- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07434349
Exercise Timing and Postprandial Glucose Responses (ExTime-Glu)
Exercise Timing and Postprandial Glucose Responses in Healthy Adults
This interventional crossover study examines the effect of exercise timing relative to meal intake on postprandial glucose responses in healthy, physically active young adults. Participants complete five experimental conditions involving endurance exercise performed before or after breakfast or dinner, as well as a non-exercise control condition, while wearing a continuous glucose monitoring device.
Postprandial glucose responses are assessed for the three consecutive meals following each exercise session. Following morning exercise, outcomes are assessed after breakfast, lunch, and dinner on the same day. Following evening exercise, outcomes are assessed after dinner on the same day and after breakfast and lunch on the subsequent day. All meals are standardized and consumed at fixed clock times.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is conducted as a repeated measures, randomized crossover trial. Each participant completes five intervention conditions within a 14 day study period while wearing a continuous glucose monitoring device. The order of conditions is randomized, and all participants complete all conditions.
The five conditions include endurance exercise performed before breakfast, after breakfast, before dinner, after dinner, and a recovery day without exercise. On exercise days, participants complete a 45 minute outdoor run at a vigorous intensity at predefined times relative to standardized meals. Breakfast, lunch, and dinner are consumed at fixed clock times (08:00, 13:00, and 18:00, respectively).
Postprandial glucose outcomes are assessed for the three consecutive meals following each exercise session. In conditions involving exercise performed before or after breakfast, outcomes are assessed following breakfast, lunch, and dinner on the same day. In conditions involving exercise performed before or after dinner, outcomes are assessed following dinner on the same day and following breakfast and lunch on the subsequent day.
Dietary intake is fully standardized across all intervention days. Meal composition is identical across intervention days within participants, with macronutrient composition held constant. Meals are designed to have a high glycemic load, calculated using published glycemic index tables and established food composition databases. Meals must be consumed within a predefined consumption window, with the start of meal intake serving as the reference time point for postprandial glucose analyses. Adherence to meal timing and consumption is verified using time-stamped photographs of meals and packaging, along with a standardized checklist documenting consumption times.
Habitual waking times compatible with the fixed breakfast time are required for study participation. During the intervention period, participants are instructed to standardize bedtime as closely as possible across study days and to record wake time and sleep duration daily by self-report. Caffeine consumption is restricted on intervention days and on the day preceding each intervention day. On the day before each intervention day, participants are also instructed to refrain from structured exercise and alcohol. Participants are further instructed to replicate, as closely as possible, the type and timing of meals consumed on the day preceding each intervention condition in order to standardize pre-intervention nutritional status. This applies particularly to the day before conditions involving morning exercise and to earlier meals consumed on days with evening exercise.
All exercise sessions are completed outdoors on the same route. Ambient temperature and precipitation are recorded for each exercise session using smartphone-based weather data. Exercise sessions may be rescheduled in cases of extreme weather conditions or acute illness to ensure participant safety and protocol consistency.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Christoph Höchsmann, PD Dr.
- Phone Number: +49 89 289 24488
- Email: christoph.hoechsmann@tum.de
Study Contact Backup
- Name: Karsten Köhler, Prof. Dr.
- Email: karsten.koehler@tum.de
Study Locations
-
-
Bavaria
-
München, Bavaria, Germany, 80809
- Recruiting
- Technical University of Munich
-
Contact:
- Christoph Höchsmann, PD Dr.
- Phone Number: +49 89 289 24488
- Email: christoph.hoechsmann@tum.de
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18 to 35 years
- Body mass index 18.5 to 24.9 kg per square meter
- Able to complete 45 minutes of continuous running at an intensity corresponding to 75 to 85 percent of maximal heart rate without stopping
- Engages in regular endurance-type physical activity
- Habitual waking times are compatible with the fixed breakfast time of 08:00
- Willing and able to comply with all study procedures, including standardized meals, exercise sessions, behavioral restrictions, and continuous glucose monitoring
- For female participants: non-pregnant and using stable hormonal contraception for at least 3 months
Exclusion Criteria:
- Acute or chronic illness
- Metabolic disorders or conditions associated with altered glucose or lipid metabolism
- Use of medications known to interfere with glucose metabolism or study outcomes
- Intolerance or allergy to components of the standardized study diets
- Pregnancy or breastfeeding
- Body mass index greater than or equal to 25 kg per square meter
- Current or past eating disorder, or any medical condition or medication that could affect appetite regulation, glucose regulation, or make vigorous endurance exercise unsafe
- Current smoking or use of nicotine-containing products
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Run Before Breakfast
Participants complete a 45 minute outdoor run beginning 60 minutes before the standardized breakfast time (08:00).
A short recovery period is allowed between completion of exercise and meal initiation.
Postprandial glucose responses are assessed following breakfast, lunch (13:00), and dinner (18:00).
|
The exercise intervention consists of a 45 minute continuous outdoor run performed on a standardized route. Participants are instructed to maintain a consistent running pace across all exercise conditions. Exercise intensity is standardized using a target heart rate corresponding to 75 to 85 percent of maximal heart rate, and participants must be able to complete 45 minutes of continuous running at this intensity without stopping. Heart rate, duration, distance, and pace are recorded using a heart rate monitor and GPS enabled device. Ambient temperature and precipitation are recorded for each session. Exercise sessions may be rescheduled in cases of extreme weather or acute illness. |
|
Experimental: Run After Breakfast
Participants complete a 45 minute outdoor run beginning 90 minutes after the start of breakfast (08:00).
Postprandial glucose responses are assessed following breakfast, lunch (13:00), and dinner (18:00).
|
The exercise intervention consists of a 45 minute continuous outdoor run performed on a standardized route. Participants are instructed to maintain a consistent running pace across all exercise conditions. Exercise intensity is standardized using a target heart rate corresponding to 75 to 85 percent of maximal heart rate, and participants must be able to complete 45 minutes of continuous running at this intensity without stopping. Heart rate, duration, distance, and pace are recorded using a heart rate monitor and GPS enabled device. Ambient temperature and precipitation are recorded for each session. Exercise sessions may be rescheduled in cases of extreme weather or acute illness. |
|
Experimental: Run Before Dinner
Participants complete a 45 minute outdoor run beginning 60 minutes before the standardized dinner time (18:00).
Postprandial glucose responses are assessed following dinner on the same day and following breakfast (08:00) and lunch (13:00) on the subsequent day.
|
The exercise intervention consists of a 45 minute continuous outdoor run performed on a standardized route. Participants are instructed to maintain a consistent running pace across all exercise conditions. Exercise intensity is standardized using a target heart rate corresponding to 75 to 85 percent of maximal heart rate, and participants must be able to complete 45 minutes of continuous running at this intensity without stopping. Heart rate, duration, distance, and pace are recorded using a heart rate monitor and GPS enabled device. Ambient temperature and precipitation are recorded for each session. Exercise sessions may be rescheduled in cases of extreme weather or acute illness. |
|
Experimental: Run After Dinner
Participants complete a 45 minute outdoor run beginning 90 minutes after the start of dinner (18:00).
Postprandial glucose responses are assessed following dinner on the same day and following breakfast (08:00) and lunch (13:00) on the subsequent day.
|
The exercise intervention consists of a 45 minute continuous outdoor run performed on a standardized route. Participants are instructed to maintain a consistent running pace across all exercise conditions. Exercise intensity is standardized using a target heart rate corresponding to 75 to 85 percent of maximal heart rate, and participants must be able to complete 45 minutes of continuous running at this intensity without stopping. Heart rate, duration, distance, and pace are recorded using a heart rate monitor and GPS enabled device. Ambient temperature and precipitation are recorded for each session. Exercise sessions may be rescheduled in cases of extreme weather or acute illness. |
|
Experimental: No Exercise Control
Participants do not perform structured exercise on this study day and follow the standardized meal schedule.
This condition serves as a within participant control.
Postprandial glucose responses are assessed following breakfast (08:00), lunch (13:00), and dinner (18:00).
|
This intervention involves a non-exercise control condition
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
3-hour postprandial glucose area under the curve (AUC)
Time Frame: During each intervention condition within the 14-day study period, assessed over the 3-hour period following each of the three consecutive meals after each condition
|
The area under the curve for interstitial glucose concentration during the 3-hour period following each of the three consecutive meals assessed after each exercise or control condition, measured using continuous glucose monitoring.
|
During each intervention condition within the 14-day study period, assessed over the 3-hour period following each of the three consecutive meals after each condition
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incremental postprandial glucose AUC
Time Frame: During each intervention condition within the 14-day study period, assessed over the 3-hour period following each of the three consecutive meals after each condition
|
Incremental area under the curve for interstitial glucose concentration during the 3-hour postprandial period following each assessed meal, calculated relative to pre-meal baseline glucose concentration.
|
During each intervention condition within the 14-day study period, assessed over the 3-hour period following each of the three consecutive meals after each condition
|
|
Peak postprandial glucose concentration
Time Frame: During each intervention condition within the 14-day study period, assessed over the 3-hour period following each of the three consecutive meals after each condition
|
Maximum interstitial glucose concentration following each meal.
|
During each intervention condition within the 14-day study period, assessed over the 3-hour period following each of the three consecutive meals after each condition
|
|
Time to peak glucose
Time Frame: During each intervention condition within the 14-day study period, assessed over the 3-hour period following each of the three consecutive meals after each condition
|
Time from meal initiation to peak interstitial glucose concentration.
|
During each intervention condition within the 14-day study period, assessed over the 3-hour period following each of the three consecutive meals after each condition
|
|
Subjective appetite ratings
Time Frame: Repeatedly during each intervention condition within the 14-day study period, assessed before and after each meal and exercise session
|
Subjective sensations of hunger, fullness, prospective food consumption, desire to eat, nausea, and thirst are assessed using electronic 100-mm visual analog scales administered before and after each meal and each exercise session.
|
Repeatedly during each intervention condition within the 14-day study period, assessed before and after each meal and exercise session
|
|
Rating of perceived exertion
Time Frame: Immediately after each exercise session during each intervention condition within the 14-day study period
|
Perceived exertion following each exercise session is assessed using the Borg Rating of Perceived Exertion scale (6-20).
|
Immediately after each exercise session during each intervention condition within the 14-day study period
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christoph Höchsmann, PD Dr., Technical University of Munich
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ExTime-Glu
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postprandial Glucose
-
Purdue UniversityNot yet recruitingPostprandial Metabolism | Insulin Response | Postprandial Glucose Response | Lactose Digestion
-
Lund UniversitySwedish Foundation for Strategic ResearchCompleted
-
Wageningen UniversityCompletedGlucose Metabolism | Postprandial Glucose ResponsesNetherlands
-
NestléCompletedPostprandial Glucose ResponseSwitzerland
-
Lund UniversitySwedish Foundation for Strategic ResearchCompleted
-
San Diego State UniversityCompletedPostprandial Blood GlucoseUnited States
-
Glycemic Index Laboratories, IncCanadian Center for Functional Medicine; InovoBiologic Inc.CompletedBlood Glucose, PostprandialCanada
-
Harokopio UniversityCompletedPostprandial Glucose RegulationGreece
-
Lund UniversitySwedish Foundation for Strategic ResearchCompleted
-
Marjukka KolehmainenCompletedHyperglycemia | Blood Glucose, Postprandial | Blood Insulin, PostprandialFinland
Clinical Trials on Timed Endurance Exercise
-
University of Illinois at Urbana-ChampaignNational Heart, Lung, and Blood Institute (NHLBI)CompletedVascular Health | Autonomic FunctionUnited States
-
University of TorontoCompleted
-
Riphah International UniversityCompleted
-
Norwegian University of Science and TechnologyLHL-Klinikkene, Røros; LHL-Klinikkene, FeiringWithdrawnVentricular Dysfunction, Left | Heart Failure, DiastolicNorway
-
University of LisbonFundação para a Ciência e a TecnologiaActive, not recruiting
-
Comenius UniversityUniversity of Roma La Sapienza; University of Primorska; University of Padova; Physiko-...Recruiting
-
University Hospital Inselspital, BerneFederal Office of Sports, SwitzerlandCompletedMyocardial Ischemia | Heart Failure | Exercise | Myocardial Stunning | Myocardial ContractionSwitzerland
-
Rigshospitalet, DenmarkCompleted
-
Charite University, Berlin, GermanyUnknown
-
Landsteiner InstitutLund University; Medical University of Vienna; Mein Hanusch-Krankenhaus; Fondazione... and other collaboratorsCompletedType 2 Diabetes Mellitus | Insulin ResistanceAustria