glucose blood levels
Postprandial glucose responses in blood upon a mixed meal challenge
Measured: 90 minutes post-ingestion
Postprandial glucose blood levels
Postprandial glucose responses in blood upon a mixed meal challenge
Measured: 120 minutes post-ingestion
Postprandial glucose blood levels
Postprandial glucose responses in blood upon a mixed meal challenge
Measured: 180 minutes post-ingestion
Postprandial glucose blood levels
Postprandial glucose responses in blood upon a mixed meal challenge
Measured: 240 minutes post-ingestion
Postprandial insulin blood levels
Postprandial insulin responses in blood upon a mixed meal challenge
Measured: Baseline
Postprandial insulin blood levels
Postprandial insulin responses in blood upon a mixed meal challenge
Measured: 30 minutes post-ingestion
Postprandial insulin blood levels
Postprandial insulin responses in blood upon a mixed meal challenge
Measured: 60 minutes post-ingestion
Postprandial insulin blood levels
Postprandial insulin responses in blood upon a mixed meal challenge
Measured: 90 minutes post-ingestion
Postprandial insulin blood levels
Postprandial insulin responses in blood upon a mixed meal challenge
Measured: 120 minutes post-ingestion
Postprandial insulin blood levels
Postprandial insulin responses in blood upon a mixed meal challenge
Measured: 180 minutes post-ingestion
Postprandial insulin blood levels
Postprandial insulin responses in blood upon a mixed meal challenge
Measured: 240 minutes post-ingestion
Postprandial metabolite blood levels
Postprandial responses in blood upon a mixed meal challenge as measured by metabolomics
Measured: Baseline
Postprandial metabolite blood levels
Postprandial responses in blood upon a mixed meal challenge as measured by metabolomics
Measured: 30 minutes post-ingestion
Postprandial metabolite blood levels
Postprandial responses in blood upon a mixed meal challenge as measured by metabolomics
Measured: 60 minutes post-ingestion
Postprandial metabolite blood levels
Postprandial responses in blood upon a mixed meal challenge as measured by metabolomics
Measured: 90 minutes post-ingestion
Postprandial metabolite blood levels
Postprandial responses in blood upon a mixed meal challenge as measured by metabolomics
Measured: 120 minutes post-ingestion
Postprandial metabolite blood levels
Postprandial responses in blood upon a mixed meal challenge as measured by metabolomics
Measured: 180 minutes post-ingestion
Postprandial metabolite blood levels
Postprandial responses in blood upon a mixed meal challenge as measured by metabolomics
Measured: 240 minutes post-ingestion
Postprandial lipid profiling
Postprandial lipid profiling in blood upon a mixed meal challenge
Measured: Baseline
Postprandial lipid profiling
Postprandial lipid profiling in blood upon a mixed meal challenge
Measured: 30 minutes post-ingestion
Postprandial lipid profiling
Postprandial lipid profiling in blood upon a mixed meal challenge
Measured: 60 minutes post-ingestion
Postprandial lipid profiling
Postprandial lipid profiling in blood upon a mixed meal challenge
Measured: 90 minutes post-ingestion
Postprandial lipid profiling
Postprandial lipid profiling in blood upon a mixed meal challenge
Measured: 120 minutes post-ingestion
Postprandial lipid profiling
Postprandial lipid profiling in blood upon a mixed meal challenge
Measured: 180 minutes post-ingestion
Postprandial lipid profiling
Postprandial lipid profiling in blood upon a mixed meal challenge
Measured: 240 minutes post-ingestion
Postprandial fatty acid blood levels
Postprandial fatty acid concentrations in blood upon a mixed meal challenge
Measured: Baseline
Postprandial fatty acid blood levels
Postprandial fatty acid concentrations in blood upon a mixed meal challenge
Measured: 30 minutes post-ingestion
Postprandial fatty acid blood levels
Postprandial fatty acid concentrations in blood upon a mixed meal challenge
Measured: 60 minutes post-ingestion
Postprandial fatty acid blood levels
Postprandial fatty acid concentrations in blood upon a mixed meal challenge
Measured: 90 minutes post-ingestion
Postprandial fatty acid blood levels
Postprandial fatty acid concentrations in blood upon a mixed meal challenge
Measured: 120 minutes post-ingestion
Postprandial fatty acid blood levels
Postprandial fatty acid concentrations in blood upon a mixed meal challenge
Measured: 180 minutes post-ingestion
Postprandial fatty acid blood levels
Postprandial fatty acid concentrations in blood upon a mixed meal challenge
Measured: 240 minutes post-ingestion
Postprandial gut hormone blood levels
Postprandial gut hormone concentrations in blood upon a mixed meal challenge
Measured: Baseline
Postprandial gut hormone blood levels
Postprandial gut hormone concentrations in blood upon a mixed meal challenge
Measured: 30 minutes post-ingestion
Postprandial gut hormone blood levels
Postprandial gut hormone concentrations in blood upon a mixed meal challenge
Measured: 60 minutes post-ingestion
Postprandial gut hormone blood levels
Postprandial gut hormone concentrations in blood upon a mixed meal challenge
Measured: 90 minutes post-ingestion
Postprandial gut hormone blood levels
Postprandial gut hormone concentrations in blood upon a mixed meal challenge
Measured: 120 minutes post-ingestion
Postprandial gut hormone blood levels
Postprandial gut hormone concentrations in blood upon a mixed meal challenge
Measured: 180 minutes post-ingestion
Postprandial gut hormone blood levels
Postprandial gut hormone concentrations in blood upon a mixed meal challenge
Measured: 240 minutes post-ingestion
Cholesterol concentration
Fasting plasma cholesterol concentration
Measured: Baseline
Postprandial blood glucose levels
Postprandial glucose responses in blood upon an oral glucose tolerance test
Measured: Baseline
Postprandial blood glucose levels
Postprandial glucose responses in blood upon an oral glucose tolerance test
Measured: 15 minutes post-ingestion
Postprandial blood glucose levels
Postprandial glucose responses in blood upon an oral glucose tolerance test
Measured: 30 minutes post-ingestion
Postprandial blood glucose levels
Postprandial glucose responses in blood upon an oral glucose tolerance test
Measured: 45 minutes post-ingestion
Postprandial blood glucose levels
Postprandial glucose responses in blood upon an oral glucose tolerance test
Measured: 60 minutes post-ingestion
Postprandial blood glucose levels
Postprandial glucose responses in blood upon an oral glucose tolerance test
Measured: 90 minutes post-ingestion
Postprandial blood glucose levels
Postprandial glucose responses in blood upon an oral glucose tolerance test
Measured: 120 minutes post-ingestion
Postprandial blood insulin levels
Postprandial insulin responses in blood upon an oral glucose tolerance test
Measured: Baseline
Postprandial blood insulin levels
Postprandial insulin responses in blood upon an oral glucose tolerance test
Measured: 15 minutes post-ingestion
Postprandial blood insulin levels
Postprandial insulin responses in blood upon an oral glucose tolerance test
Measured: 30 minutes post-ingestion
Postprandial blood insulin levels
Postprandial insulin responses in blood upon an oral glucose tolerance test
Measured: 45 minutes post-ingestion
Postprandial blood insulin levels
Postprandial insulin responses in blood upon an oral glucose tolerance test
Measured: 60 minutes post-ingestion
Postprandial blood insulin levels
Postprandial insulin responses in blood upon an oral glucose tolerance test
Measured: 90 minutes post-ingestion
Postprandial blood insulin levels
Postprandial insulin responses in blood upon an oral glucose tolerance test
Measured: 120 minutes post-ingestion
Physical activity
Continuous physical activity levels, measured by the Actigraph accelerometer wGT3X-BT (ActiGraph, Pensacola, USA)
Measured: Continuous for 9 weeks
Physical activity
Continuous physical activity levels, measured by ActivPAL3 micro (PAL Technologies, Glasgow, Scotland) during 3 non-consecutive weeks
Measured: Continuous for 3 non-consecutive weeks between week 1 and week 9 of the dietary intervention
Body fat distribution
Ratio between visceral and subcutaneous adipose tissue as measured by magnetic resonance imaging (MRI)
Measured: Baseline
Liver fat content
Liver fat content as measured by MRS
Measured: Baseline
HbA1c
HbA1c
Measured: Baseline
Fasting glucose concentration
Fasting glucose concentration
Measured: Baseline
Fasting insulin concentration
Fasting insulin concentration
Measured: Baseline
Circulating cytokines
Circulating plasma cytokines
Measured: Baseline
PBMC composition
Immune function as measured by PBMC composition
Measured: Baseline
PBMC composition
Immune function as measured by PBMC composition
Measured: End of intervention (week 12)
Metabolism immune cell populations
Metabolism of immune cell populations as measured by SCENITH
Measured: Baseline
Immune function
Metabolism of immune cell populations as measured by SCENITH
Measured: End of intervention (week 12)
Immune response
Immune response upon TLR stimulation
Measured: Baseline
Immune response
Immune response upon TLR stimulation
Measured: End of intervention (week 12)
PBMC cytokine production
PBMC cytokine production as measured by intracellular staining
Measured: Baseline
PBMC cytokine production
PBMC cytokine production as measured by intracellular staining
Measured: End of intervention (week 12)
Oxidative stress marker urine
Oxidative stress as measured by free 8-iso PGF2a in urine
Measured: Baseline
Oxidative stress marker urine
Oxidative stress as measured by free 8-iso PGF2a in urine
Measured: End of intervention (week 12)
Oxidative stress in plasma
Oxidative stress as measured by MDA levels in plasma
Measured: Baseline
Oxidative stress in plasma
Oxidative stress as measured by MDA levels in plasma
Measured: End of intervention (week 12)
Oxidative stress in plasma
Oxidative stress as measured by nitrotyrosine in plasma
Measured: Baseline
Oxidative stress in plasma
Oxidative stress as measured by nitrotyrosine in plasma
Measured: End of intervention (week 12)
Advanced glycation end-products (AGEs) blood
AGE concentrations in plasma as measured by ultraperformance liquid chromatography-tandem mass spectrometry
Measured: Baseline
Advanced glycation end-products (AGEs) blood
AGE concentrations in plasma as measured by ultraperformance liquid chromatography-tandem mass spectrometry
Measured: End of intervention (week 12)
Alpha-dicarbonyl concentrations blood
alpha-dicarbonyl concentrations in plasma as measured by ultraperformance liquid chromatography-tandem mass spectrometry
Measured: Baseline
Alpha-dicarbonyl concentrations blood
alpha-dicarbonyl concentrations in plasma as measured by ultraperformance liquid chromatography-tandem mass spectrometry
Measured: End of intervention (week 12)
AGE accumulation
Accumulation of AGEs in the skin as measured by an AGE reader (Diagnoptics, Groningen, the Netherlands)
Measured: Baseline
AGE accumulation
Accumulation of AGEs in the skin as measured by an AGE reader (Diagnoptics, Groningen, the Netherlands)
Measured: End of intervention (week 12)
Cognitive performance
Cognitive performance as measured by the Cambridge Neuropsychological Test Automated Battery
Measured: Baseline
Oral microbiota composition
Microbiota composition in the saliva by extracting bacterial DNA for 16S rRNA sequencing
Measured: Baseline
Oral microbiota composition
Microbiota composition in the saliva by extracting bacterial DNA for 16S rRNA sequencing
Measured: Week 1 dietary intervention
Oral microbiota composition
Microbiota composition in the saliva by extracting bacterial DNA for 16S rRNA sequencing
Measured: Week 2 dietary intervention
Oral microbiota composition
Microbiota composition in the saliva by extracting bacterial DNA for 16S rRNA sequencing
Measured: Week 3 dietary intervention
Oral microbiota composition
Microbiota composition in the saliva by extracting bacterial DNA for 16S rRNA sequencing
Measured: Week 4 dietary intervention
Oral microbiota composition
Microbiota composition in the saliva by extracting bacterial DNA for 16S rRNA sequencing
Measured: Week 5 dietary intervention
Oral microbiota composition
Microbiota composition in the saliva by extracting bacterial DNA for 16S rRNA sequencing
Measured: Week 6 dietary intervention
Oral microbiota composition
Microbiota composition in the saliva by extracting bacterial DNA for 16S rRNA sequencing
Measured: Week 7 dietary intervention
Oral microbiota composition
Microbiota composition in the saliva by extracting bacterial DNA for 16S rRNA sequencing
Measured: Week 8 dietary intervention
Oral microbiota composition
Microbiota composition in the saliva by extracting bacterial DNA for 16S rRNA sequencing
Measured: Week 9 dietary intervention
Fecal microbiota composition
Microbiota composition in the feces by extracting bacterial DNA for 16S rRNA sequencing
Measured: Baseline
Fecal microbiota composition
Microbiota composition in the feces by extracting bacterial DNA for 16S rRNA sequencing
Measured: Week 1 dietary intervention
Fecal microbiota composition
Microbiota composition in the feces by extracting bacterial DNA for 16S rRNA sequencing
Measured: Week 2 dietary intervention
Fecal microbiota composition
Microbiota composition in the feces by extracting bacterial DNA for 16S rRNA sequencing
Measured: Week 3 dietary intervention
Fecal microbiota composition
Microbiota composition in the feces by extracting bacterial DNA for 16S rRNA sequencing
Measured: Week 4 dietary intervention
Fecal microbiota composition
Microbiota composition in the feces by extracting bacterial DNA for 16S rRNA sequencing
Measured: Week 5 dietary intervention
Fecal microbiota composition
Microbiota composition in the feces by extracting bacterial DNA for 16S rRNA sequencing
Measured: Week 6 dietary intervention
Fecal microbiota composition
Microbiota composition in the feces by extracting bacterial DNA for 16S rRNA sequencing
Measured: Week 7 dietary intervention
Fecal microbiota composition
Microbiota composition in the feces by extracting bacterial DNA for 16S rRNA sequencing
Measured: Week 8 dietary intervention
Fecal microbiota composition
Microbiota composition in the feces by extracting bacterial DNA for 16S rRNA sequencing
Measured: Week 9 dietary intervention
Self-reported stool consistency
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.
Measured: Baseline
Self-reported stool consistency
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.
Measured: Week 1 dietary intervention
Self-reported stool consistency
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.
Measured: Week 2 dietary intervention
Self-reported stool consistency
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.
Measured: Week 3 dietary intervention
Self-reported stool consistency
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.
Measured: Week 4 dietary intervention
Self-reported stool consistency
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.
Measured: Week 5 dietary intervention
Self-reported stool consistency
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.
Measured: Week 6 dietary intervention
Self-reported stool consistency
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.
Measured: Week 7 dietary intervention
Self-reported stool consistency
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.
Measured: Week 8 dietary intervention
Self-reported stool consistency
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.
Measured: Week 9 dietary intervention
Transit time
Transit time, measured as the time in with blue (dietary) dye is consumed and observed in the feces
Measured: Baseline
Transit time
Transit time, measured as the time in with blue (dietary) dye is consumed and observed in the feces
Measured: End of intervention (week 12)
Salivary amylase concentration
Concentration of salivary amylase
Measured: Baseline
Salivary amylase concentration
Concentration of salivary amylase
Measured: End of intervention (week 12)
Salivary amylase activity
Activity of salivary amylase
Measured: Baseline
Salivary amylase activity
Activity of salivary amylase
Measured: End of intervention (week 12)
Genetic variation amylase genes
SNPs in genes coding for amylase, collected using a mouth swab
Measured: Baseline
Genetic variation metabolism and responses to food
SNPs in genes relevant for metabolism and responses to food, collected using a mouth swab
Measured: Baseline
Habitual dietary intake
Habitual dietary intake assessment with a food frequency questionnaire (FFQ)
Measured: Baseline
Plasma glucose response fries A
Plasma glucose response to fries type A
Measured: Baseline
Plasma glucose response fries A
Plasma glucose response to fries type A
Measured: 2 hours post-ingestion
Plasma glucose response fries B
Plasma glucose response to fries type B
Measured: Baseline
Plasma glucose response fries B
Plasma glucose response to fries type B
Measured: 2 hours post-ingestion
Plasma glucose response fries C
Plasma glucose response to fries type C
Measured: Baseline
Plasma glucose response fries C
Plasma glucose response to fries type C
Measured: 2 hours post-ingestion
Plasma glucose response yoghurt A
Plasma glucose response to yoghurt type A
Measured: Baseline
Plasma glucose response yoghurt A
Plasma glucose response to yoghurt type A
Measured: 2 hours post-ingestion
Plasma glucose response yoghurt B
Plasma glucose response to yoghurt type B
Measured: Baseline
Plasma glucose response yoghurt B
Plasma glucose response to yoghurt type B
Measured: 2 hours post-ingestion
Plasma glucose response yoghurt C
Plasma glucose response to yoghurt type C
Measured: Baseline
Plasma glucose response yoghurt C
Plasma glucose response to yoghurt type C
Measured: 2 hours post-ingestion
Plasma glucose response cake A
Plasma glucose response to cake type A
Measured: Baseline
Plasma glucose response cake A
Plasma glucose response to cake type A
Measured: 2 hours post-ingestion
Plasma glucose response cake B
Plasma glucose response to cake type B
Measured: Baseline
Plasma glucose response cake B
Plasma glucose response to cake type B
Measured: 2 hours post-ingestion
Plasma glucose response cake C
Plasma glucose response to cake type C
Measured: Baseline
Plasma glucose response cake C
Plasma glucose response to cake type C
Measured: 2 hours post-ingestion
Plasma insulin response fries A
Plasma insulin response to fries type A
Measured: Baseline
Plasma insulin response fries A
Plasma insulin response to fries type A
Measured: 2 hours post-ingestion
Plasma insulin response fries B
Plasma insulin response to fries type B
Measured: Baseline
Plasma insulin response fries B
Plasma insulin response to fries type B
Measured: 2 hours post-ingestion
Plasma insulin response fries C
Plasma insulin response to fries type C
Measured: Baseline
Plasma insulin response fries C
Plasma insulin response to fries type C
Measured: 2 hours post-ingestion
Plasma insulin response yoghurt A
Plasma insulin response to yoghurt type A
Measured: Baseline
Plasma insulin response yoghurt A
Plasma insulin response to yoghurt type A
Measured: 2 hours post-ingestion
Plasma insulin response yoghurt B
Plasma insulin response to yoghurt type B
Measured: Baseline
Plasma insulin response yoghurt B
Plasma insulin response to yoghurt type B
Measured: 2 hours post-ingestion
Plasma insulin response yoghurt C
Plasma insulin response to yoghurt type C
Measured: Baseline
Plasma insulin response yoghurt C
Plasma insulin response to yoghurt type C
Measured: 2 hours post-ingestion
Plasma insulin response cake A
Plasma insulin response to cake type A
Measured: Baseline
Plasma insulin response cake A
Plasma insulin response to cake type A
Measured: 2 hours post-ingestion
Plasma insulin response cake B
Plasma insulin response to cake type B
Measured: Baseline
Plasma insulin response cake B
Plasma insulin response to cake type B
Measured: 2 hours post-ingestion
Plasma insulin response cake C
Plasma insulin response to cake type C
Measured: Baseline
Plasma insulin response cake C
Plasma insulin response to cake type C
Measured: 2 hours post-ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start26 Aug 2022
- Primary completion13 Dec 2022
- Study completion13 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial Glucose ResponsesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Investigational products will be provided in a standardized environment.
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lydia A. Afman, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456815
- Sponsor's protocol ID
- NL80179.091.21
- Acronym
- RepEAT
- Status last verified
- Jul 2023
- First submitted
- 1 Jul 2022
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The RepEAT Study: Individual Differences in Postprandial Glucose Responses and the Relation With Diet and Phenotype
- ClinicalTrials.gov ID
- NCT05456815
- Acronym / sponsor ID
- RepEAT / NL80179.091.21
- Conditions
- Postprandial Glucose Responses, Glucose Metabolism
- Keywords
- Postprandial, Glucose, Standardized diet, Continuous monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Study start
- 26 Aug 2022 (actual)
- Primary completion
- 13 Dec 2022 (actual)
- Study completion
- 13 Dec 2022 (actual)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Investigational products will be provided in a standardized environment.
| Arm | Type | Receives |
|---|---|---|
| Standardized diet | Other | Other: Standardized dietStandardized food products/meals will be tested |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized dietAlso: 9-week fully controlled dietary interventionDuring 9 weeks all food products will be standardized and provided by the Research Unit. The standardized diet is based on the average food composition in the Netherlands. | Other | Standardized diet |
Primary outcome
Blood glucose profile
Time frame: Continuous for 9 weeks
Interstitial glucose concentrations, as measured by continuous glucose monitoring
165 secondary outcomes
Short-term well-being
Time frame: Baseline
Short-term well-being
Time frame: 1 hour post-ingestion
Short-term well-being
Time frame: 2 hours post-ingestion
Short-term well-being
Time frame: 4 hours post-ingestion
Postprandial glucose blood levels
Time frame: Baseline
Postprandial glucose blood levels
Time frame: 30 minutes post-ingestion
Postprandial glucose blood levels
Time frame: 60 minutes post-ingestion
Postprandial glucose blood levels
Time frame: 90 minutes post-ingestion
Postprandial glucose blood levels
Time frame: 120 minutes post-ingestion
Postprandial glucose blood levels
Time frame: 180 minutes post-ingestion
Postprandial glucose blood levels
Time frame: 240 minutes post-ingestion
Postprandial insulin blood levels
Time frame: Baseline
Postprandial insulin blood levels
Time frame: 30 minutes post-ingestion
Postprandial insulin blood levels
Time frame: 60 minutes post-ingestion
Postprandial insulin blood levels
Time frame: 90 minutes post-ingestion
Postprandial insulin blood levels
Time frame: 120 minutes post-ingestion
Postprandial insulin blood levels
Time frame: 180 minutes post-ingestion
Postprandial insulin blood levels
Time frame: 240 minutes post-ingestion
Postprandial metabolite blood levels
Time frame: Baseline
Postprandial metabolite blood levels
Time frame: 30 minutes post-ingestion
Postprandial metabolite blood levels
Time frame: 60 minutes post-ingestion
Postprandial metabolite blood levels
Time frame: 90 minutes post-ingestion
Postprandial metabolite blood levels
Time frame: 120 minutes post-ingestion
Postprandial metabolite blood levels
Time frame: 180 minutes post-ingestion
Postprandial metabolite blood levels
Time frame: 240 minutes post-ingestion
Postprandial lipid profiling
Time frame: Baseline
Postprandial lipid profiling
Time frame: 30 minutes post-ingestion
Postprandial lipid profiling
Time frame: 60 minutes post-ingestion
Postprandial lipid profiling
Time frame: 90 minutes post-ingestion
Postprandial lipid profiling
Time frame: 120 minutes post-ingestion
Postprandial lipid profiling
Time frame: 180 minutes post-ingestion
Postprandial lipid profiling
Time frame: 240 minutes post-ingestion
Postprandial fatty acid blood levels
Time frame: Baseline
Postprandial fatty acid blood levels
Time frame: 30 minutes post-ingestion
Postprandial fatty acid blood levels
Time frame: 60 minutes post-ingestion
Postprandial fatty acid blood levels
Time frame: 90 minutes post-ingestion
Postprandial fatty acid blood levels
Time frame: 120 minutes post-ingestion
Postprandial fatty acid blood levels
Time frame: 180 minutes post-ingestion
Postprandial fatty acid blood levels
Time frame: 240 minutes post-ingestion
Postprandial gut hormone blood levels
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized diet in people with Postprandial Glucose Responses and Glucose Metabolism, run by Wageningen University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose profile (time frame: Continuous for 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023; AzTrials last refreshed its copy on 27 Oct 2026.