Cardiovascular Risk Factor Clinical Trial
Official title:
The Effects of Four Weeks of Intermittent Fasting on Resting Energy Expenditure, Satiety Hormones, Body Composition, and Performance in Competitive Runners
Verified date | March 2020 |
Source | USDA, Western Human Nutrition Research Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a cross-over intervention study designed to evaluate how four weeks of time restricted feeding (16 hours fasting and 8 hours feeding), compared to four weeks of a more traditional eating pattern (12 hours fasting and 12 hours feeding), affects resting energy expenditure, subjective and biochemical markers of satiety and hunger, body composition, cardiovascular health, substrate utilization and fitness in male competitive runners.
Status | Completed |
Enrollment | 21 |
Est. completion date | March 24, 2020 |
Est. primary completion date | March 24, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 20 Years to 40 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | UC Davis, Western Human Nutrition Research Center | Davis | California |
Lead Sponsor | Collaborator |
---|---|
USDA, Western Human Nutrition Research Center | University of California, Davis |
United States,
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Moro T, Tinsley G, Bianco A, Marcolin G, Pacelli QF, Battaglia G, Palma A, Gentil P, Neri M, Paoli A. Effects of eight weeks of time-restricted feeding (16/8) on basal metabolism, maximal strength, body composition, inflammation, and cardiovascular risk factors in resistance-trained males. J Transl Med. 2016 Oct 13;14(1):290. — View Citation
Patterson RE, Sears DD. Metabolic Effects of Intermittent Fasting. Annu Rev Nutr. 2017 Aug 21;37:371-393. doi: 10.1146/annurev-nutr-071816-064634. Epub 2017 Jul 17. Review. — View Citation
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Tinsley GM, Forsse JS, Butler NK, Paoli A, Bane AA, La Bounty PM, Morgan GB, Grandjean PW. Time-restricted feeding in young men performing resistance training: A randomized controlled trial. Eur J Sport Sci. 2017 Mar;17(2):200-207. doi: 10.1080/17461391.2016.1223173. Epub 2016 Aug 22. — View Citation
Tinsley GM, La Bounty PM. Effects of intermittent fasting on body composition and clinical health markers in humans. Nutr Rev. 2015 Oct;73(10):661-74. doi: 10.1093/nutrit/nuv041. Epub 2015 Sep 15. Review. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in resting energy expenditure | Resting energy expenditure will be measured using a metabolic cart | Study day 1, 28, 43 and 70 | |
Secondary | Change in body composition | Body composition, including fat mass and lean body mass, will be measured by dual-energy x-ray absorptiometry (DEXA) and expressed in kilograms (kg). | Study day 1, 28, 43 and 70 | |
Secondary | Change in substrate utilization during exercise | Carbohydrate and fat utilized for energy will be measured using a metabolic cart | Study day 1, 28, 43 and 70 | |
Secondary | Change in cardiovascular fitness | Time to run a 10 kilometer time trial on a treadmill expressed in minutes | Study day 1, 28, 43 and 70 | |
Secondary | Change in perceived feelings of hunger and fullness | 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." | Study day 1, 28, 43 and 70 | |
Secondary | Change in glucagon, a biomarker of hunger and satiety | Fasting plasma will be analyzed for glucagon (pmol/L) as measured by enzyme-linked immunoabsorbant assay | Study day 1, 28, 43 and 70 | |
Secondary | Change in leptin, a biomarker of hunger and satiety | Fasting plasma will be analyzed for leptin (pmol/L) as measured by enzyme-linked immunoabsorbant assay | Study day 1, 28, 43 and 70 | |
Secondary | Change in ghrelin, a biomarker of hunger and satiety | Fasting plasma will be analyzed for ghrelin (pmol/L) as measured by enzyme-linked immunoabsorbant assay | Study day 1, 28, 43 and 70 | |
Secondary | Change in insulin | Fasting plasma will be analyzed for insulin (pmol/L) as measured by enzyme-linked immunoabsorbant assay | Study day 1, 28, 43 and 70 | |
Secondary | Change in total cholesterol, a biomarker of cardiovascular health | Fasting serum will be analyzed for total cholesterol (mmol/L) by Piccolo analyzer | Study day 1, 28, 43 and 70 | |
Secondary | Change in HDL cholesterol, a biomarker of cardiovascular health | Fasting serum will be analyzed for HDL cholesterol (mmol/L) by Piccolo analyzer | Study day 1, 28, 43 and 70 | |
Secondary | Change in LDL cholesterol, a biomarker of cardiovascular health | Fasting serum will be analyzed for LDL cholesterol (mmol/L) by Piccolo analyzer | Study day 1, 28, 43 and 70 | |
Secondary | Change in very low-density lipoprotein (VLDL), a biomarker of cardiovascular health | Fasting serum will be analyzed for very low-density lipoprotein (VLDL) cholesterol (mmol/L) by Piccolo analyzer | Study day 1, 28, 43 and 70 | |
Secondary | Change in triglycerides, a biomarker of cardiovascular health | Fasting serum will be analyzed for triglycerides (mmol/L) by Piccolo analyzer | Study day 1, 28, 43 and 70 | |
Secondary | Change in alanine aminotransferase, a biomarker of cardiovascular health | Fasting serum will be analyzed for alanine aminotransferase (IU/L) by Piccolo analyzer | Study day 1, 28, 43 and 70 | |
Secondary | Change in aspartate aminotransferase, a biomarker of cardiovascular health | Fasting serum will be analyzed for aspartate aminotransferase (IU/L) by Piccolo analyzer | Study day 1, 28, 43 and 70 | |
Secondary | Change in glucose | Fasting serum will be analyzed for glucose (mmol/L) by Piccolo analyzer | Study day 1, 28, 43 and 70 |
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