Nutrition Trial on the Glycaemic Response to High GI Meals Consumed at Morning vs. Evening-The ChroNu Study

NCT04298645 | Completed DMC

• 1 other identifier: BU1807/3-2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Several studies suggest that meal timing plays an important role in the development of obesity and metabolic diseases. Especially in the evening, a high consumption of carbohydrates, which greatly increase blood glucose levels (i.e. unfavourable carbohydrates with a higher glycaemic index (GI)), has been found to adversely affect glycaemic response. However, avoidance of (unfavourable) carbohydrate consumption appears to be particularly problematic for young adults due to its interference with the timing of social life and their chronotype. The chronotype describes individual differences in sleep timing on free days and is most delayed around the age of 20. Young adults are thus prone to be exposed to a dietary misalignment when socially determined schedules, such as early lectures at universities, collide with their biologically determined later chronotype. Therefore, it is hypothesized that dietary misalignment among young adults has detrimental short-term effects on the glucose metabolism. In this nutrition trial, dietary misalignment is induced by providing the same meal rich in carbohydrates with a high glycaemic index (GI) on two separate days at different times: breakfast at 7:00 is assumed to reflect a schedule potentially inducing dietary misalignment among later chronotypes. Vice versa, providing this meal at dinner (20:00) may cause dietary misalignment among earlier chronotypes. Adverse glycaemic responses are expected when the high GI meal is consumed at a time which is deviating from the schedule of the individual chronotype. A regular increase in postprandial glycaemia due to constant dietary misalignment may be important in the development of metabolic diseases.

Conditions

Healthy

Keywords

chronotype; social jetlag; glycaemic response; glycaemic index; continuous glucose monitoring; body composition

Outcome Measures

Primary Outcomes (2)

• Differences in the 2-h pp glycaemic response between the high GI carbohydrate meal consumed for breakfast (7:00) and the high GI carbohydrate meal consumed for dinner (20:00).

  2 hour post prandial response (iAUC) is calculated as the incremental area under the curve of measurements taken within the two hours after the test meals.

  2 hour postprandial after test meals

• Differences in the 2-h pp glycaemic variability between the high GI carbohydrate meal consumed for breakfast (7:00) and the high GI carbohydrate meal consumed for dinner (20:00).

  the 2-h pp glycaemic variability (MAGE) is calculated as the mean amplitude of glycaemic excursions during the two hours after the test meals, i.e. both resemble summary measures calculated from repeated measurements taken the 2 h pp.

  2 hours postprandial after test meals

Secondary Outcomes (2)

• Diurnal differences in the glycaemic response (iAUC) and in response to the high GI carbohydrates for dinner and the high GI carbohydrates for breakfast.

  24 hours after test meals

• Diurnal differences in the glycaemic variability (MAGE) in response to the high GI carbohydrates for dinner and the high GI carbohydrates for breakfast.

  24 hours after test meals

Other Outcomes (7)

• Blood lipids, inflammation marker, and glucose homeostasis

  7:30 on run-in day

• Insulin level

  7:30 run-in day

• Liver enzymes

  7:30 run-in day

Study Arms (2)

High GI carbs breakfast / dinner

EXPERIMENTAL

Participants will receive a meal rich in high GI carbohydrates for breakfast (day 5) first. After the wash-out day (day 6), the identical meal will be provided for dinner (day 7).

Other: Glycaemic response to high GI carbohydrates consumed at morning versus evening meals.

High GI carbs dinner / breakfast

EXPERIMENTAL

Participants will receive a meal rich in high GI carbohydrates for dinner (day 5) first. After the wash-out day (day 6), the same meal will be provided for breakfast (day 7).

Other: Glycaemic response to high GI carbohydrates consumed at morning versus evening meals.

Interventions

Glycaemic response to high GI carbohydrates consumed at morning versus evening meals. OTHER

Controlled nutrition trial on the glycaemic response to morning and evening meals with high glycemic index carbohydrates among students with early and late chronotypes.

High GI carbs breakfast / dinner; High GI carbs dinner / breakfast

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy students of Paderborn University
• years old at time of screening for the ChroNu cohort
• ,5 kg/m² \< BMI \> 30 kg/m²
• Free of diseases requiring constant or chronic medical treatment (except for oral contraceptives)
• Willingness to participate in the nutrition trial (8 days) including invasive measurements
• Fluent knowledge of the German language

You may not qualify if:

• students studying nutrition science at the University Paderborn
• regular smokers
• pregnancy or lactation
• chronic diseases: diabetes mellitus (all types), pre-diabetes, individuals with bleeding disorders (thrombocytopenia, haemophilia)
• contact dermatitis to adhesive plaster or skin disease that prevents the participant from wearing the CGM
• intake of medication which influence the chronotype: such as antidepressants or sleeping pills
• shift work in the past 3 months
• crossing of \> 1-time zone in the past 3 months
• strict vegetarians /vegans
• individuals having an allergy or intolerance to food that is included in the diet

Sponsors & Collaborators

• Paderborn University: lead
• German Research Foundation: collaborator
• German Diabetes Center: collaborator
• University of Bergen: collaborator

Study Sites (1)

Paderborn University

Paderborn, North Rhine-Westphalia, 33098, Germany

Location

Related Publications (1)

• Stutz B, Krueger B, Goletzke J, Jankovic N, Alexy U, Herder C, Dierkes J, Berg-Beckhoff G, Jakobsmeyer R, Reinsberger C, Buyken AE. Glycemic response to meals with a high glycemic index differs between morning and evening: a randomized cross-over controlled trial among students with early or late chronotype. Eur J Nutr. 2024 Aug;63(5):1593-1604. doi: 10.1007/s00394-024-03372-4. Epub 2024 Apr 12.

  PMID: 38605233 DERIVED

Study Officials

• Anette E Buyken, Prof. Dr.

  Paderborn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking to the study arm is not possible for participants since the study involves consumption of "real food" to which the participants cannot be blinded. Similarly, the researchers cannot be blinded to the food provided to the participants.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Anette Buyken, Public Health Nutrition

Model Details: 60 participants will be invited of which 20 participants with an earlier and 20 participants with a later chronotype are expected to finish the study. Participants will consume a meal rich in carbohydrates with a high GI on two separate days at different times. Hence, participants are randomly assigned to one group stratified by chronotype: intake of a meal with a high GI on day 5 either in the morning or in the evening. On day 7, meal timing of the high GI meal is switched. Following a 3 - day observational part on "free days", the controlled nutrition trial will last 4 days: run - in (day 4), high GI meal for breakfast/dinner (days 5 / 7), and wash - out (day 6). The trial is a two-arm cross-over study in which each participant serves as his / her own control to account for inter-individual variations in diurnal glycaemic responses.

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: March 6, 2020
• Study Start: September 4, 2020
• Primary Completion: December 18, 2020
• Study Completion: December 18, 2020
• Last Updated: December 23, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Blood samples collected in TempusTM Blood RNA tubes will be collectively sent to Bergen when all samples are taken from the participants which will be September 2020 at the latest. Pseudonymized data will shared as long as need for the explorative analyses, which will be done in 2022.
• Access Criteria: Pseudonymized data will be delivered personally to the University of Bergen. Requests on data will be reviewed by Mrs. Buyken,head of the study.

Locations

DE (1)