eTRE (Early Time Restricted Eating) With BCAANCT05589142
Effect of Early Eating and BCAA Supplementation on Body Composition
A study testing Time Restricted Eating in people with eTRE (Early Time Restricted Eating) With BCAA and eTRE (Early Time Restricted Eating), run by Western University, Canada at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- eTRE (Early Time Restricted Eating) With BCAA, eTRE (Early Time Restricted Eating)
- What is being tested?
- Time Restricted Eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI >25
- 18-39 yo
- <7500 steps daily
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Reed KK Zehr, MSc contact
Canada1 site
Exercise Nutrition Laboratory (Western University)
London, Ontario, N6A 3K7
About this study
Official title: 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.
Read the 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.
- Being tested
- Time Restricted Eating
- Medical subject headings
- Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time Restricted EatingBehavioural
Eating calories only during a specific feeding window.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Time Restricted Eating |
| eTRE | Active comparator | participants allocated to this group will only consume calories during 0800h and 1600h daily. Receives: Behavioral: Time Restricted Eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
body composition
fat mass vs fat-free mass
Measured: <5 mins
Secondary outcomes (3)
upper body strength
3 rep max, bench press
Measured: < 15 mins
lower body strength
3 rep max, leg press
Measured: <15 mins
subjective quality of life questionnaire
4 question survey
Measured: < 5 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start1 Mar 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for eTRE (Early Time Restricted Eating) With BCAAStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Lemon, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05589142
- Sponsor's protocol ID
- 121699
- Status last verified
- Jan 2023
- First submitted
- 17 Oct 2022
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Time Restricted Eating and BCAA Supplementation vs. Early Time Restricted Eating Alone on Body Composition
- ClinicalTrials.gov ID
- NCT05589142
- Acronym / sponsor ID
- 121699
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 21 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eTRE with BCAA | Experimental | Behavioral: Time Restricted Eatingparticipants 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. |
| eTRE | Active comparator | Behavioral: Time Restricted Eatingparticipants allocated to this group will only consume calories during 0800h and 1600h daily. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI >25
- 18-39 yo
- <7500 steps daily
Key exclusion criteria (6 listed)
- diabetes, smoking, CVD (self-reported)
- BMI < 24.9
- pregnant, medication for weight loss (self-reported)
- -> 7500 steps/day
- employed in shift work position
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time Restricted EatingEating calories only during a specific feeding window. | Behavioural | eTRE, eTRE with BCAA |
Primary outcome
body composition
Time frame: <5 mins
fat mass vs fat-free mass
3 secondary outcomes
upper body strength
Time frame: < 15 mins
lower body strength
Time frame: <15 mins
subjective quality of life questionnaire
Time frame: < 5 mins
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reed KK Zehr, MSc contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time Restricted Eating in people with eTRE (Early Time Restricted Eating) With BCAA and eTRE (Early Time Restricted Eating), run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter WR Lemon, PhD (519-661-2111, plemon@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
body composition (time frame: <5 mins). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2023.