NCT03569852

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 26, 2018

Completed
19 days until next milestone

Study Start

First participant enrolled

July 15, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2020

Completed
Last Updated

April 1, 2020

Status Verified

March 1, 2020

Enrollment Period

1.7 years

First QC Date

June 15, 2018

Last Update Submit

March 30, 2020

Conditions

FastingIntermittent FastingAthletic PerformanceCardiovascular Risk FactorResting Energy Expenditure

Outcome Measures

Primary Outcomes (1)

  • Change in resting energy expenditure

    Resting energy expenditure will be measured using a metabolic cart

    Study day 1, 28, 43 and 70

Secondary Outcomes (16)

  • Change in body composition

    Study day 1, 28, 43 and 70

  • Change in substrate utilization during exercise

    Study day 1, 28, 43 and 70

  • Change in cardiovascular fitness

    Study day 1, 28, 43 and 70

  • Change in perceived feelings of hunger and fullness

    Study day 1, 28, 43 and 70

  • Change in glucagon, a biomarker of hunger and satiety

    Study day 1, 28, 43 and 70

  • +11 more secondary outcomes

Study Arms (2)

Experimental Group 1

EXPERIMENTAL

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).

Behavioral: Time Restrictive FeedingBehavioral: Traditional Eating Pattern

Experimental Group 2

EXPERIMENTAL

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 FeedingBehavioral: Traditional Eating Pattern

Interventions

Time Restrictive FeedingBEHAVIORAL

Volunteers will adhere to a form of time restrictive feeding, 16 hours fasting and 8 hours eating per day.

Also known as: Intermittent Fasting
Experimental Group 1Experimental Group 2
Traditional Eating PatternBEHAVIORAL

Volunteers will adhere to a more traditional eating pattern, 12 hours fasted and 12 hours eating per day.

Also known as: Normal Diet
Experimental Group 1Experimental Group 2

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis, Western Human Nutrition Research Center

Davis, California, 95616, United States

Location

Related Publications (10)

  • Maughan RJ, Fallah J, Coyle EF. The effects of fasting on metabolism and performance. Br J Sports Med. 2010 Jun;44(7):490-4. doi: 10.1136/bjsm.2010.072181. Epub 2010 May 19.

    PMID: 20484315BACKGROUND

  • 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.

    PMID: 28715993BACKGROUND

  • Roy AS, Bandyopadhyay A. Effect of Ramadan intermittent fasting on selective fitness profile parameters in young untrained Muslim men. BMJ Open Sport Exerc Med. 2015 Sep 30;1(1):e000020. doi: 10.1136/bmjsem-2015-000020. eCollection 2015.

    PMID: 27900122BACKGROUND

  • 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.

    PMID: 26374764BACKGROUND

  • Klempel MC, Kroeger CM, Bhutani S, Trepanowski JF, Varady KA. Intermittent fasting combined with calorie restriction is effective for weight loss and cardio-protection in obese women. Nutr J. 2012 Nov 21;11:98. doi: 10.1186/1475-2891-11-98.

    PMID: 23171320BACKGROUND

  • Chaouachi A, Coutts AJ, Chamari K, Wong del P, Chaouachi M, Chtara M, Roky R, Amri M. Effect of Ramadan intermittent fasting on aerobic and anaerobic performance and perception of fatigue in male elite judo athletes. J Strength Cond Res. 2009 Dec;23(9):2702-9. doi: 10.1519/JSC.0b013e3181bc17fc.

    PMID: 19910805BACKGROUND

  • 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. doi: 10.1186/s12967-016-1044-0.

    PMID: 27737674BACKGROUND

  • 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.

    PMID: 27550719BACKGROUND

  • Weigle DS, Duell PB, Connor WE, Steiner RA, Soules MR, Kuijper JL. Effect of fasting, refeeding, and dietary fat restriction on plasma leptin levels. J Clin Endocrinol Metab. 1997 Feb;82(2):561-5. doi: 10.1210/jcem.82.2.3757.

    PMID: 9024254BACKGROUND

  • Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.

    PMID: 33512717DERIVED

MeSH Terms

Conditions

FastingIntermittent Fasting

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Gretchen Casazza, PhD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2018

First Posted

June 26, 2018

Study Start

July 15, 2018

Primary Completion

March 24, 2020

Study Completion

March 24, 2020

Last Updated

April 1, 2020

Record last verified: 2020-03

Locations

US(1)