NCT03404271

Brief Summary

The objective of this study is to examine the effects of time-restricted feeding (TRF; consuming all calories within an 8-hour period of time each day) and resistance training, with or without the addition of the dietary supplement HMB, on body composition, muscular performance and physiological outcomes in active females.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

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

January 4, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

January 17, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 19, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2018

Completed
Last Updated

September 12, 2018

Status Verified

September 1, 2018

Enrollment Period

7 months

First QC Date

January 4, 2018

Last Update Submit

September 11, 2018

Conditions

Healthy Active Females

Outcome Measures

Primary Outcomes (5)

  • Fat mass

    Assessed using multi-compartment model

    8 weeks

  • Fat-free mass

    Assessed using multi-compartment model

    8 weeks

  • Body fat percentage

    Assessed using multi-compartment model

    8 weeks

  • Upper body muscle hypertrophy

    Muscle thickness of elbow flexor muscles

    8 weeks

  • Lower body muscle hypertrophy

    Muscle thickness of knee extensor muscles

    8 weeks

Secondary Outcomes (18)

  • Lower body muscular strength

    8 weeks

  • Lower body muscular power characteristics

    8 weeks

  • Lower body muscular endurance

    8 weeks

  • Upper body muscular strength

    8 weeks

  • Upper body muscular endurance

    8 weeks

  • +13 more secondary outcomes

Study Arms (3)

Normal Diet

PLACEBO COMPARATOR

Participants in the normal diet (ND) group will follow a traditional dietary pattern, consisting of eating breakfast and continuing to eat throughout the day until the evening. Participants in this group will receive placebo capsules. Participants in all groups will follow an identical resistance training program and be provided with whey protein supplements.

Other: Resistance TrainingDietary Supplement: Protein Supplementation

Time-Restricted Feeding

EXPERIMENTAL

Participants in the time-restricted feeding (TRF) group will consume all calories within an 8-hour period of time each day. Participants in this group will receive placebo capsules. Participants in all groups will follow an identical resistance training program and be provided with whey protein supplements.

Other: Resistance TrainingDietary Supplement: Protein SupplementationBehavioral: Time-Restricted Feeding

Time-Restricted Feeding plus HMB

EXPERIMENTAL

Participants in the time-restricted feeding plus HMB (TRF+HMB) group will consume all calories within an 8-hour period of time each day. Participants in this group will receive HMB capsules. Participants in all groups will follow an identical resistance training program and be provided with whey protein supplements.

Dietary Supplement: Beta-hydroxy beta-methylbutyrateOther: Resistance TrainingDietary Supplement: Protein SupplementationBehavioral: Time-Restricted Feeding

Interventions

Beta-hydroxy beta-methylbutyrateDIETARY_SUPPLEMENT

3 grams per day of the calcium salt form of beta-hydroxy beta-methylbutyrate (HMB).

Also known as: HMB
Time-Restricted Feeding plus HMB
Resistance TrainingOTHER

Performing supervised resistance training three times per week.

Normal DietTime-Restricted FeedingTime-Restricted Feeding plus HMB
Protein SupplementationDIETARY_SUPPLEMENT

Consuming a protein supplement daily.

Normal DietTime-Restricted FeedingTime-Restricted Feeding plus HMB
Time-Restricted FeedingBEHAVIORAL

Consuming all calories within a specified 8-hour period of time each day.

Also known as: Intermittent Fasting
Time-Restricted FeedingTime-Restricted Feeding plus HMB

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female between 18 and 30 years of age
  • Current university affiliation
  • Weighing at least 110 pounds
  • Generally healthy
  • Resistance-trained
  • Schedule availability to complete supervised resistance training
  • Body fat percentage between 15 and 29%

You may not qualify if:

  • Pregnant or trying to become pregnant
  • Currently breastfeeding
  • Any disease, condition or orthopedic limitation that would prevent safe participation in resistance training or time-restricted feeding
  • Current smoker
  • Presence of pacemaker or other electrical implant
  • Allergic to dairy proteins

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Tech University

Lubbock, Texas, 79409, United States

Location

Related Publications (5)

  • 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

  • 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

  • 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

  • Tinsley GM, Moore ML, Graybeal AJ, Paoli A, Kim Y, Gonzales JU, Harry JR, VanDusseldorp TA, Kennedy DN, Cruz MR. Time-restricted feeding plus resistance training in active females: a randomized trial. Am J Clin Nutr. 2019 Sep 1;110(3):628-640. doi: 10.1093/ajcn/nqz126.

    PMID: 31268131DERIVED

MeSH Terms

Interventions

beta-hydroxyisovaleric acidResistance Training

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Grant Tinsley, Ph.D.

    Texas Tech University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Investigators and participants will be blinded to dietary supplement (i.e. HMB or placebo). However, neither the investigators nor participants will be blinded to dietary intervention (TRF or ND) due to the nature of these dietary programs. When possible, outcome assessors will be blinded to group assignment.
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2018

First Posted

January 19, 2018

Study Start

January 17, 2018

Primary Completion

August 15, 2018

Study Completion

August 15, 2018

Last Updated

September 12, 2018

Record last verified: 2018-09

Locations

US(1)