Time Restricted Feeding in Male Runners
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ClinicalTrials.gov Identifier: NCT03569852 |
Recruitment Status :
Completed
First Posted : June 26, 2018
Last Update Posted : April 1, 2020
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Condition or disease | Intervention/treatment | Phase |
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Fasting Intermittent Fasting Athletic Performance Cardiovascular Risk Factor Resting Energy Expenditure | Behavioral: Time Restrictive Feeding Behavioral: Traditional Eating Pattern | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 21 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | The Effects of Four Weeks of Intermittent Fasting on Resting Energy Expenditure, Satiety Hormones, Body Composition, and Performance in Competitive Runners |
Actual Study Start Date : | July 15, 2018 |
Actual Primary Completion Date : | March 24, 2020 |
Actual Study Completion Date : | March 24, 2020 |
Arm | Intervention/treatment |
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Experimental: Experimental Group 1
Order of treatment, time restrictive feeding (16 hours fasting and 8 hours eating) followed by traditional eating pattern (12 hours fasted and 12 hours eating).
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Behavioral: Time Restrictive Feeding
Volunteers will adhere to a form of time restrictive feeding, 16 hours fasting and 8 hours eating per day.
Other Name: Intermittent Fasting Behavioral: Traditional Eating Pattern Volunteers will adhere to a more traditional eating pattern, 12 hours fasted and 12 hours eating per day.
Other Name: Normal Diet |
Experimental: Experimental Group 2
Order of treatment, traditional eating pattern (12 hours fasted and 12 hours eating) followed by time restrictive feeding (16 hours fasting and 8 hours eating).
|
Behavioral: Time Restrictive Feeding
Volunteers will adhere to a form of time restrictive feeding, 16 hours fasting and 8 hours eating per day.
Other Name: Intermittent Fasting Behavioral: Traditional Eating Pattern Volunteers will adhere to a more traditional eating pattern, 12 hours fasted and 12 hours eating per day.
Other Name: Normal Diet |
- Change in resting energy expenditure [ Time Frame: Study day 1, 28, 43 and 70 ]Resting energy expenditure will be measured using a metabolic cart
- Change in body composition [ Time Frame: Study day 1, 28, 43 and 70 ]Body composition, including fat mass and lean body mass, will be measured by dual-energy x-ray absorptiometry (DEXA) and expressed in kilograms (kg).
- Change in substrate utilization during exercise [ Time Frame: Study day 1, 28, 43 and 70 ]Carbohydrate and fat utilized for energy will be measured using a metabolic cart
- Change in cardiovascular fitness [ Time Frame: Study day 1, 28, 43 and 70 ]Time to run a 10 kilometer time trial on a treadmill expressed in minutes
- Change in perceived feelings of hunger and fullness [ Time Frame: Study day 1, 28, 43 and 70 ]Perceived hunger and fullness will be measured using a visual analog scale. Responses will be a mark on an unsegmented line from 0 or "not at all" to 5 or "extremely."
- Change in glucagon, a biomarker of hunger and satiety [ Time Frame: Study day 1, 28, 43 and 70 ]Fasting plasma will be analyzed for glucagon (pmol/L) as measured by enzyme-linked immunoabsorbant assay
- Change in leptin, a biomarker of hunger and satiety [ Time Frame: Study day 1, 28, 43 and 70 ]Fasting plasma will be analyzed for leptin (pmol/L) as measured by enzyme-linked immunoabsorbant assay
- Change in ghrelin, a biomarker of hunger and satiety [ Time Frame: Study day 1, 28, 43 and 70 ]Fasting plasma will be analyzed for ghrelin (pmol/L) as measured by enzyme-linked immunoabsorbant assay
- Change in insulin [ Time Frame: Study day 1, 28, 43 and 70 ]Fasting plasma will be analyzed for insulin (pmol/L) as measured by enzyme-linked immunoabsorbant assay
- Change in total cholesterol, a biomarker of cardiovascular health [ Time Frame: Study day 1, 28, 43 and 70 ]Fasting serum will be analyzed for total cholesterol (mmol/L) by Piccolo analyzer
- Change in HDL cholesterol, a biomarker of cardiovascular health [ Time Frame: Study day 1, 28, 43 and 70 ]Fasting serum will be analyzed for HDL cholesterol (mmol/L) by Piccolo analyzer
- Change in LDL cholesterol, a biomarker of cardiovascular health [ Time Frame: Study day 1, 28, 43 and 70 ]Fasting serum will be analyzed for LDL cholesterol (mmol/L) by Piccolo analyzer
- Change in very low-density lipoprotein (VLDL), a biomarker of cardiovascular health [ Time Frame: Study day 1, 28, 43 and 70 ]Fasting serum will be analyzed for very low-density lipoprotein (VLDL) cholesterol (mmol/L) by Piccolo analyzer
- Change in triglycerides, a biomarker of cardiovascular health [ Time Frame: Study day 1, 28, 43 and 70 ]Fasting serum will be analyzed for triglycerides (mmol/L) by Piccolo analyzer
- Change in alanine aminotransferase, a biomarker of cardiovascular health [ Time Frame: Study day 1, 28, 43 and 70 ]Fasting serum will be analyzed for alanine aminotransferase (IU/L) by Piccolo analyzer
- Change in aspartate aminotransferase, a biomarker of cardiovascular health [ Time Frame: Study day 1, 28, 43 and 70 ]Fasting serum will be analyzed for aspartate aminotransferase (IU/L) by Piccolo analyzer
- Change in glucose [ Time Frame: Study day 1, 28, 43 and 70 ]Fasting serum will be analyzed for glucose (mmol/L) by Piccolo analyzer

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Ages Eligible for Study: | 20 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Competitive runners who have been actively training for 3 or more years
- Weigh a minimum of 110 lbs
- Training 4-6 times per week and run a minimum of 20 miles per week
- Competed in a race within past 12 months at a distance of 5 - 26.1 km
- Willing to repeat same monthly training protocol during two 4-week interventions
- VO2max range of 40-70 ml/kg/min
Exclusion Criteria:
- Smoker
- Take medications that have cardiovascular or metabolic effects
- Taking dietary supplements
- Following a restrictive diet including restricting calories or carbohydrates
- Evidence of an eating disorder
- Major injuries in past 3 months
- Chronic disease that affects bone health, metabolism or the cardiorespiratory system
- Present with any contra-indication to exercise testing (cardiovascular abnormalities) as evaluated by study physician

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03569852
United States, California | |
UC Davis, Western Human Nutrition Research Center | |
Davis, California, United States, 95616 |
Principal Investigator: | Gretchen Casazza, PhD | University of California, Davis |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | USDA, Western Human Nutrition Research Center |
ClinicalTrials.gov Identifier: | NCT03569852 |
Other Study ID Numbers: |
TRF 1223350 |
First Posted: | June 26, 2018 Key Record Dates |
Last Update Posted: | April 1, 2020 |
Last Verified: | March 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |