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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Performing supervised resistance training three times per week.
Dietary supplement: Protein Supplementation
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.
Other: Resistance Training
Performing supervised resistance training three times per week.
Dietary supplement: Protein Supplementation
Consuming a protein supplement daily.
Behavioral: Time-Restricted Feeding
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.
Other: Resistance Training
Performing supervised resistance training three times per week.
Dietary supplement: Protein Supplementation
Consuming a protein supplement daily.
Behavioral: Time-Restricted Feeding
Consuming all calories within a specified 8-hour period of time each day.
Other Names:
  • Intermittent Fasting
Dietary supplement: Beta-hydroxy beta-methylbutyrate
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Texas Tech University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Metabolic Technologies Inc.
Dymatize Enterprises, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 17, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 19, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 12, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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