Clinical trial NCT03404271: Time-Restricted Feeding Plus Resistance Training in Active Females
Official title: Time-Restricted Feeding Plus Resistance Training in Active Females: Effects on Body Composition, Muscular Performance and Physiological Variables
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Active Females
Lead sponsor: Texas Tech University
Sponsor class: OTHER
Collaborators: name: Metabolic Technologies Inc.
name: Dymatize Enterprises, LLC
First posted: 2018-01-19
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Fat mass
timeFrame: 8 weeks
measure: Fat-free mass
timeFrame: 8 weeks
measure: Body fat percentage
timeFrame: 8 weeks
measure: Upper body muscle hypertrophy
timeFrame: 8 weeks
measure: Lower body muscle hypertrophy
timeFrame: 8 weeks
Secondary outcomes:
measure: Lower body muscular strength
timeFrame: 8 weeks
measure: Lower body muscular power characteristics
timeFrame: 8 weeks
measure: Lower body muscular endurance
timeFrame: 8 weeks
measure: Upper body muscular strength
timeFrame: 8 weeks
measure: Upper body muscular endurance
timeFrame: 8 weeks
measure: Cortisol awakening response
timeFrame: 8 weeks
measure: Lipid panel
timeFrame: 8 weeks
measure: Blood glucose
timeFrame: 8 weeks
measure: Blood insulin
timeFrame: 8 weeks
measure: Blood C-reactive protein
timeFrame: 8 weeks
measure: Blood pressure
timeFrame: 8 weeks
measure: Arterial compliance
timeFrame: 8 weeks
measure: Resting metabolic rate
timeFrame: 8 weeks
measure: Respiratory quotient
timeFrame: 8 weeks
measure: Mood
timeFrame: 8 weeks
measure: Eating behavior
timeFrame: 8 weeks
measure: Sleep quality
timeFrame: 8 weeks
measure: Physical activity level
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Texas Tech University
state: Texas
Study officials:
affiliation: Texas Tech University
name: Grant Tinsley, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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.
citation: 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.
citation: 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.