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Time-Restricted Feeding Plus Resistance Training in Active Females

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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

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.

Condition or disease Intervention/treatment Phase
Healthy Active Females Dietary Supplement: Beta-hydroxy beta-methylbutyrate Other: Resistance Training Dietary Supplement: Protein Supplementation Behavioral: Time-Restricted Feeding Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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
Official Title: Time-Restricted Feeding Plus Resistance Training in Active Females: Effects on Body Composition, Muscular Performance and Physiological Variables
Actual Study Start Date : January 17, 2018
Actual Primary Completion Date : August 15, 2018
Actual Study Completion Date : August 15, 2018

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.
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 Name: 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.
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




Primary Outcome Measures :
  1. Fat mass [ Time Frame: 8 weeks ]
    Assessed using multi-compartment model

  2. Fat-free mass [ Time Frame: 8 weeks ]
    Assessed using multi-compartment model

  3. Body fat percentage [ Time Frame: 8 weeks ]
    Assessed using multi-compartment model

  4. Upper body muscle hypertrophy [ Time Frame: 8 weeks ]
    Muscle thickness of elbow flexor muscles

  5. Lower body muscle hypertrophy [ Time Frame: 8 weeks ]
    Muscle thickness of knee extensor muscles


Secondary Outcome Measures :
  1. Lower body muscular strength [ Time Frame: 8 weeks ]
    Assessed by 1RM on leg press

  2. Lower body muscular power characteristics [ Time Frame: 8 weeks ]
    Assessed during vertical jump and isometric squats

  3. Lower body muscular endurance [ Time Frame: 8 weeks ]
    Assessed by repetitions to failure on leg press

  4. Upper body muscular strength [ Time Frame: 8 weeks ]
    Assessed by 1RM on bench press

  5. Upper body muscular endurance [ Time Frame: 8 weeks ]
    Assessed by repetitions to failure on bench press

  6. Cortisol awakening response [ Time Frame: 8 weeks ]
    Assessed via analysis of saliva samples

  7. Lipid panel [ Time Frame: 8 weeks ]
    Measured from fasted blood sample

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

  9. Blood insulin [ Time Frame: 8 weeks ]
    Measured from fasted blood sample

  10. Blood C-reactive protein [ Time Frame: 8 weeks ]
    Measured from fasted blood sample

  11. Blood pressure [ Time Frame: 8 weeks ]
    Measured using automated device

  12. Arterial compliance [ Time Frame: 8 weeks ]
    Assessed by applanation tonometry

  13. Resting metabolic rate [ Time Frame: 8 weeks ]
    Assessed by indirect calorimetry

  14. Respiratory quotient [ Time Frame: 8 weeks ]
    Assessed by indirect calorimetry

  15. Mood [ Time Frame: 8 weeks ]
    Assessed by questionnaire

  16. Eating behavior [ Time Frame: 8 weeks ]
    Assessed by three-factor eating questionnaire R18

  17. Sleep quality [ Time Frame: 8 weeks ]
    Assessed by Pittsburgh Sleep Quality Index

  18. Physical activity level [ Time Frame: 8 weeks ]
    Assessed by accelerometry.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03404271


Locations
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United States, Texas
Texas Tech University
Lubbock, Texas, United States, 79409
Sponsors and Collaborators
Texas Tech University
Metabolic Technologies Inc.
Dymatize Enterprises, LLC
Investigators
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Principal Investigator: Grant Tinsley, Ph.D. Texas Tech University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Texas Tech University
ClinicalTrials.gov Identifier: NCT03404271     History of Changes
Other Study ID Numbers: 2017-912
First Posted: January 19, 2018    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No