Effect of Early Eating and BCAA Supplementation on Body Composition

NCT05589142 | Unknown

• 1 other identifier: 121699
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To our knowledge, as of this day there are only four studies which examined the effects of eTRE with a duration of 12 weeks. There are no studies that examined this phenomenon beyond 12 weeks, one study that lasted five weeks and four studies that lasted 4 weeks or less, some even days. The four studies that lasted 12 weeks in duration all have opportunities to improve upon, which will be discussed here. The first study performed by Gabel et al., focused primarily on measuring body weight, not body composition in older adults. The eating window also began later in the morning at 1000h and finished at 1800h. There also was no restriction on participants consuming caffeine during the fasting window. The second study conducted by Gasmi et al., was focused on strictly older male participants that were active and healthy, again, without measuring body composition. The third study conducted by Wilkinson et al., did not measure body composition and the eating window lasted 10 hours instead of 8. The fourth study performed by Chow et al., examined eTRE with adults aged 45+/-12 years old and did not mention any exclusion criteria based upon physical activity levels or restrictions on caffeine/artificial sweetener intake during the fasting window. Furthermore, none of the studies mentioned above examined eTRE against eTRE with BCAA supplementation directly. We believe that the proposed study will address the concerns mentioned previously and further knowledge associated with eTRE.

Conditions

eTRE (Early Time Restricted Eating) With BCAA; eTRE (Early Time Restricted Eating)

Outcome Measures

Primary Outcomes (1)

• body composition

  fat mass vs fat-free mass

  <5 mins

Secondary Outcomes (3)

• upper body strength

  < 15 mins

• lower body strength

  <15 mins

• subjective quality of life questionnaire

  < 5 mins

Study Arms (2)

eTRE with BCAA

EXPERIMENTAL

participants allocated to this group will only consume calories during 0800h and 1600h daily. Prior to sleep, participants will consume a single bolus of 5.6g of BCAA.

Behavioral: Time Restricted Eating

eTRE

ACTIVE COMPARATOR

participants allocated to this group will only consume calories during 0800h and 1600h daily.

Behavioral: Time Restricted Eating

Interventions

Time Restricted Eating BEHAVIORAL

Eating calories only during a specific feeding window.

eTRE; eTRE with BCAA

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• BMI \>25
• \<7500 steps daily

You may not qualify if:

• diabetes, smoking, CVD (self-reported)
• BMI \< 24.9
• pregnant, medication for weight loss (self-reported)
• \> 7500 steps/day
• employed in shift work position
• unstable weight for 3 months prior to study (\>4kg weight loss/gain)

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

Exercise Nutrition Laboratory (Western University)

London, Ontario, N6A 3K7, Canada

Location

MeSH Terms

Conditions

Intermittent Fasting

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior

Central Study Contacts

Peter WR Lemon, PhD

CONTACT

519-661-2111; plemon@uwo.ca

Reed KK Zehr, MSc

CONTACT

rzehr2@uwo.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Peter Lemon

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 21, 2022
• Study Start: March 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 23, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)