- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06947824
Time-of-Day Effects of Fasted Exercise on Energy Intake
Effects of Fasted Morning vs. Evening Exercise on Post-Exercise Energy Intake
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bavaria
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Munich, Bavaria, Germany, 80809
- Technical University of Munich
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- BMI of 18.5.0-30.0 kg/m2
- weight stability (≤2.5 kg weight change during the past 3 months)
- ability to exercise at a vigorous intensity for 30 minutes
Exclusion Criteria:
- pregnancy or breastfeeding
- smoking
- history of or current eating disorders
- medical condition or use of medication that could affect appetite or pose any contraindications to exercise
As the menstrual cycle can cause fluctuations in food cravings and appetite, women of childbearing age were only eligible if they used hormonal contraceptives. To ensure constant exposure to exogenous estrogen and progestin throughout the study phase, participating women were further asked to use active hormone pills throughout the study period in both studies, a practice that is considered both safe and efficacious.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Fasted Morning Exercise (12h AMEx)
Exercise will take place in the morning, following a 12h overnight fast
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A 30-minute exercise session will take place on a treadmill in the morning (7:00, ~1h after participants' habitual wake-up time), after a 12h overnight fast.
The session will consist of 30 minutes of steady state cycling at 65% of VO2max, following a 5 min warm-up.
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Active Comparator: Fasted Evening Exercise (6h PMEx)
Exercise will take place in the evening, following a 6h period of fasting
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A 30-minute exercise session will take place on a treadmill in the evening (19:00, exactly 12 hours after the morning session), after a 6h fasting period.
The session will consist of 30 minutes of steady state cycling at 65% of VO2max, following a 5 min warm-up.
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Active Comparator: Fasted Evening Exercise (12h PMEx)
Exercise will take place in the evening, following a 12h period of fasting
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A 30-minute exercise session will take place on a treadmill in the evening (19:00, exactly 12 hours after the morning session), after a 12h fasting period.
The session will consist of 30 minutes of steady state cycling at 65% of VO2max, following a 5 min warm-up.
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Active Comparator: Fed Morning Exercise (AMEx Fed)
Exercise will take place in the morning after consuming a small snack (30 min before exercise)
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A 30-minute exercise session will take place on a treadmill in the morning (7:00, ~1h after participants' habitual wake-up time), after consuming a small pre-exercise snack (30 min before exercise).
The session will consist of 30 minutes of steady state cycling at 65% of VO2max, following a 5 min warm-up.
|
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Active Comparator: Fed Evening Exercise (PMEx Fed)
Exercise will take place in the evening after consuming a small snack (30 min before exercise)
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A 30-minute exercise session will take place on a treadmill in the evening (19:00, exactly 12 hours after the morning session), after consuming a small pre-exercise snack (30 min before exercise).
The session will consist of 30 minutes of steady state cycling at 65% of VO2max, following a 5 min warm-up.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Acute ad-libitum post-exercise energy intake (test meal)
Time Frame: 30 minutes after exercise
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Acute post-exercise energy intake (kcal) will be measured objectively using a single-item ad libitum test meal occurring 30 minutes after each exercise session.
The meal will consist of cheese pizza, offered in excess of individual daily energy requirements, and all food will be provided at once.
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30 minutes after exercise
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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24h post-exercise energy intake
Time Frame: 24 hours post-exercise
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Post-exercise energy intake (ad libitum) will be self-reported (weighed food log) during the 24 hours following the exercise session.
For the 6h PMEx and 12h PMEx conditions, this will encompass all food consumed after the exercise session until 19:00 the next day, including the test meal and typically the next day's breakfast, lunch, dinner, and all snacks consumed during this period.
For the 12h AMEx condition, the 24-hour post-exercise period will encompass the test meal and typically lunch, dinner, snacks on the day of exercise, and the next day's breakfast, with the observation period ending at 07:00.
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24 hours post-exercise
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Carbohydrate oxidation
Time Frame: continuously throughout the 30-minute exercise bout
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Carbohydrate oxidation, measured via indirect calorimetry
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continuously throughout the 30-minute exercise bout
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Fat oxidation
Time Frame: continuously throughout the 30-minute exercise bout
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Fat oxidation, measured via indirect calorimetry
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continuously throughout the 30-minute exercise bout
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Energy expenditure
Time Frame: continuously throughout the 30-minute exercise bout
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Energy expenditure, measured via indirect calorimetry
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continuously throughout the 30-minute exercise bout
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Subjective appetite measures
Time Frame: before exercise, immediately after exercise, and 30 minutes after exercise
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At each study condition visit, participants will rate their subjective perception of hunger, fullness, and desire to eat, and prospective food consumption on a 100mm visual analog scale anchored from "not at all" to "extremely" before each exercise session (Pre), immediately after (Post), and after an additional 30 minutes of post-exercise rest (Post30, immediately before the test meal),
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before exercise, immediately after exercise, and 30 minutes after exercise
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Blood glucose
Time Frame: before exercise and immediately after exercise
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Blood glucose measured via capillary blodd (finger prick)
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before exercise and immediately after exercise
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Blood lactate
Time Frame: before exercise and immediately after exercise
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measurement via capillary blood from the ear lobe
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before exercise and immediately after exercise
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Breath ketones
Time Frame: before and immediately after exercise
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breath analysis via Lumen (MetaFlow Ltd) device
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before and immediately after exercise
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Blood ketones
Time Frame: before exercise and immediately after exercise
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measured via capillary blood (finger prick) and Freestyle Precision Neo (Abbott).
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before exercise and immediately after exercise
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- MvE_FastEx
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.
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