The RepEAT Study: Individual Differences in Postprandial Glucose Responses and the Relation With Diet and Phenotype (RepEAT)

July 6, 2023 updated by: Lydia A. Afman, Wageningen University

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.

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Gelderland
      • Wageningen, Gelderland, Netherlands, 6700 EV
        • Wageningen University, Division of Human Nutrition

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Standardized diet
Standardized food products/meals will be tested
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.
Other Names:
  • 9-week fully controlled dietary intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood glucose profile
Time Frame: Continuous for 9 weeks
Interstitial glucose concentrations, as measured by continuous glucose monitoring
Continuous for 9 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short-term well-being
Time Frame: Baseline
Short-term well-being upon investigational product consumption assessed by the Multidimensional Mood Questionnaire (MDMQ)
Baseline
Short-term well-being
Time Frame: 1 hour post-ingestion
Short-term well-being upon investigational product consumption assessed by the Multidimensional Mood Questionnaire (MDMQ)
1 hour post-ingestion
Short-term well-being
Time Frame: 2 hours post-ingestion
Short-term well-being upon investigational product consumption assessed by the Multidimensional Mood Questionnaire (MDMQ)
2 hours post-ingestion
Short-term well-being
Time Frame: 4 hours post-ingestion
Short-term well-being upon investigational product consumption assessed by the Multidimensional Mood Questionnaire (MDMQ)
4 hours post-ingestion
Postprandial glucose blood levels
Time Frame: Baseline
Postprandial glucose responses in blood upon a mixed meal challenge
Baseline
Postprandial glucose blood levels
Time Frame: 30 minutes post-ingestion
Postprandial glucose responses in blood upon a mixed meal challenge
30 minutes post-ingestion
Postprandial glucose blood levels
Time Frame: 60 minutes post-ingestion
Postprandial glucose responses in blood upon a mixed meal challenge
60 minutes post-ingestion
Postprandial glucose blood levels
Time Frame: 90 minutes post-ingestion
Postprandial glucose responses in blood upon a mixed meal challenge
90 minutes post-ingestion
Postprandial glucose blood levels
Time Frame: 120 minutes post-ingestion
Postprandial glucose responses in blood upon a mixed meal challenge
120 minutes post-ingestion
Postprandial glucose blood levels
Time Frame: 180 minutes post-ingestion
Postprandial glucose responses in blood upon a mixed meal challenge
180 minutes post-ingestion
Postprandial glucose blood levels
Time Frame: 240 minutes post-ingestion
Postprandial glucose responses in blood upon a mixed meal challenge
240 minutes post-ingestion
Postprandial insulin blood levels
Time Frame: Baseline
Postprandial insulin responses in blood upon a mixed meal challenge
Baseline
Postprandial insulin blood levels
Time Frame: 30 minutes post-ingestion
Postprandial insulin responses in blood upon a mixed meal challenge
30 minutes post-ingestion
Postprandial insulin blood levels
Time Frame: 60 minutes post-ingestion
Postprandial insulin responses in blood upon a mixed meal challenge
60 minutes post-ingestion
Postprandial insulin blood levels
Time Frame: 90 minutes post-ingestion
Postprandial insulin responses in blood upon a mixed meal challenge
90 minutes post-ingestion
Postprandial insulin blood levels
Time Frame: 120 minutes post-ingestion
Postprandial insulin responses in blood upon a mixed meal challenge
120 minutes post-ingestion
Postprandial insulin blood levels
Time Frame: 180 minutes post-ingestion
Postprandial insulin responses in blood upon a mixed meal challenge
180 minutes post-ingestion
Postprandial insulin blood levels
Time Frame: 240 minutes post-ingestion
Postprandial insulin responses in blood upon a mixed meal challenge
240 minutes post-ingestion
Postprandial metabolite blood levels
Time Frame: Baseline
Postprandial responses in blood upon a mixed meal challenge as measured by metabolomics
Baseline
Postprandial metabolite blood levels
Time Frame: 30 minutes post-ingestion
Postprandial responses in blood upon a mixed meal challenge as measured by metabolomics
30 minutes post-ingestion
Postprandial metabolite blood levels
Time Frame: 60 minutes post-ingestion
Postprandial responses in blood upon a mixed meal challenge as measured by metabolomics
60 minutes post-ingestion
Postprandial metabolite blood levels
Time Frame: 90 minutes post-ingestion
Postprandial responses in blood upon a mixed meal challenge as measured by metabolomics
90 minutes post-ingestion
Postprandial metabolite blood levels
Time Frame: 120 minutes post-ingestion
Postprandial responses in blood upon a mixed meal challenge as measured by metabolomics
120 minutes post-ingestion
Postprandial metabolite blood levels
Time Frame: 180 minutes post-ingestion
Postprandial responses in blood upon a mixed meal challenge as measured by metabolomics
180 minutes post-ingestion
Postprandial metabolite blood levels
Time Frame: 240 minutes post-ingestion
Postprandial responses in blood upon a mixed meal challenge as measured by metabolomics
240 minutes post-ingestion
Postprandial lipid profiling
Time Frame: Baseline
Postprandial lipid profiling in blood upon a mixed meal challenge
Baseline
Postprandial lipid profiling
Time Frame: 30 minutes post-ingestion
Postprandial lipid profiling in blood upon a mixed meal challenge
30 minutes post-ingestion
Postprandial lipid profiling
Time Frame: 60 minutes post-ingestion
Postprandial lipid profiling in blood upon a mixed meal challenge
60 minutes post-ingestion
Postprandial lipid profiling
Time Frame: 90 minutes post-ingestion
Postprandial lipid profiling in blood upon a mixed meal challenge
90 minutes post-ingestion
Postprandial lipid profiling
Time Frame: 120 minutes post-ingestion
Postprandial lipid profiling in blood upon a mixed meal challenge
120 minutes post-ingestion
Postprandial lipid profiling
Time Frame: 180 minutes post-ingestion
Postprandial lipid profiling in blood upon a mixed meal challenge
180 minutes post-ingestion
Postprandial lipid profiling
Time Frame: 240 minutes post-ingestion
Postprandial lipid profiling in blood upon a mixed meal challenge
240 minutes post-ingestion
Postprandial fatty acid blood levels
Time Frame: Baseline
Postprandial fatty acid concentrations in blood upon a mixed meal challenge
Baseline
Postprandial fatty acid blood levels
Time Frame: 30 minutes post-ingestion
Postprandial fatty acid concentrations in blood upon a mixed meal challenge
30 minutes post-ingestion
Postprandial fatty acid blood levels
Time Frame: 60 minutes post-ingestion
Postprandial fatty acid concentrations in blood upon a mixed meal challenge
60 minutes post-ingestion
Postprandial fatty acid blood levels
Time Frame: 90 minutes post-ingestion
Postprandial fatty acid concentrations in blood upon a mixed meal challenge
90 minutes post-ingestion
Postprandial fatty acid blood levels
Time Frame: 120 minutes post-ingestion
Postprandial fatty acid concentrations in blood upon a mixed meal challenge
120 minutes post-ingestion
Postprandial fatty acid blood levels
Time Frame: 180 minutes post-ingestion
Postprandial fatty acid concentrations in blood upon a mixed meal challenge
180 minutes post-ingestion
Postprandial fatty acid blood levels
Time Frame: 240 minutes post-ingestion
Postprandial fatty acid concentrations in blood upon a mixed meal challenge
240 minutes post-ingestion
Postprandial gut hormone blood levels
Time Frame: Baseline
Postprandial gut hormone concentrations in blood upon a mixed meal challenge
Baseline
Postprandial gut hormone blood levels
Time Frame: 30 minutes post-ingestion
Postprandial gut hormone concentrations in blood upon a mixed meal challenge
30 minutes post-ingestion
Postprandial gut hormone blood levels
Time Frame: 60 minutes post-ingestion
Postprandial gut hormone concentrations in blood upon a mixed meal challenge
60 minutes post-ingestion
Postprandial gut hormone blood levels
Time Frame: 90 minutes post-ingestion
Postprandial gut hormone concentrations in blood upon a mixed meal challenge
90 minutes post-ingestion
Postprandial gut hormone blood levels
Time Frame: 120 minutes post-ingestion
Postprandial gut hormone concentrations in blood upon a mixed meal challenge
120 minutes post-ingestion
Postprandial gut hormone blood levels
Time Frame: 180 minutes post-ingestion
Postprandial gut hormone concentrations in blood upon a mixed meal challenge
180 minutes post-ingestion
Postprandial gut hormone blood levels
Time Frame: 240 minutes post-ingestion
Postprandial gut hormone concentrations in blood upon a mixed meal challenge
240 minutes post-ingestion
Cholesterol concentration
Time Frame: Baseline
Fasting plasma cholesterol concentration
Baseline
Postprandial blood glucose levels
Time Frame: Baseline
Postprandial glucose responses in blood upon an oral glucose tolerance test
Baseline
Postprandial blood glucose levels
Time Frame: 15 minutes post-ingestion
Postprandial glucose responses in blood upon an oral glucose tolerance test
15 minutes post-ingestion
Postprandial blood glucose levels
Time Frame: 30 minutes post-ingestion
Postprandial glucose responses in blood upon an oral glucose tolerance test
30 minutes post-ingestion
Postprandial blood glucose levels
Time Frame: 45 minutes post-ingestion
Postprandial glucose responses in blood upon an oral glucose tolerance test
45 minutes post-ingestion
Postprandial blood glucose levels
Time Frame: 60 minutes post-ingestion
Postprandial glucose responses in blood upon an oral glucose tolerance test
60 minutes post-ingestion
Postprandial blood glucose levels
Time Frame: 90 minutes post-ingestion
Postprandial glucose responses in blood upon an oral glucose tolerance test
90 minutes post-ingestion
Postprandial blood glucose levels
Time Frame: 120 minutes post-ingestion
Postprandial glucose responses in blood upon an oral glucose tolerance test
120 minutes post-ingestion
Postprandial blood insulin levels
Time Frame: Baseline
Postprandial insulin responses in blood upon an oral glucose tolerance test
Baseline
Postprandial blood insulin levels
Time Frame: 15 minutes post-ingestion
Postprandial insulin responses in blood upon an oral glucose tolerance test
15 minutes post-ingestion
Postprandial blood insulin levels
Time Frame: 30 minutes post-ingestion
Postprandial insulin responses in blood upon an oral glucose tolerance test
30 minutes post-ingestion
Postprandial blood insulin levels
Time Frame: 45 minutes post-ingestion
Postprandial insulin responses in blood upon an oral glucose tolerance test
45 minutes post-ingestion
Postprandial blood insulin levels
Time Frame: 60 minutes post-ingestion
Postprandial insulin responses in blood upon an oral glucose tolerance test
60 minutes post-ingestion
Postprandial blood insulin levels
Time Frame: 90 minutes post-ingestion
Postprandial insulin responses in blood upon an oral glucose tolerance test
90 minutes post-ingestion
Postprandial blood insulin levels
Time Frame: 120 minutes post-ingestion
Postprandial insulin responses in blood upon an oral glucose tolerance test
120 minutes post-ingestion
Physical activity
Time Frame: Continuous for 9 weeks
Continuous physical activity levels, measured by the Actigraph accelerometer wGT3X-BT (ActiGraph, Pensacola, USA)
Continuous for 9 weeks
Physical activity
Time Frame: 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
Continuous for 3 non-consecutive weeks between week 1 and week 9 of the dietary intervention
Body fat distribution
Time Frame: Baseline
Ratio between visceral and subcutaneous adipose tissue as measured by magnetic resonance imaging (MRI)
Baseline
Liver fat content
Time Frame: Baseline
Liver fat content as measured by MRS
Baseline
HbA1c
Time Frame: Baseline
HbA1c
Baseline
Fasting glucose concentration
Time Frame: Baseline
Fasting glucose concentration
Baseline
Fasting insulin concentration
Time Frame: Baseline
Fasting insulin concentration
Baseline
Circulating cytokines
Time Frame: Baseline
Circulating plasma cytokines
Baseline
PBMC composition
Time Frame: Baseline
Immune function as measured by PBMC composition
Baseline
PBMC composition
Time Frame: End of intervention (week 12)
Immune function as measured by PBMC composition
End of intervention (week 12)
Metabolism immune cell populations
Time Frame: Baseline
Metabolism of immune cell populations as measured by SCENITH
Baseline
Immune function
Time Frame: End of intervention (week 12)
Metabolism of immune cell populations as measured by SCENITH
End of intervention (week 12)
Immune response
Time Frame: Baseline
Immune response upon TLR stimulation
Baseline
Immune response
Time Frame: End of intervention (week 12)
Immune response upon TLR stimulation
End of intervention (week 12)
PBMC cytokine production
Time Frame: Baseline
PBMC cytokine production as measured by intracellular staining
Baseline
PBMC cytokine production
Time Frame: End of intervention (week 12)
PBMC cytokine production as measured by intracellular staining
End of intervention (week 12)
Oxidative stress marker urine
Time Frame: Baseline
Oxidative stress as measured by free 8-iso PGF2a in urine
Baseline
Oxidative stress marker urine
Time Frame: End of intervention (week 12)
Oxidative stress as measured by free 8-iso PGF2a in urine
End of intervention (week 12)
Oxidative stress in plasma
Time Frame: Baseline
Oxidative stress as measured by MDA levels in plasma
Baseline
Oxidative stress in plasma
Time Frame: End of intervention (week 12)
Oxidative stress as measured by MDA levels in plasma
End of intervention (week 12)
Oxidative stress in plasma
Time Frame: Baseline
Oxidative stress as measured by nitrotyrosine in plasma
Baseline
Oxidative stress in plasma
Time Frame: End of intervention (week 12)
Oxidative stress as measured by nitrotyrosine in plasma
End of intervention (week 12)
Advanced glycation end-products (AGEs) blood
Time Frame: Baseline
AGE concentrations in plasma as measured by ultraperformance liquid chromatography-tandem mass spectrometry
Baseline
Advanced glycation end-products (AGEs) blood
Time Frame: End of intervention (week 12)
AGE concentrations in plasma as measured by ultraperformance liquid chromatography-tandem mass spectrometry
End of intervention (week 12)
Alpha-dicarbonyl concentrations blood
Time Frame: Baseline
alpha-dicarbonyl concentrations in plasma as measured by ultraperformance liquid chromatography-tandem mass spectrometry
Baseline
Alpha-dicarbonyl concentrations blood
Time Frame: End of intervention (week 12)
alpha-dicarbonyl concentrations in plasma as measured by ultraperformance liquid chromatography-tandem mass spectrometry
End of intervention (week 12)
AGE accumulation
Time Frame: Baseline
Accumulation of AGEs in the skin as measured by an AGE reader (Diagnoptics, Groningen, the Netherlands)
Baseline
AGE accumulation
Time Frame: End of intervention (week 12)
Accumulation of AGEs in the skin as measured by an AGE reader (Diagnoptics, Groningen, the Netherlands)
End of intervention (week 12)
Cognitive performance
Time Frame: Baseline
Cognitive performance as measured by the Cambridge Neuropsychological Test Automated Battery
Baseline
Oral microbiota composition
Time Frame: Baseline
Microbiota composition in the saliva by extracting bacterial DNA for 16S rRNA sequencing
Baseline
Oral microbiota composition
Time Frame: Week 1 dietary intervention
Microbiota composition in the saliva by extracting bacterial DNA for 16S rRNA sequencing
Week 1 dietary intervention
Oral microbiota composition
Time Frame: Week 2 dietary intervention
Microbiota composition in the saliva by extracting bacterial DNA for 16S rRNA sequencing
Week 2 dietary intervention
Oral microbiota composition
Time Frame: Week 3 dietary intervention
Microbiota composition in the saliva by extracting bacterial DNA for 16S rRNA sequencing
Week 3 dietary intervention
Oral microbiota composition
Time Frame: Week 4 dietary intervention
Microbiota composition in the saliva by extracting bacterial DNA for 16S rRNA sequencing
Week 4 dietary intervention
Oral microbiota composition
Time Frame: Week 5 dietary intervention
Microbiota composition in the saliva by extracting bacterial DNA for 16S rRNA sequencing
Week 5 dietary intervention
Oral microbiota composition
Time Frame: Week 6 dietary intervention
Microbiota composition in the saliva by extracting bacterial DNA for 16S rRNA sequencing
Week 6 dietary intervention
Oral microbiota composition
Time Frame: Week 7 dietary intervention
Microbiota composition in the saliva by extracting bacterial DNA for 16S rRNA sequencing
Week 7 dietary intervention
Oral microbiota composition
Time Frame: Week 8 dietary intervention
Microbiota composition in the saliva by extracting bacterial DNA for 16S rRNA sequencing
Week 8 dietary intervention
Oral microbiota composition
Time Frame: Week 9 dietary intervention
Microbiota composition in the saliva by extracting bacterial DNA for 16S rRNA sequencing
Week 9 dietary intervention
Fecal microbiota composition
Time Frame: Baseline
Microbiota composition in the feces by extracting bacterial DNA for 16S rRNA sequencing
Baseline
Fecal microbiota composition
Time Frame: Week 1 dietary intervention
Microbiota composition in the feces by extracting bacterial DNA for 16S rRNA sequencing
Week 1 dietary intervention
Fecal microbiota composition
Time Frame: Week 2 dietary intervention
Microbiota composition in the feces by extracting bacterial DNA for 16S rRNA sequencing
Week 2 dietary intervention
Fecal microbiota composition
Time Frame: Week 3 dietary intervention
Microbiota composition in the feces by extracting bacterial DNA for 16S rRNA sequencing
Week 3 dietary intervention
Fecal microbiota composition
Time Frame: Week 4 dietary intervention
Microbiota composition in the feces by extracting bacterial DNA for 16S rRNA sequencing
Week 4 dietary intervention
Fecal microbiota composition
Time Frame: Week 5 dietary intervention
Microbiota composition in the feces by extracting bacterial DNA for 16S rRNA sequencing
Week 5 dietary intervention
Fecal microbiota composition
Time Frame: Week 6 dietary intervention
Microbiota composition in the feces by extracting bacterial DNA for 16S rRNA sequencing
Week 6 dietary intervention
Fecal microbiota composition
Time Frame: Week 7 dietary intervention
Microbiota composition in the feces by extracting bacterial DNA for 16S rRNA sequencing
Week 7 dietary intervention
Fecal microbiota composition
Time Frame: Week 8 dietary intervention
Microbiota composition in the feces by extracting bacterial DNA for 16S rRNA sequencing
Week 8 dietary intervention
Fecal microbiota composition
Time Frame: Week 9 dietary intervention
Microbiota composition in the feces by extracting bacterial DNA for 16S rRNA sequencing
Week 9 dietary intervention
Self-reported stool consistency
Time Frame: Baseline
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.
Baseline
Self-reported stool consistency
Time Frame: Week 1 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.
Week 1 dietary intervention
Self-reported stool consistency
Time Frame: Week 2 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.
Week 2 dietary intervention
Self-reported stool consistency
Time Frame: Week 3 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.
Week 3 dietary intervention
Self-reported stool consistency
Time Frame: Week 4 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.
Week 4 dietary intervention
Self-reported stool consistency
Time Frame: Week 5 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.
Week 5 dietary intervention
Self-reported stool consistency
Time Frame: Week 6 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.
Week 6 dietary intervention
Self-reported stool consistency
Time Frame: Week 7 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.
Week 7 dietary intervention
Self-reported stool consistency
Time Frame: Week 8 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.
Week 8 dietary intervention
Self-reported stool consistency
Time Frame: 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.
Week 9 dietary intervention
Transit time
Time Frame: Baseline
Transit time, measured as the time in with blue (dietary) dye is consumed and observed in the feces
Baseline
Transit time
Time Frame: End of intervention (week 12)
Transit time, measured as the time in with blue (dietary) dye is consumed and observed in the feces
End of intervention (week 12)
Salivary amylase concentration
Time Frame: Baseline
Concentration of salivary amylase
Baseline
Salivary amylase concentration
Time Frame: End of intervention (week 12)
Concentration of salivary amylase
End of intervention (week 12)
Salivary amylase activity
Time Frame: Baseline
Activity of salivary amylase
Baseline
Salivary amylase activity
Time Frame: End of intervention (week 12)
Activity of salivary amylase
End of intervention (week 12)
Genetic variation amylase genes
Time Frame: Baseline
SNPs in genes coding for amylase, collected using a mouth swab
Baseline
Genetic variation metabolism and responses to food
Time Frame: Baseline
SNPs in genes relevant for metabolism and responses to food, collected using a mouth swab
Baseline
Habitual dietary intake
Time Frame: Baseline
Habitual dietary intake assessment with a food frequency questionnaire (FFQ)
Baseline
Plasma glucose response fries A
Time Frame: Baseline
Plasma glucose response to fries type A
Baseline
Plasma glucose response fries A
Time Frame: 2 hours post-ingestion
Plasma glucose response to fries type A
2 hours post-ingestion
Plasma glucose response fries B
Time Frame: Baseline
Plasma glucose response to fries type B
Baseline
Plasma glucose response fries B
Time Frame: 2 hours post-ingestion
Plasma glucose response to fries type B
2 hours post-ingestion
Plasma glucose response fries C
Time Frame: Baseline
Plasma glucose response to fries type C
Baseline
Plasma glucose response fries C
Time Frame: 2 hours post-ingestion
Plasma glucose response to fries type C
2 hours post-ingestion
Plasma glucose response yoghurt A
Time Frame: Baseline
Plasma glucose response to yoghurt type A
Baseline
Plasma glucose response yoghurt A
Time Frame: 2 hours post-ingestion
Plasma glucose response to yoghurt type A
2 hours post-ingestion
Plasma glucose response yoghurt B
Time Frame: Baseline
Plasma glucose response to yoghurt type B
Baseline
Plasma glucose response yoghurt B
Time Frame: 2 hours post-ingestion
Plasma glucose response to yoghurt type B
2 hours post-ingestion
Plasma glucose response yoghurt C
Time Frame: Baseline
Plasma glucose response to yoghurt type C
Baseline
Plasma glucose response yoghurt C
Time Frame: 2 hours post-ingestion
Plasma glucose response to yoghurt type C
2 hours post-ingestion
Plasma glucose response cake A
Time Frame: Baseline
Plasma glucose response to cake type A
Baseline
Plasma glucose response cake A
Time Frame: 2 hours post-ingestion
Plasma glucose response to cake type A
2 hours post-ingestion
Plasma glucose response cake B
Time Frame: Baseline
Plasma glucose response to cake type B
Baseline
Plasma glucose response cake B
Time Frame: 2 hours post-ingestion
Plasma glucose response to cake type B
2 hours post-ingestion
Plasma glucose response cake C
Time Frame: Baseline
Plasma glucose response to cake type C
Baseline
Plasma glucose response cake C
Time Frame: 2 hours post-ingestion
Plasma glucose response to cake type C
2 hours post-ingestion
Plasma insulin response fries A
Time Frame: Baseline
Plasma insulin response to fries type A
Baseline
Plasma insulin response fries A
Time Frame: 2 hours post-ingestion
Plasma insulin response to fries type A
2 hours post-ingestion
Plasma insulin response fries B
Time Frame: Baseline
Plasma insulin response to fries type B
Baseline
Plasma insulin response fries B
Time Frame: 2 hours post-ingestion
Plasma insulin response to fries type B
2 hours post-ingestion
Plasma insulin response fries C
Time Frame: Baseline
Plasma insulin response to fries type C
Baseline
Plasma insulin response fries C
Time Frame: 2 hours post-ingestion
Plasma insulin response to fries type C
2 hours post-ingestion
Plasma insulin response yoghurt A
Time Frame: Baseline
Plasma insulin response to yoghurt type A
Baseline
Plasma insulin response yoghurt A
Time Frame: 2 hours post-ingestion
Plasma insulin response to yoghurt type A
2 hours post-ingestion
Plasma insulin response yoghurt B
Time Frame: Baseline
Plasma insulin response to yoghurt type B
Baseline
Plasma insulin response yoghurt B
Time Frame: 2 hours post-ingestion
Plasma insulin response to yoghurt type B
2 hours post-ingestion
Plasma insulin response yoghurt C
Time Frame: Baseline
Plasma insulin response to yoghurt type C
Baseline
Plasma insulin response yoghurt C
Time Frame: 2 hours post-ingestion
Plasma insulin response to yoghurt type C
2 hours post-ingestion
Plasma insulin response cake A
Time Frame: Baseline
Plasma insulin response to cake type A
Baseline
Plasma insulin response cake A
Time Frame: 2 hours post-ingestion
Plasma insulin response to cake type A
2 hours post-ingestion
Plasma insulin response cake B
Time Frame: Baseline
Plasma insulin response to cake type B
Baseline
Plasma insulin response cake B
Time Frame: 2 hours post-ingestion
Plasma insulin response to cake type B
2 hours post-ingestion
Plasma insulin response cake C
Time Frame: Baseline
Plasma insulin response to cake type C
Baseline
Plasma insulin response cake C
Time Frame: 2 hours post-ingestion
Plasma insulin response to cake type C
2 hours post-ingestion

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Waist-to-hip ratio
Time Frame: Baseline
Waist-to-hip ratio
Baseline
Body mass index
Time Frame: Baseline
Body mass index
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2022

Primary Completion (Actual)

December 13, 2022

Study Completion (Actual)

December 13, 2022

Study Registration Dates

First Submitted

July 1, 2022

First Submitted That Met QC Criteria

July 9, 2022

First Posted (Actual)

July 13, 2022

Study Record Updates

Last Update Posted (Actual)

July 10, 2023

Last Update Submitted That Met QC Criteria

July 6, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • NL80179.091.21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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