Glucose Metabolism, Postprandial Glucose Responses
Conditions
Keywords
Postprandial, Glucose, Standardized diet, Continuous monitoring
Brief summary
Postprandial glucose responses are related to an increased risk of developing cardiometabolic diseases. Existing research recognizes the presence of inter-individual variation in postprandial glucose responses to the same meal or food product. However, the role of diet and phenotype in postprandial glucose responses is unclear. The primary objective of this study is to determine the variation in postprandial glucose responses to the same meals/food products and how this relates to the variation in postprandial glucose responses over a 9-week fully controlled dietary intervention within and between individuals. Our secondary objectives are to investigate the difference between postprandial glucose responses to original products and postprandial glucose responses to reformulated products, and to examine the relation between postprandial glucose responses and short-term well-being. In addition, we aim to study the relation between variation in postprandial glucose and phenotype, including immune function, cognitive performance, and microbiota composition. 63 apparently healthy men and women with a BMI of 25-40 kg/m2, aged 45-75 years will be included in the study, comprising a characterization period of 3 weeks and a completely controlled dietary intervention of 9 weeks. During these 9 weeks, glucose will be continuously monitored to measure postprandial glucose responses to standard foods/meals. There are minor risks for the research subjects of this study. Research subjects will invest approximately 85 hours in the study. During the characterization week, subjects will visit the Wageningen University 3 times and Hospital Gelderse Vallei (Ede, The Netherlands) once. During the controlled dietary intervention, subjects will visit the Wageningen University 2-3 times a week.
Detailed description
Postprandial glucose responses are related to an increased risk of developing cardiometabolic diseases. Existing research recognizes the presence of inter-individual variation in postprandial glucose responses to the same meal or food product. However, the role of diet, i.e. the other consumed food products and meals, and phenotype in postprandial glucose responses is unclear. A repetitive design and a standardized diet are necessary to determine the variation in postprandial glucose responses to a meal or food product irrespective of the diet. The primary objective of this study is to determine the variation in postprandial glucose responses to the same meals/food products and how this relates to the variation in postprandial glucose responses over a 9-week fully controlled dietary intervention within and between individuals. Our secondary objectives are to investigate the difference between postprandial glucose responses to original products and postprandial glucose responses to reformulated products, and to examine the relation between postprandial glucose responses and short-term well-being. In addition, we aim to study the relation between variation in postprandial glucose and phenotype, including immune function, cognitive performance, and microbiota composition. The study population consists of 63 apparently healthy men and women with a BMI of 25-40 kg/m2, aged 45-75 years, and who are weight stable (± \<3 kg) for at least three months prior to inclusion. The study comprises a characterization period of three weeks, followed by a fully controlled dietary intervention trial of nine weeks. In the characterization period, the phenotype of participants will be determined by measures on anthropometrics, immune function, oxidative stress, advanced glycation end-products, cognitive performance, microbiota and gut health, amylase, genetics, and circulating metabolites. The dietary intervention consists of three repetitive rounds of three weeks, in which we test food products in a cross-over setting. Participants will consume test products that fall in the same food category, but differ in glycaemic index/carbohydrate content. Part of these products is provided by industrial partners, of which the original products are reformulated to be reduced in glycaemic index/carbohydrate content. During the 9-week dietary intervention all foods are provided, giving us a complete and detailed picture of food and nutrient intake during this period. The standardized diet follows the average consumption pattern of the study population. Throughout the intervention, interstitial glucose concentrations will be measured using continuous glucose monitoring (CGM) and physical activity will be monitored with an accelerometer. This study is related to a broad general population. There are minor risks for the research subjects of this study. Placing a continuous glucose sensor generally does not cause pain, but could result in the loss of a drop of blood, or slight skin irritation after wearing. Blood sampling will be performed via a cannula or venapunction and the insertion can be a bit painful and may cause a bruise. During the characterization period, in total 215 mL of blood will be collected in a 3-week timespan. In the following 9 weeks 108 mL, and at the end of the intervention 34 mL blood will be collected. Research subjects will invest approximately 85 hours in the study. During the characterization week, subjects will visit the Wageningen University 3 times and Hospital Gelderse Vallei (Ede, The Netherlands) once. During the controlled dietary intervention, subjects will visit the Wageningen University 2-3 times a week.
Interventions
OTHERStandardized diet
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.
Sponsors
Wageningen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Masking description
Test products will be provided by the care provider/dietician. All others will be blinded during the trial.
Intervention model description
Investigational products will be provided in a standardized environment.
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood glucose profile | Continuous for 9 weeks | Interstitial glucose concentrations, as measured by continuous glucose monitoring |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short-term well-being | Baseline | Short-term well-being upon investigational product consumption assessed by the Multidimensional Mood Questionnaire (MDMQ) |
| Postprandial glucose blood levels | Baseline | Postprandial glucose responses in blood upon a mixed meal challenge |
| Postprandial insulin blood levels | Baseline | Postprandial insulin responses in blood upon a mixed meal challenge |
| Postprandial metabolite blood levels | Baseline | Postprandial responses in blood upon a mixed meal challenge as measured by metabolomics |
| Postprandial gut hormone blood levels | Baseline | Postprandial gut hormone concentrations in blood upon a mixed meal challenge |
| Postprandial lipid profiling | Baseline | Postprandial lipid profiling in blood upon a mixed meal challenge |
| Postprandial fatty acid blood levels | Baseline | Postprandial fatty acid concentrations in blood upon a mixed meal challenge |
| Cholesterol concentration | Baseline | Fasting plasma cholesterol concentration |
| Postprandial blood glucose levels | Baseline | Postprandial glucose responses in blood upon an oral glucose tolerance test |
| Postprandial blood insulin levels | Baseline | Postprandial insulin responses in blood upon an oral glucose tolerance test |
| Physical activity | Continuous for 9 weeks | Continuous physical activity levels, measured by the Actigraph accelerometer wGT3X-BT (ActiGraph, Pensacola, USA) |
| Body fat distribution | Baseline | Ratio between visceral and subcutaneous adipose tissue as measured by magnetic resonance imaging (MRI) |
| Liver fat content | Baseline | Liver fat content as measured by MRS |
| HbA1c | Baseline | HbA1c |
| Fasting glucose concentration | Baseline | Fasting glucose concentration |
| Fasting insulin concentration | Baseline | Fasting insulin concentration |
| Circulating cytokines | Baseline | Circulating plasma cytokines |
| PBMC composition | Baseline | Immune function as measured by PBMC composition |
| Metabolism immune cell populations | Baseline | Metabolism of immune cell populations as measured by SCENITH |
| Immune function | End of intervention (week 12) | Metabolism of immune cell populations as measured by SCENITH |
| Immune response | Baseline | Immune response upon TLR stimulation |
| PBMC cytokine production | Baseline | PBMC cytokine production as measured by intracellular staining |
| Oxidative stress marker urine | Baseline | Oxidative stress as measured by free 8-iso PGF2a in urine |
| Oxidative stress in plasma | Baseline | Oxidative stress as measured by MDA levels in plasma |
| Advanced glycation end-products (AGEs) blood | Baseline | AGE concentrations in plasma as measured by ultraperformance liquid chromatography-tandem mass spectrometry |
| Alpha-dicarbonyl concentrations blood | Baseline | alpha-dicarbonyl concentrations in plasma as measured by ultraperformance liquid chromatography-tandem mass spectrometry |
| AGE accumulation | Baseline | Accumulation of AGEs in the skin as measured by an AGE reader (Diagnoptics, Groningen, the Netherlands) |
| Cognitive performance | Baseline | Cognitive performance as measured by the Cambridge Neuropsychological Test Automated Battery |
| Oral microbiota composition | Baseline | Microbiota composition in the saliva by extracting bacterial DNA for 16S rRNA sequencing |
| Fecal microbiota composition | Baseline | Microbiota composition in the feces by extracting bacterial DNA for 16S rRNA sequencing |
| Self-reported stool consistency | 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. |
| Transit time | Baseline | Transit time, measured as the time in with blue (dietary) dye is consumed and observed in the feces |
| Salivary amylase concentration | Baseline | Concentration of salivary amylase |
| Salivary amylase activity | Baseline | Activity of salivary amylase |
| Genetic variation amylase genes | Baseline | SNPs in genes coding for amylase, collected using a mouth swab |
| Genetic variation metabolism and responses to food | Baseline | SNPs in genes relevant for metabolism and responses to food, collected using a mouth swab |
| Habitual dietary intake | Baseline | Habitual dietary intake assessment with a food frequency questionnaire (FFQ) |
| Plasma glucose response fries A | Baseline | Plasma glucose response to fries type A |
| Plasma glucose response fries B | Baseline | Plasma glucose response to fries type B |
| Plasma glucose response fries C | Baseline | Plasma glucose response to fries type C |
| Plasma glucose response yoghurt A | Baseline | Plasma glucose response to yoghurt type A |
| Plasma glucose response yoghurt B | Baseline | Plasma glucose response to yoghurt type B |
| Plasma glucose response yoghurt C | Baseline | Plasma glucose response to yoghurt type C |
| Plasma glucose response cake A | Baseline | Plasma glucose response to cake type A |
| Plasma insulin response cake C | Baseline | Plasma insulin response to cake type C |
| Plasma glucose response cake B | Baseline | Plasma glucose response to cake type B |
| Plasma glucose response cake C | Baseline | Plasma glucose response to cake type C |
| Plasma insulin response fries A | Baseline | Plasma insulin response to fries type A |
| Plasma insulin response fries B | Baseline | Plasma insulin response to fries type B |
| Plasma insulin response cake A | Baseline | Plasma insulin response to cake type A |
| Plasma insulin response cake B | Baseline | Plasma insulin response to cake type B |
| Plasma insulin response fries C | Baseline | Plasma insulin response to fries type C |
| Plasma insulin response yoghurt A | Baseline | Plasma insulin response to yoghurt type A |
| Plasma insulin response yoghurt B | Baseline | Plasma insulin response to yoghurt type B |
| Plasma insulin response yoghurt C | Baseline | Plasma insulin response to yoghurt type C |
Other
| Measure | Time frame | Description |
|---|---|---|
| Waist-to-hip ratio | Baseline | Waist-to-hip ratio |
| Body mass index | Baseline | Body mass index |
Countries
Netherlands
Outcome results
None listed