Effect of Early Eating and BCAA Supplementation on Body Composition

Effect of Early Time Restricted Eating and BCAA Supplementation vs. Early Time Restricted Eating Alone on Body Composition

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.

Study Overview

• Status: Not yet recruiting
• Conditions: eTRE (Early Time Restricted Eating) With BCAA; eTRE (Early Time Restricted Eating)
• Intervention / Treatment: Behavioral: Time Restricted Eating

Detailed Description

The purpose of the study is to determine the effects of early with BCAA supplementation (5.6g) and early time restricted eating alone on body composition in overweight and obese young adults. It is hypothesized that early time restricted eating with BCAA will provide a more desirable effect (lower fat mass and greater lean mass) on body composition for the participants.

The sample will include 28 overweight/obese young adults, male and female, ranging in age from 18-39 that volunteer to participate in the study. This sample size is justified assuming a standard deviation of 1.5 based on previous studies and using a power of 80% with the statistical significance of 0.05 the resulting n would be 2(1.5)^2*(0.84+1.96)^2/5=7 (Kadam, P., & Bhalerao, S. (2010). Sample size calculation. International journal of Ayurveda research, 1(1), 55). To account for dropouts/non-interest in participation, 14 matched participants will be recruited for each group. All individuals must give written informed consent in order to participate in the study. Exclusion criteria include self-reported: diabetes, smoking, CVD, pregnancy, weight loss medication, physical activity level greater than low/sedentary (7500 steps daily), unstable weight (>4kg loss/gain) for 3 months prior to study commencement.

All participants will be required to have their Body Composition measured using non-invasive densitometry (BodPod). The procedure poses no risk to the participant and takes approximately 5 minutes to complete. This procedure will take place initially one week prior to study commencement and then every 4 weeks after study commencement until the 12 weeks of the study duration are complete. This results in a total of 4 measurements. Upper body strength measurements will be recorded one week prior to commencement of the study and once again after study completion using a 3-rep maximal bench press test. Lower body strength measurements will be recorded one week prior to commencement of the study and once again after study completion using a 3-rep maximal leg press test. Completion of a health-related quality of life questionnaire one week prior to commencement of the study and once again after study completion is also required.

One week prior to study commencement participants will come to the Exercise Nutrition Research Laboratory and initial body composition will be recorded along with baseline upper body strength, lower body strength and health-related quality of life scores. Once the study has commenced, participants will adhere to the daily time windows depending on which group they are randomly assigned. The early time restricted eating with BCAA (5.6g) group will begin their food intake at 0800 h and finish at 1600 h. The early time restricted eating group alone will begin their caloric intake at 0800 h and finish at 1600 h. During the fasting window participants are encouraged to drink plenty of fluids (ad libitum) BUT they must not contain calories, artificial sweeteners or caffeine. Participants will also notify Reed Zehr through email of adherence to their timing windows on a weekly basis. Body composition measurements will take place every 4 weeks upon study commencement. Upon completion of the study, participants will return to the Exercise Nutrition Research Laboratory and final measurements will be recorded of body composition, upper body strength, lower body strength, and health-related quality of life using the same procedure initially.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peter WR Lemon, PhD; Phone Number: 519-661-2111; Email: plemon@uwo.ca
• Study Contact Backup: Name: Reed KK Zehr, MSc; Email: rzehr2@uwo.ca

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 3K7
      • Exercise Nutrition Laboratory (Western University)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• BMI >25
• 18-39 yo
• <7500 steps daily

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: eTRE with BCAA; 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; Eating calories only during a specific feeding window.
Active Comparator: eTRE; participants allocated to this group will only consume calories during 0800h and 1600h daily.	Behavioral: Time Restricted Eating; Eating calories only during a specific feeding window.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
body composition	fat mass vs fat-free mass	<5 mins

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
upper body strength	3 rep max, bench press	< 15 mins
lower body strength	3 rep max, leg press	<15 mins
subjective quality of life questionnaire	4 question survey	< 5 mins

Collaborators and Investigators

• Sponsor: Western University, Canada

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: October 17, 2022
• First Submitted That Met QC Criteria: October 17, 2022
• First Posted (Actual): October 21, 2022

Study Record Updates

• Last Update Posted (Actual): January 23, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 121699

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No