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

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

    • Texas
      • Lubbock, Texas, United States, 79409
        • Texas Tech University

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.
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:
  • Intermittent Fasting
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:
  • Intermittent Fasting
3 grams per day of the calcium salt form of beta-hydroxy beta-methylbutyrate (HMB).
Other Names:
  • HMB

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
Measured from fasted blood sample
8 weeks
Blood glucose
Time Frame: 8 weeks
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
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.

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.

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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