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Healthy Active FemalesNCT03404271

Time-Restricted Feeding Plus Resistance Training in Active Females

A study testing Beta-hydroxy beta-methylbutyrate, Resistance Training and Protein Supplementation in people with Healthy Active Females, run by Texas Tech University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 30 years, women onlyHealthy volunteers can take part
Conditions the study is for
Healthy Active Females
What is being tested?
Beta-hydroxy beta-methylbutyrate, Resistance Training and Protein Supplementation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited States
Study dates
17 Jan 2018to 15 Aug 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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%

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Texas Tech University

    Lubbock, Texas, 79409

Other trials in United States

About this study

Official title: Time-Restricted Feeding Plus Resistance Training in Active Females: Effects on Body Composition, Muscular Performance and Physiological Variables

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.

Being tested
Beta-hydroxy beta-methylbutyrate, Resistance Training, Protein Supplementation, Time-Restricted Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Beta-hydroxy beta-methylbutyrateDietary supplement

    Also called HMB

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

  • Resistance TrainingOther

    Performing supervised resistance training three times per week.

  • Protein SupplementationDietary supplement

    Consuming a protein supplement daily.

  • Time-Restricted FeedingBehavioural

    Also called Intermittent Fasting

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

Study groups in NCT03404271
Study groupRoleWhat they receive
Normal DietPlacebo comparatorParticipants 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.
Receives: Other: Resistance Training; Dietary Supplement: Protein Supplementation
Time-Restricted FeedingExperimentalParticipants 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.
Receives: Other: Resistance Training; Dietary Supplement: Protein Supplementation; Behavioral: Time-Restricted Feeding
Time-Restricted Feeding plus HMBExperimentalParticipants 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.
Receives: Dietary Supplement: Beta-hydroxy beta-methylbutyrate; Other: Resistance Training; Dietary Supplement: Protein Supplementation; Behavioral: Time-Restricted Feeding

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fat mass

    Assessed using multi-compartment model

    Measured: 8 weeks

  2. Fat-free mass

    Assessed using multi-compartment model

    Measured: 8 weeks

  3. Body fat percentage

    Assessed using multi-compartment model

    Measured: 8 weeks

  4. Upper body muscle hypertrophy

    Muscle thickness of elbow flexor muscles

    Measured: 8 weeks

  5. Lower body muscle hypertrophy

    Muscle thickness of knee extensor muscles

    Measured: 8 weeks

Secondary outcomes (18)

  1. Lower body muscular strength

    Assessed by 1RM on leg press

    Measured: 8 weeks

  2. Lower body muscular power characteristics

    Assessed during vertical jump and isometric squats

    Measured: 8 weeks

  3. Lower body muscular endurance

    Assessed by repetitions to failure on leg press

    Measured: 8 weeks

  4. Upper body muscular strength

    Assessed by 1RM on bench press

    Measured: 8 weeks

  5. Upper body muscular endurance

    Assessed by repetitions to failure on bench press

    Measured: 8 weeks

  6. Cortisol awakening response

    Assessed via analysis of saliva samples

    Measured: 8 weeks

  7. Lipid panel

    Measured from fasted blood sample

    Measured: 8 weeks

  8. Blood glucose

    Measured from fasted blood sample

    Measured: 8 weeks

  9. Blood insulin

    Measured from fasted blood sample

    Measured: 8 weeks

  10. Blood C-reactive protein

    Measured from fasted blood sample

    Measured: 8 weeks

  11. Blood pressure

    Measured using automated device

    Measured: 8 weeks

  12. Arterial compliance

    Assessed by applanation tonometry

    Measured: 8 weeks

  13. Resting metabolic rate

    Assessed by indirect calorimetry

    Measured: 8 weeks

  14. Respiratory quotient

    Assessed by indirect calorimetry

    Measured: 8 weeks

  15. Mood

    Assessed by questionnaire

    Measured: 8 weeks

  16. Eating behavior

    Assessed by three-factor eating questionnaire R18

    Measured: 8 weeks

  17. Sleep quality

    Assessed by Pittsburgh Sleep Quality Index

    Measured: 8 weeks

  18. Physical activity level

    Assessed by accelerometry.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2018
  2. Study start17 Jan 2018
  3. Primary completion15 Aug 2018
  4. Study completion15 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Factorial
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03404271
Sponsor's protocol ID
2017-912
Status last verified
Sep 2018
First submitted
4 Jan 2018
Last updated
12 Sep 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Beta-hydroxy beta-methylbutyrate, Resistance Training and Protein Supplementation in people with Healthy Active Females, run by Texas Tech University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fat mass (time frame: 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03404271, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2018.

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