Technical University of Munich
München, Bavaria, 80809, Germany
Location status: Recruiting
NCT Number: NCT07434349
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.
Interested in participating?
Request Info18 year–35 year
All sexes
Interventional
Not applicable
München, Bavaria, 80809, Germany
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
This intervention involves a non-exercise control condition
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.
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.
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.
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.
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.
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).
Contact information is provided by the study sponsor or research team.
Christoph Höchsmann, PD Dr.
CONTACT
Karsten Köhler, Prof. Dr.
CONTACT
Technical University of Munich
Other
Exercise Timing and Postprandial Glucose Responses in Healthy Adults
Acronym: ExTime-Glu
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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