- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03404271
Time-Restricted Feeding Plus Resistance Training in Active Females
September 11, 2018 updated by: Texas Tech University
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Lubbock, Texas, United States, 79409
- Texas Tech University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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Performing supervised resistance training three times per week.
Consuming a protein supplement daily.
|
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.
|
Performing supervised resistance training three times per week.
Consuming a protein supplement daily.
Consuming all calories within a specified 8-hour period of time each day.
Other Names:
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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.
|
Performing supervised resistance training three times per week.
Consuming a protein supplement daily.
Consuming all calories within a specified 8-hour period of time each day.
Other Names:
3 grams per day of the calcium salt form of beta-hydroxy beta-methylbutyrate (HMB).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fat mass
Time Frame: 8 weeks
|
Assessed using multi-compartment model
|
8 weeks
|
Fat-free mass
Time Frame: 8 weeks
|
Assessed using multi-compartment model
|
8 weeks
|
Body fat percentage
Time Frame: 8 weeks
|
Assessed using multi-compartment model
|
8 weeks
|
Upper body muscle hypertrophy
Time Frame: 8 weeks
|
Muscle thickness of elbow flexor muscles
|
8 weeks
|
Lower body muscle hypertrophy
Time Frame: 8 weeks
|
Muscle thickness of knee extensor muscles
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lower body muscular strength
Time Frame: 8 weeks
|
Assessed by 1RM on leg press
|
8 weeks
|
Lower body muscular power characteristics
Time Frame: 8 weeks
|
Assessed during vertical jump and isometric squats
|
8 weeks
|
Lower body muscular endurance
Time Frame: 8 weeks
|
Assessed by repetitions to failure on leg press
|
8 weeks
|
Upper body muscular strength
Time Frame: 8 weeks
|
Assessed by 1RM on bench press
|
8 weeks
|
Upper body muscular endurance
Time Frame: 8 weeks
|
Assessed by repetitions to failure on bench press
|
8 weeks
|
Cortisol awakening response
Time Frame: 8 weeks
|
Assessed via analysis of saliva samples
|
8 weeks
|
Lipid panel
Time Frame: 8 weeks
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Measured from fasted blood sample
|
8 weeks
|
Blood glucose
Time Frame: 8 weeks
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Measured from fasted blood sample
|
8 weeks
|
Blood insulin
Time Frame: 8 weeks
|
Measured from fasted blood sample
|
8 weeks
|
Blood C-reactive protein
Time Frame: 8 weeks
|
Measured from fasted blood sample
|
8 weeks
|
Blood pressure
Time Frame: 8 weeks
|
Measured using automated device
|
8 weeks
|
Arterial compliance
Time Frame: 8 weeks
|
Assessed by applanation tonometry
|
8 weeks
|
Resting metabolic rate
Time Frame: 8 weeks
|
Assessed by indirect calorimetry
|
8 weeks
|
Respiratory quotient
Time Frame: 8 weeks
|
Assessed by indirect calorimetry
|
8 weeks
|
Mood
Time Frame: 8 weeks
|
Assessed by questionnaire
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8 weeks
|
Eating behavior
Time Frame: 8 weeks
|
Assessed by three-factor eating questionnaire R18
|
8 weeks
|
Sleep quality
Time Frame: 8 weeks
|
Assessed by Pittsburgh Sleep Quality Index
|
8 weeks
|
Physical activity level
Time Frame: 8 weeks
|
Assessed by accelerometry.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Grant Tinsley, Ph.D., Texas Tech University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- 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.
- 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:CD013496. doi: 10.1002/14651858.CD013496.pub2.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 17, 2018
Primary Completion (Actual)
August 15, 2018
Study Completion (Actual)
August 15, 2018
Study Registration Dates
First Submitted
January 4, 2018
First Submitted That Met QC Criteria
January 11, 2018
First Posted (Actual)
January 19, 2018
Study Record Updates
Last Update Posted (Actual)
September 12, 2018
Last Update Submitted That Met QC Criteria
September 11, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 2017-912
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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