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

NCT05456815 | Completed

• 1 other identifier: NL80179.091.21
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Postprandial Glucose Responses; Glucose Metabolism

Keywords

Postprandial; Glucose; Standardized diet; Continuous monitoring

Outcome Measures

Primary Outcomes (1)

• Blood glucose profile

  Interstitial glucose concentrations, as measured by continuous glucose monitoring

  Continuous for 9 weeks

Secondary Outcomes (165)

• Short-term well-being

  Baseline

• Short-term well-being

  1 hour post-ingestion

• Short-term well-being

  2 hours post-ingestion

• Short-term well-being

  4 hours post-ingestion

• Postprandial glucose blood levels

  Baseline

Other Outcomes (2)

• Waist-to-hip ratio

  Baseline

• Body mass index

  Baseline

Study Arms (1)

Standardized diet

OTHER

Standardized food products/meals will be tested

Other: Standardized diet

Interventions

Standardized diet OTHER

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.

Also known as: 9-week fully controlled dietary intervention

Standardized diet

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Apparently healthy men and women
• BMI of 25 - 40 kg/m2
• Age 45-75 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Wageningen University: lead

Study Sites (1)

Wageningen University, Division of Human Nutrition

Wageningen, Gelderland, 6700 EV, Netherlands

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Test products will be provided by the "care provider"/dietician. All others will be blinded during the trial.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Investigational products will be provided in a standardized environment.

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 13, 2022
• Study Start: August 26, 2022
• Primary Completion: December 13, 2022
• Study Completion: December 13, 2022
• Last Updated: July 10, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)