CClinicalTrials.gg
Sign In
CompletedNCT03404271Updated Sep 12, 2018

Time-Restricted Feeding Plus Resistance Training in Active Females

An interventional study of Beta-hydroxy beta-methylbutyrate and Resistance Training in Healthy Active Females, sponsored by Texas Tech University. Completed at 1 site in United States. Open to female participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-12.

Sponsored by Texas Tech University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Healthy Active Females
03

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Placebo comparator
    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.

    Other: Resistance Training · Dietary Supplement: Protein Supplementation

  • Experimental
    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.

    Other: Resistance Training · Dietary Supplement: Protein Supplementation · Behavioral: Time-Restricted Feeding

  • Experimental
    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.

    Dietary Supplement: Beta-hydroxy beta-methylbutyrate · Other: Resistance Training · Dietary Supplement: Protein Supplementation · Behavioral: Time-Restricted Feeding

Interventions

  • Dietary supplementBeta-hydroxy beta-methylbutyrate

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

    Also known as: HMB

  • OtherResistance Training

    Performing supervised resistance training three times per week.

  • Dietary supplementProtein Supplementation

    Consuming a protein supplement daily.

  • BehavioralTime-Restricted Feeding

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

    Also known as: Intermittent Fasting

05

What researchers measure

Primary outcomes

  1. Fat mass

    Assessed using multi-compartment model

    Time frame: 8 weeks

  2. Fat-free mass

    Assessed using multi-compartment model

    Time frame: 8 weeks

  3. Body fat percentage

    Assessed using multi-compartment model

    Time frame: 8 weeks

  4. Upper body muscle hypertrophy

    Muscle thickness of elbow flexor muscles

    Time frame: 8 weeks

  5. Lower body muscle hypertrophy

    Muscle thickness of knee extensor muscles

    Time frame: 8 weeks

Secondary outcomes

  1. Lower body muscular strength

    Assessed by 1RM on leg press

    Time frame: 8 weeks

  2. Lower body muscular power characteristics

    Assessed during vertical jump and isometric squats

    Time frame: 8 weeks

  3. Lower body muscular endurance

    Assessed by repetitions to failure on leg press

    Time frame: 8 weeks

  4. Upper body muscular strength

    Assessed by 1RM on bench press

    Time frame: 8 weeks

  5. Upper body muscular endurance

    Assessed by repetitions to failure on bench press

    Time frame: 8 weeks

  6. Cortisol awakening response

    Assessed via analysis of saliva samples

    Time frame: 8 weeks

  7. Lipid panel

    Measured from fasted blood sample

    Time frame: 8 weeks

  8. Blood glucose

    Measured from fasted blood sample

    Time frame: 8 weeks

  9. Blood insulin

    Measured from fasted blood sample

    Time frame: 8 weeks

  10. Blood C-reactive protein

    Measured from fasted blood sample

    Time frame: 8 weeks

  11. Blood pressure

    Measured using automated device

    Time frame: 8 weeks

  12. Arterial compliance

    Assessed by applanation tonometry

    Time frame: 8 weeks

  13. Resting metabolic rate

    Assessed by indirect calorimetry

    Time frame: 8 weeks

  14. Respiratory quotient

    Assessed by indirect calorimetry

    Time frame: 8 weeks

  15. Mood

    Assessed by questionnaire

    Time frame: 8 weeks

  16. Eating behavior

    Assessed by three-factor eating questionnaire R18

    Time frame: 8 weeks

  17. Sleep quality

    Assessed by Pittsburgh Sleep Quality Index

    Time frame: 8 weeks

  18. Physical activity level

    Assessed by accelerometry.

    Time frame: 8 weeks

06

Study locations

1 site
  • Texas Tech University
    Lubbock, Texas 79409, United States
07

References and documents

Publications

  • 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. PubMed 27737674 ↗
  • 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. PubMed 27550719 ↗
  • 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. PubMed 26374764 ↗
  • 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. PubMed 33512717 ↗
  • 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. PubMed 31268131 ↗
08

Registry details

Key details

Study ID
NCT03404271
Lead sponsor
Texas Tech University
Collaborators
Metabolic Technologies Inc., Dymatize Enterprises, LLC
Responsible party
Sponsor
First posted
Jan 19, 2018
Start date
Jan 17, 2018
Primary completion
Aug 15, 2018
Completion
Aug 15, 2018
Last update
Sep 12, 2018

Study contacts

Grant Tinsley, Ph.D.
principal investigator · Texas Tech University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Texas Tech University

Start the discussion