Weight LossNCT02629900
The Effect of Time Restricted Feeding on Fat Mass in Overweight Women
A study testing Time restricted feeding in people with Weight Loss, run by University of Western Ontario, Canada at 1 site in Canada.
Trial summary
Participants will complete a one-month intervention where they are will restrict their daily food intake to an 8-hour time period, i.e., between 1200 to 2000 hours. During the remaining 16-hour intermittent fasting period (2000 to 1200 hours) participants will be allowed to drink zero calorie beverages (diet soda pop… Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Weight Loss
- What is being tested?
- Time restricted feeding
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2016to Apr 2016
- 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 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Asymptomatic participants between the ages of 18-30 years with body mass index ˃25 will be studied
Who cannot join
- Diabetic
- Pregnant
- Individuals with a history of fainting
- Low blood sugar
- Heart disease, migranes, or heart burn
- Participants less then 18 of age
- Anyone who for health or performance reasons should not skip breakfast will be excluded. These will be assessed by self report
Trial locations and contacts
1 site in 1 country.
Siobhan Smith, Bsc contact
Canada1 site, 1 recruiting
- Recruiting
Exercise Nutrition Research Laboratory, Western University
London, Ontario, N6A 3K7
Peter Lemon, PhD, 519 661 2111 ext. 88139, plemon@uwo.ca
Peter Lemon, PhD
About this study
Participants will complete a one-month intervention where they are will restrict their daily food intake to an 8-hour time period, i.e., between 1200 to 2000 hours. During the remaining 16-hour intermittent fasting period (2000 to 1200 hours) participants will be allowed to drink zero calorie beverages (diet soda pop, black coffee, tea, water, etc) in order to maintain normal hydration. There will be no attempt to restrict food intake. Rather simply to restrict the time period each day when food is consumed. Participants' body mass, fat mass, and non-fat mass will be monitored non-invasively using a weigh scale and densitometry via air displacement (Bod Pod) at 0, 2 and 4 weeks following the dietary intervention. Also, participants will be interviewed following the final body composition measure to assess whether or not they continued to follow the intermittent fasting approach.
Read the detailed description
Participants (16 overweight women, BMI (Body mass index) ˃25, ages 18- 30 y)will complete a one-month intervention where they will restrict their daily food intake to an 8-hour time period, i.e., between 1200 to 2000 hours. During the remaining 16-hour intermittent fasting period (2000 to 1200 hours) participants will be allowed to drink zero calorie beverages (diet soda pop, black coffee, tea, water, etc) in order to maintain normal hydration. There will be no attempt to restrict food intake. Rather simply to restrict the time period each day when food is consumed. Participants' fat mass will be monitored non-invasively using densitometry (with a Bod Pod) prior to and following a 4 week intervention where the participants will eat their normal daily intake during an 8-hour period each day (1200 to 2000 hours). The Bod Pod measures body volume via air displacement and together with an accurate measure of body mass enables body density to be calculated (Density = mass/volume). Satisfaction, hunger, and fullness with the diet will be monitored on a weekly basis using a validated visual analog scale (Flit et al, 2000). Adherence to the diet will also be assessed on a weekly basis as the number of days the diet was followed. During the 16-hour fasting period participants will be able to drink as much of zero calorie beverages as they desire. On day 2, 7, 14, 21, \& 28 participants will return to the lab at 8am (following a 12 hour fasting period) and both the acidity of their urine (using a urine dip stick) and their blood sugar (using a glucometer) will be tested. Following one month the participants will be allowed either to continue this eating pattern or revert to their prior 3 meal intake. After a month of self-regulation, the participants' fat mass will be measured again using the Bod Pod.
- Conditions
- Weight Loss
- Being tested
- Time restricted feeding
- Keywords
- Weight Loss, Intermittent fasting
- Medical subject headings
- Weight Loss, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time restricted feedingBehavioural
Participants will consume their daily calories only between 12:00 and 20:00 for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intermittent fasting group | Experimental | Participants will restrict their daily food intake (time restricted feeding) to an 8-hour time period between 1200 to 2000 hours. During the remaining 16-hour intermittent fasting period (2000 to 1200 hours) participants will be allowed to drink zero calorie beverages (diet soda pop, black coffee, tea, water, etc) in order to maintain normal hydration. There will be no attempt to restrict food intake. Rather simply to restrict the time period each day when food is consumed. Receives: Behavioral: Time restricted feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat mass change over 4 weeks period of intervention
Body fat mass change (%) will be measured using BodPod over the course of 4 weeks at 0, 2 and 4 weeks
Measured: 4 weeks
Secondary outcomes (6)
Non-fat mass change over 4 weeks period of intervention
Body non-fat mass (lean mass) (%) will be measured using BodPod over the course of 4 weeks at 0, 2 and 4 weeks
Measured: 4 weeks
Urine acidity change over 4 weeks of intervention
Urine acidity will be measured following a 12 hours fasting at 0800 using a urine dip stick on days 2, 7, 14, 21, \& 28
Measured: 4 weeks
Blood sugar change over 4 weeks of intervention
Fasted blood sugar will be measured following a 12 hours fasting at 0800 using a finger prick glucometer (Free Style Lite) on days 2, 7, 14, 21, \& 28
Measured: 4 weeks
Diet satisfaction change over 4 weeks of intervention
Diet satisfaction will be monitored on a weekly basis using a validated visual analog scale (Flit et al, 2000)
Measured: 4 weeks
Feeling of hunger change over 4 weeks of intervention
Hunger will be monitored on a weekly basis using a validated visual analog scale (Flit et al, 2000)
Measured: 4 weeks
Feeling of fullness change over 4 weeks of intervention
Feeling of fullness will be monitored on a weekly basis using a validated visual analog scale (Flit et al, 2000)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Western Ontario, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Lemon, University of Western Ontario, Canada
- Investigators
- Peter Lemon, PhD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02629900
- Sponsor's protocol ID
- 107401
- Status last verified
- Jan 2016
- First submitted
- 10 Dec 2015
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Time Restricted Feeding on Fat Mass in Overweight Women
- ClinicalTrials.gov ID
- NCT02629900
- Acronym / sponsor ID
- 107401
- Conditions
- Weight Loss
- Keywords
- Weight Loss, Intermittent fasting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of Western Ontario, CanadaUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 14 Dec 2015 (estimated)
- 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.
Participants will complete a one-month intervention where they are will restrict their daily food intake to an 8-hour time period, i.e., between 1200 to 2000 hours. During the remaining 16-hour intermittent fasting period (2000 to 1200 hours) participants will be allowed to drink zero calorie beverages (diet soda pop, black coffee, tea, water, etc) in order to maintain normal hydration. There will be no attempt to restrict food intake. Rather simply to restrict the time period each day when food is consumed. Participants' body mass, fat mass, and non-fat mass will be monitored non-invasively using a weigh scale and densitometry via air displacement (Bod Pod) at 0, 2 and 4 weeks following the dietary intervention. Also, participants will be interviewed following the final body composition measure to assess whether or not they continued to follow the intermittent fasting approach.
Detailed description
Participants (16 overweight women, BMI (Body mass index) ˃25, ages 18- 30 y)will complete a one-month intervention where they will restrict their daily food intake to an 8-hour time period, i.e., between 1200 to 2000 hours. During the remaining 16-hour intermittent fasting period (2000 to 1200 hours) participants will be allowed to drink zero calorie beverages (diet soda pop, black coffee, tea, water, etc) in order to maintain normal hydration. There will be no attempt to restrict food intake. Rather simply to restrict the time period each day when food is consumed. Participants' fat mass will be monitored non-invasively using densitometry (with a Bod Pod) prior to and following a 4 week intervention where the participants will eat their normal daily intake during an 8-hour period each day (1200 to 2000 hours). The Bod Pod measures body volume via air displacement and together with an accurate measure of body mass enables body density to be calculated (Density = mass/volume). Satisfaction, hunger, and fullness with the diet will be monitored on a weekly basis using a validated visual analog scale (Flit et al, 2000). Adherence to the diet will also be assessed on a weekly basis as the number of days the diet was followed. During the 16-hour fasting period participants will be able to drink as much of zero calorie beverages as they desire. On day 2, 7, 14, 21, \& 28 participants will return to the lab at 8am (following a 12 hour fasting period) and both the acidity of their urine (using a urine dip stick) and their blood sugar (using a glucometer) will be tested. Following one month the participants will be allowed either to continue this eating pattern or revert to their prior 3 meal intake. After a month of self-regulation, the participants' fat mass will be measured again using the Bod Pod.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intermittent fasting group | Experimental | Behavioral: Time restricted feedingParticipants will restrict their daily food intake (time restricted feeding) to an 8-hour time period between 1200 to 2000 hours. During the remaining 16-hour intermittent fasting period (2000 to 1200 hours) participants will be allowed to drink zero calorie beverages (diet soda pop, black coffee, tea, water, etc) in order to maintain normal hydration. There will be no attempt to restrict food intake. Rather simply to restrict the time period each day when food is consumed. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Asymptomatic participants between the ages of 18-30 years with body mass index ˃25 will be studied
Key exclusion criteria (7 listed)
- Diabetic
- Pregnant
- Individuals with a history of fainting
- Low blood sugar
- Heart disease, migranes, or heart burn
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 feedingParticipants will consume their daily calories only between 12:00 and 20:00 for 4 weeks | Behavioural | Intermittent fasting group |
Primary outcome
Fat mass change over 4 weeks period of intervention
Time frame: 4 weeks
Body fat mass change (%) will be measured using BodPod over the course of 4 weeks at 0, 2 and 4 weeks
6 secondary outcomes
Non-fat mass change over 4 weeks period of intervention
Time frame: 4 weeks
Urine acidity change over 4 weeks of intervention
Time frame: 4 weeks
Blood sugar change over 4 weeks of intervention
Time frame: 4 weeks
Diet satisfaction change over 4 weeks of intervention
Time frame: 4 weeks
Feeling of hunger change over 4 weeks of intervention
Time frame: 4 weeks
Feeling of fullness change over 4 weeks of intervention
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
- Individual participant dataSharing planned: No
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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.
Siobhan Smith, Bsc contact
Peter Lemon, PhD principal investigator
Western University
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 feeding in people with Weight Loss, run by University of Western Ontario, 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 1 inclusion and 7 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 20 Jan 2016. 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 Lemon, PhD (1 519 661 2111 ext. 88139, plemon@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat mass change over 4 weeks period of intervention (time frame: 4 weeks). 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 20 Jan 2016.