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| Name | Class |
|---|---|
| German Research Foundation | OTHER |
| German Diabetes Center | OTHER |
| University of Bergen | OTHER |
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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.
To address the hypothesis that dietary misalignment among young adults has detrimental short-term effects on glucose metabolism, participants will consume a meal rich in high GI carbohydrates on two separate days either at breakfast (7:00) or at dinner (20:00). Glycaemic responses will be monitored by a continuous glucose monitoring device (CGM) (G6, Dexcom, Inc., San Diego, CA). The CGM electrochemically measures subcutaneous interstitial glucose concentrations of each participant during the whole study. A blood glucose meter will be used to verify the functionality of the CGM (CONTOUR®NEXT ONE).
The caloric content of the meals will be tailored to the energy needs of the participants based on their age, sex and anthropometric measurements. Participants will be requested to consume the meals without any break. During the controlled nutrition trial, participants will be asked to abstain from alcohol consumption and heavy exercise and not consume any food in addition to that provided or drinks that should be explicitly avoided.
To objectively corroborate their chronotype participants will be asked to wear an accelerometer (E4 wristband, Empatica) attached to the wrist during the controlled nutrition trial. Moreover, participants are asked to record their bed times, meal timings, daily routines, and physical activities during the trial. On day 1 and day 8, anthropometric measurements will be performed to compare the body composition (Bioimpedance Analysis, SECA mBCA) before and after the controlled nutrition trial. On day 4, fasting blood samples will be collected. Before the controlled nutrition trial will start, questionnaires on daily routines, food frequency, and chronotype will be carried out.
The chronotype is defined as mid-sleep point and assessed by the Munich Chronotype Questionnaire, which is a validated questionnaire. Earlier and later chronotypes will be defined as 20% of the participants with each the earliest and later mid-sleep points among the participants of the ChroNu cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 hour post prandial response (iAUC) is calculated as the incremental area under the curve of measurements taken within the 24 hours after the test meals. | 24 hours after test meals |
| Measure | Description | Time Frame |
|---|---|---|
| Blood lipids, inflammation marker, and glucose homeostasis | Blood lipids, markers of chronic inflammation, and glucose homeostasis will be measured from serum or plasma obtained from fasting whole blood samples.
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anette E Buyken, Prof. Dr. | Paderborn University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paderborn University | Paderborn | North Rhine-Westphalia | 33098 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38605233 | Derived | 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. |
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In the University of Bergen (Department of Clinical Medicine, Center for Nutrition) explorative analyses will be performed so as to determine whether individuals with an early and late chronotype differ in their clock genes. Additional analyses may be performed to explore whether the clock genes are relevant for the effects of the intervention on the primary outcomes among both persons with early and late chronotypes. To this end they will be provided with pseudonymized data on:
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.
Pseudonymized data will be delivered personally to the University of Bergen. Requests on data will be reviewed by Mrs. Buyken,head of the study.
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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.
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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.
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| Diurnal differences in the glycaemic variability (MAGE) in response to the high GI carbohydrates for dinner and the high GI carbohydrates for breakfast. |
24-h pp glycaemic variability (MAGE) is calculated as the mean amplitude of glycaemic excursions during the 24 hours after the test meals, i.e. both resemble summary measures calculated from repeated measurements taken the 24 h pp. |
| 24 hours after test meals |
| 7:30 on run-in day |
| Insulin level | - fasting plasma insulin level (µE/mL) | 7:30 run-in day |
| Liver enzymes |
| 7:30 run-in day |
| Clock gene expression | 7:30 run-in day |
| Sleep timing | Sleep timing (unit) will be determined using an accelerometer (Empatica E4) and manually kept diary during the 8 days of nutrition trial. This information will serve to to corroborate the chronotype of the participants. | 8 days |
| Change in fat mass | Body composition is electronically analyzed using Bioimpedance Analysis (BIA) (mBCA 515, SECA). | at baseline (day 1) and after intervention (day 8) |
| Change in Body Mass Index | Body Mass Index (BMI) is calculated by weight(kg) / height(m)²). Weight and height are measured electronically. | at baseline (day 1) and after intervention (day 8) |