Time-Restricted Feeding Plus Resistance Training in Active Females

NCT ID: NCT03404271

Last Updated: 2018-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-17

Study Completion Date

2018-08-15

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Active Females

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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.

Study Groups

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Normal Diet

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.

Group Type PLACEBO_COMPARATOR

Resistance Training

Intervention Type OTHER

Performing supervised resistance training three times per week.

Protein Supplementation

Intervention Type DIETARY_SUPPLEMENT

Consuming a protein supplement daily.

Time-Restricted Feeding

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.

Group Type EXPERIMENTAL

Resistance Training

Intervention Type OTHER

Performing supervised resistance training three times per week.

Protein Supplementation

Intervention Type DIETARY_SUPPLEMENT

Consuming a protein supplement daily.

Time-Restricted Feeding

Intervention Type BEHAVIORAL

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

Time-Restricted Feeding plus HMB

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.

Group Type EXPERIMENTAL

Beta-hydroxy beta-methylbutyrate

Intervention Type DIETARY_SUPPLEMENT

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

Resistance Training

Intervention Type OTHER

Performing supervised resistance training three times per week.

Protein Supplementation

Intervention Type DIETARY_SUPPLEMENT

Consuming a protein supplement daily.

Time-Restricted Feeding

Intervention Type BEHAVIORAL

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

Interventions

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Beta-hydroxy beta-methylbutyrate

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

Intervention Type DIETARY_SUPPLEMENT

Resistance Training

Performing supervised resistance training three times per week.

Intervention Type OTHER

Protein Supplementation

Consuming a protein supplement daily.

Intervention Type DIETARY_SUPPLEMENT

Time-Restricted Feeding

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

Intervention Type BEHAVIORAL

Other Intervention Names

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HMB Intermittent Fasting

Eligibility Criteria

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Inclusion Criteria

* 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%

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Metabolic Technologies Inc.

INDUSTRY

Sponsor Role collaborator

Dymatize Enterprises, LLC

UNKNOWN

Sponsor Role collaborator

Texas Tech University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Grant Tinsley, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Texas Tech University

Locations

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Texas Tech University

Lubbock, Texas, United States

Site Status

Countries

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United States

References

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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. doi: 10.1186/s12967-016-1044-0.

Reference Type BACKGROUND
PMID: 27737674 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27550719 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26374764 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33512717 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31268131 (View on PubMed)

Other Identifiers

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2017-912

Identifier Type: -

Identifier Source: org_study_id

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