The RepEAT Study: Individual Differences in Postprandial Glucose Responses and the Relation With Diet and Phenotype
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Blood glucose profile
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Test products will be provided by the "care provider"/dietician. All others will be blinded during the trial.
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Standardized diet
Standardized food products/meals will be tested
干预措施: Standardized diet (Other)
结局指标
主要结局
Blood glucose profile
时间窗: Continuous for 9 weeks
Interstitial glucose concentrations, as measured by continuous glucose monitoring
次要结局
- Postprandial glucose blood levels(240 minutes post-ingestion)
- HbA1c(Baseline)
- Immune function(End of intervention (week 12))
- Oxidative stress in plasma(End of intervention (week 12))
- Plasma insulin response fries C(2 hours post-ingestion)
- PBMC cytokine production(End of intervention (week 12))
- Fasting glucose concentration(Baseline)
- Plasma insulin response yoghurt B(2 hours post-ingestion)
- Cholesterol concentration(Baseline)
- Postprandial blood glucose levels(120 minutes post-ingestion)
- Postprandial blood insulin levels(120 minutes post-ingestion)
- Postprandial gut hormone blood levels(240 minutes post-ingestion)
- PBMC composition(End of intervention (week 12))
- Short-term well-being(4 hours post-ingestion)
- Postprandial fatty acid blood levels(240 minutes post-ingestion)
- Physical activity(Continuous for 3 non-consecutive weeks between week 1 and week 9 of the dietary intervention)
- Liver fat content(Baseline)
- Fasting insulin concentration(Baseline)
- Circulating cytokines(Baseline)
- Immune response(End of intervention (week 12))
- Oxidative stress marker urine(End of intervention (week 12))
- Alpha-dicarbonyl concentrations blood(End of intervention (week 12))
- Postprandial insulin blood levels(240 minutes post-ingestion)
- Postprandial metabolite blood levels(240 minutes post-ingestion)
- Postprandial lipid profiling(240 minutes post-ingestion)
- Body fat distribution(Baseline)
- Metabolism immune cell populations(Baseline)
- Advanced glycation end-products (AGEs) blood(End of intervention (week 12))
- Salivary amylase activity(End of intervention (week 12))
- Plasma glucose response fries A(2 hours post-ingestion)
- Plasma glucose response yoghurt B(2 hours post-ingestion)
- Cognitive performance(Baseline)
- Genetic variation metabolism and responses to food(Baseline)
- Plasma glucose response cake B(2 hours post-ingestion)
- Oral microbiota composition(Week 9 dietary intervention)
- Self-reported stool consistency(Week 9 dietary intervention)
- Habitual dietary intake(Baseline)
- Plasma glucose response cake C(2 hours post-ingestion)
- Plasma insulin response fries A(2 hours post-ingestion)
- AGE accumulation(End of intervention (week 12))
- Fecal microbiota composition(Week 9 dietary intervention)
- Transit time(End of intervention (week 12))
- Salivary amylase concentration(End of intervention (week 12))
- Plasma glucose response cake A(2 hours post-ingestion)
- Plasma insulin response fries B(2 hours post-ingestion)
- Plasma insulin response yoghurt A(2 hours post-ingestion)
- Plasma insulin response yoghurt C(2 hours post-ingestion)
- Genetic variation amylase genes(Baseline)
- Plasma glucose response fries B(2 hours post-ingestion)
- Plasma glucose response fries C(2 hours post-ingestion)
- Plasma glucose response yoghurt A(2 hours post-ingestion)
- Plasma glucose response yoghurt C(2 hours post-ingestion)
- Plasma insulin response cake A(2 hours post-ingestion)
- Plasma insulin response cake B(2 hours post-ingestion)
- Plasma insulin response cake C(2 hours post-ingestion)
- Short-term well-being(Baseline)
- Short-term well-being(1 hour post-ingestion)
- Short-term well-being(2 hours post-ingestion)
- Postprandial glucose blood levels(Baseline)
- Postprandial glucose blood levels(30 minutes post-ingestion)
- Immune response(Baseline)
- Postprandial glucose blood levels(60 minutes post-ingestion)
- Postprandial glucose blood levels(90 minutes post-ingestion)
- Postprandial glucose blood levels(120 minutes post-ingestion)
- Postprandial glucose blood levels(180 minutes post-ingestion)
- Postprandial insulin blood levels(Baseline)
- Postprandial insulin blood levels(30 minutes post-ingestion)
- Postprandial insulin blood levels(60 minutes post-ingestion)
- Postprandial insulin blood levels(90 minutes post-ingestion)
- Postprandial insulin blood levels(120 minutes post-ingestion)
- Postprandial insulin blood levels(180 minutes post-ingestion)
- Postprandial metabolite blood levels(Baseline)
- Postprandial metabolite blood levels(30 minutes post-ingestion)
- Postprandial metabolite blood levels(60 minutes post-ingestion)
- Postprandial metabolite blood levels(90 minutes post-ingestion)
- Postprandial metabolite blood levels(120 minutes post-ingestion)
- Plasma glucose response yoghurt A(Baseline)
- Postprandial metabolite blood levels(180 minutes post-ingestion)
- Postprandial lipid profiling(Baseline)
- Postprandial lipid profiling(30 minutes post-ingestion)
- Postprandial lipid profiling(60 minutes post-ingestion)
- Postprandial lipid profiling(90 minutes post-ingestion)
- Postprandial lipid profiling(120 minutes post-ingestion)
- Postprandial lipid profiling(180 minutes post-ingestion)
- Postprandial fatty acid blood levels(Baseline)
- Postprandial fatty acid blood levels(30 minutes post-ingestion)
- Postprandial fatty acid blood levels(60 minutes post-ingestion)
- Postprandial fatty acid blood levels(90 minutes post-ingestion)
- Postprandial fatty acid blood levels(120 minutes post-ingestion)
- Postprandial fatty acid blood levels(180 minutes post-ingestion)
- Postprandial gut hormone blood levels(Baseline)
- Postprandial gut hormone blood levels(30 minutes post-ingestion)
- Postprandial gut hormone blood levels(60 minutes post-ingestion)
- Postprandial gut hormone blood levels(90 minutes post-ingestion)
- Postprandial gut hormone blood levels(120 minutes post-ingestion)
- Postprandial gut hormone blood levels(180 minutes post-ingestion)
- Postprandial blood glucose levels(Baseline)
- Postprandial blood glucose levels(15 minutes post-ingestion)
- Postprandial blood glucose levels(30 minutes post-ingestion)
- Postprandial blood glucose levels(45 minutes post-ingestion)
- Postprandial blood glucose levels(60 minutes post-ingestion)
- Postprandial blood glucose levels(90 minutes post-ingestion)
- Postprandial blood insulin levels(Baseline)
- Postprandial blood insulin levels(15 minutes post-ingestion)
- Postprandial blood insulin levels(30 minutes post-ingestion)
- Postprandial blood insulin levels(45 minutes post-ingestion)
- Postprandial blood insulin levels(60 minutes post-ingestion)
- Postprandial blood insulin levels(90 minutes post-ingestion)
- Physical activity(Continuous for 9 weeks)
- PBMC composition(Baseline)
- PBMC cytokine production(Baseline)
- Oxidative stress marker urine(Baseline)
- Oxidative stress in plasma(Baseline)
- Advanced glycation end-products (AGEs) blood(Baseline)
- Alpha-dicarbonyl concentrations blood(Baseline)
- AGE accumulation(Baseline)
- Oral microbiota composition(Baseline)
- Oral microbiota composition(Week 1 dietary intervention)
- Plasma glucose response yoghurt B(Baseline)
- Oral microbiota composition(Week 2 dietary intervention)
- Oral microbiota composition(Week 3 dietary intervention)
- Oral microbiota composition(Week 4 dietary intervention)
- Plasma glucose response fries A(Baseline)
- Oral microbiota composition(Week 5 dietary intervention)
- Oral microbiota composition(Week 6 dietary intervention)
- Oral microbiota composition(Week 7 dietary intervention)
- Oral microbiota composition(Week 8 dietary intervention)
- Fecal microbiota composition(Baseline)
- Plasma glucose response fries B(Baseline)
- Fecal microbiota composition(Week 1 dietary intervention)
- Fecal microbiota composition(Week 2 dietary intervention)
- Fecal microbiota composition(Week 3 dietary intervention)
- Fecal microbiota composition(Week 4 dietary intervention)
- Fecal microbiota composition(Week 5 dietary intervention)
- Fecal microbiota composition(Week 6 dietary intervention)
- Fecal microbiota composition(Week 7 dietary intervention)
- Fecal microbiota composition(Week 8 dietary intervention)
- Self-reported stool consistency(Baseline)
- Self-reported stool consistency(Week 1 dietary intervention)
- Self-reported stool consistency(Week 2 dietary intervention)
- Plasma glucose response yoghurt C(Baseline)
- Self-reported stool consistency(Week 3 dietary intervention)
- Self-reported stool consistency(Week 4 dietary intervention)
- Self-reported stool consistency(Week 5 dietary intervention)
- Self-reported stool consistency(Week 6 dietary intervention)
- Self-reported stool consistency(Week 7 dietary intervention)
- Self-reported stool consistency(Week 8 dietary intervention)
- Transit time(Baseline)
- Salivary amylase concentration(Baseline)
- Salivary amylase activity(Baseline)
- Plasma glucose response fries C(Baseline)
- Plasma glucose response cake A(Baseline)
- Plasma glucose response cake B(Baseline)
- Plasma glucose response cake C(Baseline)
- Plasma insulin response fries A(Baseline)
- Plasma insulin response fries B(Baseline)
- Plasma insulin response fries C(Baseline)
- Plasma insulin response yoghurt A(Baseline)
- Plasma insulin response yoghurt B(Baseline)
- Plasma insulin response yoghurt C(Baseline)
- Plasma insulin response cake A(Baseline)
- Plasma insulin response cake B(Baseline)
- Plasma insulin response cake C(Baseline)
研究者
Lydia A. Afman
Associate professor
Wageningen University