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Time Restricted Feeding, Muscle, and Metabolism (TRIMM)

Primary Purpose

Overweight, Obesity

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Whey protein supplement
Ketogenic aid
Control group - time restricted feeding only
Sponsored by
University of Arkansas, Fayetteville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Overweight

Eligibility Criteria

25 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Resides in Northwest Arkansas
  • Age 25-50 years
  • BMI > 25
  • All ethnicities
  • Female and male

Exclusion Criteria:

  • Food allergies
  • Pregnant or breastfeeding
  • Dietary restrictions (e.g. vegetarian, vegan, etc.)
  • Trying to lose weight in last 3 months
  • Pre-existing health conditions related to obesity (e.g. cardiovascular disease, diabetes, hypertension)
  • Prescription medications related to heart disease or type 2 diabetes
  • Fear of needles
  • Smoker or vaping
  • Currently taking protein supplements or other nutritional supplements which may interfere with study outcomes
  • Consumes >4 alcoholic beverages per week

Sites / Locations

  • University of ArkansasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

TRF-C

TRF-P

TRF-S

Arm Description

Follows time restricted feeding protocol.

Follows time restricted feeding protocol, consumes protein supplement

Follows time restricted feeding protocol, consumes ketogenic supplement

Outcomes

Primary Outcome Measures

Body composition
Body composition measured using dual x-ray absorptiometry to determine the ration of lean/fat-free mass to fat mass.

Secondary Outcome Measures

Whole body protein turnover
Whole body protein turnover will be measured using 15N-alanine
Muscle mass
Muscle mass will be measured using D3-creatine
Body weight
Body weight will be measured in kilograms.
Sleep
Sleep will be assessed using wrist Actigraphy for sleep duration and total time in bed.
Sleep Quality
Sleep quality will be measured using the Pittsburgh Sleep Quality Index survey
Mood
Mood will be assessed using the Profile of Mood States Questionnaire
Grit
Grit will be assessed using the grit questionnaire.
Self-reported physical activity
Physical activity will be measured using the iPAQ survey
Dietary intake
Dietary intake will be measured using weighed, 3-day food records
Fasting glucose
Glucose will be measured as mg/dl
Hand grip
Hand grip will be measured using a dynamometer.
Amino acids and metabolites
Blood will be collected and plasma amino acids and metabolites will be assessed using commercially available kit for amino acid analysis for all circulating amino acids.

Full Information

First Posted
June 16, 2021
Last Updated
June 25, 2021
Sponsor
University of Arkansas, Fayetteville
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1. Study Identification

Unique Protocol Identification Number
NCT04949451
Brief Title
Time Restricted Feeding, Muscle, and Metabolism
Acronym
TRIMM
Official Title
Time Restricted Feeding Intervention for Muscle and Metabolic Health (TRIMM)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 13, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
May 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arkansas, Fayetteville

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Effective nutrition strategies for combatting and/or preventing obesity still need to be identified. This has been the case despite the numerous and different approaches that have been taken. Potential targets for combatting/preventing obesity have been identified, but long-term solutions have not emerged. This study uses time restricted feeding to study the role of dietary protein in obesity prevention and/or treatment. The objectives are to determine the role of skeletal muscle mass as a driver of energy-sensing mechanisms and peripheral signals that regulate appetite and energy intake in overweight and obese adults and to determine the effects of protein timing on muscle mass to regulate appetite and energy intake in overweight and obese adults.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TRF-C
Arm Type
Placebo Comparator
Arm Description
Follows time restricted feeding protocol.
Arm Title
TRF-P
Arm Type
Experimental
Arm Description
Follows time restricted feeding protocol, consumes protein supplement
Arm Title
TRF-S
Arm Type
Experimental
Arm Description
Follows time restricted feeding protocol, consumes ketogenic supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey protein supplement
Intervention Description
Participants consume whey protein at the beginning of the eating period.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ketogenic aid
Intervention Description
Participants consume ketogenic aid upon waking.
Intervention Type
Other
Intervention Name(s)
Control group - time restricted feeding only
Intervention Description
Time restricted feeding.
Primary Outcome Measure Information:
Title
Body composition
Description
Body composition measured using dual x-ray absorptiometry to determine the ration of lean/fat-free mass to fat mass.
Time Frame
Change is being assessed at baseline and final day (day 120) of the intervention.
Secondary Outcome Measure Information:
Title
Whole body protein turnover
Description
Whole body protein turnover will be measured using 15N-alanine
Time Frame
Change is being assessed at baseline and final day (day 120) of the intervention.
Title
Muscle mass
Description
Muscle mass will be measured using D3-creatine
Time Frame
Change is being assessed at baseline and final day (day 120) of the intervention.
Title
Body weight
Description
Body weight will be measured in kilograms.
Time Frame
Change is being assessed at baseline, 4, 8, and 12 weeks.
Title
Sleep
Description
Sleep will be assessed using wrist Actigraphy for sleep duration and total time in bed.
Time Frame
Change is being assessed at baseline and 12 weeks
Title
Sleep Quality
Description
Sleep quality will be measured using the Pittsburgh Sleep Quality Index survey
Time Frame
Change is being assessed at baseline, 4, 8, and 12 weeks
Title
Mood
Description
Mood will be assessed using the Profile of Mood States Questionnaire
Time Frame
Change is being assessed at baseline, 4, 8, and 12 weeks
Title
Grit
Description
Grit will be assessed using the grit questionnaire.
Time Frame
Change is being assessed at baseline, 4, 8, and 12 weeks
Title
Self-reported physical activity
Description
Physical activity will be measured using the iPAQ survey
Time Frame
Change is being assessed at baseline, 4, 8, and 12 weeks
Title
Dietary intake
Description
Dietary intake will be measured using weighed, 3-day food records
Time Frame
Change is being assessed at baseline, 4, 8, and 12 weeks
Title
Fasting glucose
Description
Glucose will be measured as mg/dl
Time Frame
Change is being assessed at baseline, 4, 8, and 12 weeks
Title
Hand grip
Description
Hand grip will be measured using a dynamometer.
Time Frame
Change is being assessed at baseline, 4, 8, and 12 weeks
Title
Amino acids and metabolites
Description
Blood will be collected and plasma amino acids and metabolites will be assessed using commercially available kit for amino acid analysis for all circulating amino acids.
Time Frame
Change is being assessed at baseline, 4, 8, and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Resides in Northwest Arkansas Age 25-50 years BMI > 25 All ethnicities Female and male Exclusion Criteria: Food allergies Pregnant or breastfeeding Dietary restrictions (e.g. vegetarian, vegan, etc.) Trying to lose weight in last 3 months Pre-existing health conditions related to obesity (e.g. cardiovascular disease, diabetes, hypertension) Prescription medications related to heart disease or type 2 diabetes Fear of needles Smoker or vaping Currently taking protein supplements or other nutritional supplements which may interfere with study outcomes Consumes >4 alcoholic beverages per week
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jamie Baum, PhD
Phone
479-575-4474
Email
baum@uark.edu
Facility Information:
Facility Name
University of Arkansas
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72704
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamie I Baum, PhD
Phone
479-575-4474
Email
baum@uark.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Time Restricted Feeding, Muscle, and Metabolism

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