- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05456815
The RepEAT Study: Individual Differences in Postprandial Glucose Responses and the Relation With Diet and Phenotype (RepEAT)
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
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gelderland
-
Wageningen, Gelderland, Netherlands, 6700 EV
- Wageningen University, Division of Human Nutrition
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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:
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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
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Continuous for 9 weeks
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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
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Short-term well-being upon investigational product consumption assessed by the Multidimensional Mood Questionnaire (MDMQ)
|
1 hour post-ingestion
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Short-term well-being
Time Frame: 2 hours post-ingestion
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Short-term well-being upon investigational product consumption assessed by the Multidimensional Mood Questionnaire (MDMQ)
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2 hours post-ingestion
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Short-term well-being
Time Frame: 4 hours post-ingestion
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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)
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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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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