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Time-Restricted Feeding Plus Resistance Training in Active Females

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03404271
Recruitment Status : Completed
First Posted : January 19, 2018
Last Update Posted : September 12, 2018
Sponsor:
Collaborators:
Metabolic Technologies Inc.
Dymatize Enterprises, LLC
Information provided by (Responsible Party):
Texas Tech University

Tracking Information
First Submitted Date  ICMJE January 4, 2018
First Posted Date  ICMJE January 19, 2018
Last Update Posted Date September 12, 2018
Actual Study Start Date  ICMJE January 17, 2018
Actual Primary Completion Date August 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2018)
  • Fat mass [ Time Frame: 8 weeks ]
    Assessed using multi-compartment model
  • Fat-free mass [ Time Frame: 8 weeks ]
    Assessed using multi-compartment model
  • Body fat percentage [ Time Frame: 8 weeks ]
    Assessed using multi-compartment model
  • Upper body muscle hypertrophy [ Time Frame: 8 weeks ]
    Muscle thickness of elbow flexor muscles
  • Lower body muscle hypertrophy [ Time Frame: 8 weeks ]
    Muscle thickness of knee extensor muscles
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2018)
  • Lower body muscular strength [ Time Frame: 8 weeks ]
    Assessed by 1RM on leg press
  • Lower body muscular power characteristics [ Time Frame: 8 weeks ]
    Assessed during vertical jump and isometric squats
  • Lower body muscular endurance [ Time Frame: 8 weeks ]
    Assessed by repetitions to failure on leg press
  • Upper body muscular strength [ Time Frame: 8 weeks ]
    Assessed by 1RM on bench press
  • Upper body muscular endurance [ Time Frame: 8 weeks ]
    Assessed by repetitions to failure on bench press
  • Cortisol awakening response [ Time Frame: 8 weeks ]
    Assessed via analysis of saliva samples
  • Lipid panel [ Time Frame: 8 weeks ]
    Measured from fasted blood sample
  • Blood glucose [ Time Frame: 8 weeks ]
    Measured from fasted blood sample
  • Blood insulin [ Time Frame: 8 weeks ]
    Measured from fasted blood sample
  • Blood C-reactive protein [ Time Frame: 8 weeks ]
    Measured from fasted blood sample
  • Blood pressure [ Time Frame: 8 weeks ]
    Measured using automated device
  • Arterial compliance [ Time Frame: 8 weeks ]
    Assessed by applanation tonometry
  • Resting metabolic rate [ Time Frame: 8 weeks ]
    Assessed by indirect calorimetry
  • Respiratory quotient [ Time Frame: 8 weeks ]
    Assessed by indirect calorimetry
  • Mood [ Time Frame: 8 weeks ]
    Assessed by questionnaire
  • Eating behavior [ Time Frame: 8 weeks ]
    Assessed by three-factor eating questionnaire R18
  • Sleep quality [ Time Frame: 8 weeks ]
    Assessed by Pittsburgh Sleep Quality Index
  • Physical activity level [ Time Frame: 8 weeks ]
    Assessed by accelerometry.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Time-Restricted Feeding Plus Resistance Training in Active Females
Official Title  ICMJE Time-Restricted Feeding Plus Resistance Training in Active Females: Effects on Body Composition, Muscular Performance and Physiological Variables
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Investigators and participants will be blinded to dietary supplement (i.e. HMB or placebo). However, neither the investigators nor participants will be blinded to dietary intervention (TRF or ND) due to the nature of these dietary programs. When possible, outcome assessors will be blinded to group assignment.
Primary Purpose: Other
Condition  ICMJE Healthy Active Females
Intervention  ICMJE
  • Dietary Supplement: Beta-hydroxy beta-methylbutyrate
    3 grams per day of the calcium salt form of beta-hydroxy beta-methylbutyrate (HMB).
    Other Name: HMB
  • 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 Name: Intermittent Fasting
Study Arms  ICMJE
  • 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.
    Interventions:
    • 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.
    Interventions:
    • 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.
    Interventions:
    • Dietary Supplement: Beta-hydroxy beta-methylbutyrate
    • Other: Resistance Training
    • Dietary Supplement: Protein Supplementation
    • Behavioral: Time-Restricted Feeding
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 11, 2018)
40
Original Estimated Enrollment  ICMJE
 (submitted: January 11, 2018)
36
Actual Study Completion Date  ICMJE August 15, 2018
Actual Primary Completion Date August 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03404271
Other Study ID Numbers  ICMJE 2017-912
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Texas Tech University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Texas Tech University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Metabolic Technologies Inc.
  • Dymatize Enterprises, LLC
Investigators  ICMJE
Principal Investigator: Grant Tinsley, Ph.D. Texas Tech University
PRS Account Texas Tech University
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP