HealthyChroNuNCT04298645
Nutrition Trial on the Glycaemic Response to High GI Meals Consumed at Morning vs. Evening-The ChroNu Study
A study testing Glycaemic response to high GI carbohydrates consumed at morning versus evening meals. in people with Healthy, run by Paderborn University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Glycaemic response to high GI carbohydrates consumed at morning versus evening meals.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 4 Sep 2020to 18 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy students of Paderborn University
- 18 - 25 years old at time of screening for the ChroNu cohort
- 18,5 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Controlled Nutrition Trial on the Glycaemic Response to Morning and Evening Meals With High Glycemic Index Carbohydrates Among Students With Early and Late Chronotypes-The ChroNu Study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Healthy
- Being tested
- Glycaemic response to high GI carbohydrates consumed at morning versus evening meals.
- Keywords
- chronotype, social jetlag, glycaemic response, glycaemic index, continuous glucose monitoring, body composition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: Glycaemic response to high GI carbohydrates consumed at morning versus evening meals. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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 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.
Measured: 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-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.
Measured: 24 hours after test meals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start4 Sep 2020
- Primary completion18 Dec 2020
- Study completion18 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paderborn University
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation, German Diabetes Center, University of Bergen
- Responsible party
- Principal investigator, Anette Buyken, Paderborn University
- Investigators
- Anette E Buyken, Prof. Dr., Principal investigator, Paderborn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298645
- Sponsor's protocol ID
- BU1807/3-2
- Acronym
- ChroNu
- Status last verified
- Dec 2020
- First submitted
- 22 Jan 2020
- Last updated
- 23 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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: * Individual Chronotype (as assessed by the MCTQ) * Individual social jetlag * Anthropometric measurements * Gender * Birth year * meal timing and snacking * intake frequency of stimulants * Duration of being outdoors (contact time to the zeitgeber natural light) * Data on blood samples (lipid metabolism; glucose metabolism; inflammation marker; liver values) * Results for the primary outcome variables by study arm
Publications
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.
PubMed 38605233
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Nutrition Trial on the Glycaemic Response to Morning and Evening Meals With High Glycemic Index Carbohydrates Among Students With Early and Late Chronotypes-The ChroNu Study
- ClinicalTrials.gov ID
- NCT04298645
- Acronym / sponsor ID
- ChroNu / BU1807/3-2
- Conditions
- Healthy
- Keywords
- chronotype, social jetlag, glycaemic response, glycaemic index, continuous glucose monitoring, body composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Paderborn UniversityUniversity, hospital or other
- Collaborators
- German Research Foundation, German Diabetes Center, University of Bergen
- Study start
- 4 Sep 2020 (actual)
- Primary completion
- 18 Dec 2020 (actual)
- Study completion
- 18 Dec 2020 (actual)
- First posted
- 6 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| High GI carbs breakfast / dinner | Experimental | Other: Glycaemic response to high GI carbohydrates consumed at morning versus evening meals.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). |
| High GI carbs dinner / breakfast | Experimental | Other: Glycaemic response to high GI carbohydrates consumed at morning versus evening meals.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). |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy students of Paderborn University
- 18 - 25 years old at time of screening for the ChroNu cohort
- 18,5 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glycaemic response to high GI carbohydrates consumed at morning versus evening meals.Controlled nutrition trial on the glycaemic response to morning and evening meals with high glycemic index carbohydrates among students with early and late chronotypes. | Other | High GI carbs breakfast / dinner, High GI carbs dinner / breakfast |
Primary outcome
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).
Time frame: 2 hour postprandial after test meals
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.
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).
Time frame: 2 hours postprandial after test meals
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 secondary outcomes
Diurnal differences in the glycaemic response (iAUC) and in response to the high GI carbohydrates for dinner and the high GI carbohydrates for breakfast.
Time frame: 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.
Time frame: 24 hours after test meals
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
- Derived from this study: PubMed 38605233Stutz 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.
- Individual participant dataSharing planned: Yes. 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: * Individual Chronotype (as assessed by the MCTQ) * Individual social jetlag * Anthropometric measurements * Gender * Birth year * meal timing and snacking * intake frequency of stimulants * Duration of being outdoors (contact time to the zeitgeber natural light) * Data on blood samples (lipid metabolism; glucose metabolism; inflammation marker; liver values) * Results for the primary outcome variables by study arm
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anette E Buyken, Prof. Dr. principal investigator
Paderborn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glycaemic response to high GI carbohydrates consumed at morning versus evening meals. in people with Healthy, run by Paderborn University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: 2 hour postprandial after test meals). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04298645, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2020.