An interventional study of Time-restricted eating in Time-Restricted Eating (16:8) and Fasting, sponsored by Western University, Canada. Status unknown at 1 site in Canada. Open to participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-07.
Sponsored by Western University, Canada · Not applicable, Interventional, and Treatment
This study will examine the effect of eating timing on body composition. Previous studies have shown that restricting food intake to 8 hours a day can result in losses in body fat and an up-regulation of fat use. The purpose of this study is to assess changes in body composition when the eating window time is from 6am-2pm vs 2pm-10pm.
Hypothesis: The 2-10pm eating window will result in significantly greater changes in body composition (i.e. decreased fat mass) and the 2pm-10pm window will result in better adherence.
Methods: Body composition (fat and lean mass) will be assessed by air displacement densitometry (Bod Pod). Measures will be made over 4 weeks (pre-) and (post) dietary treatment. Adherence will also be assessed by a questionnaire to determine the ease/difficulty of the treatment.
Purpose The purpose of the study is to determine whether the eating window of a time-restricted eating protocol affects changes in body composition. It is hypothesized that the afternoon group will have better adherence to their experimental protocol and have greater changes in body composition.
Sample The sample will include 20 healthy adult participants ranging in age from 18-25 that volunteer to participate in the study. Participants will be required to have a body mass index above 26 (BMI=weight(kg)/height(m)2). All individuals must give written informed consent in order to participate in the study. Exclusion criteria include a history of intermittent fasting in the past 6 months, diabetes, or pregnancy and BMI less than 25.9.
Procedure Inclusion/exclusion criteria will be explicitly stated throughout the recruitment process. Potential participants will be recruited through advertising using posters placed through the University of Westerns campus as well as via presentations in classrooms (using the information from the advertising flyers). Individuals who email Bryce Knapp will be invited to a meeting to discuss the study. After the evaluation and information meeting, the individual will be given up to 3 days to determine if they want to participate and give their informed consent. See attached form in the consent section of the ethics application.
Measurement: All individuals will have their body composition measured. Body composition will be measured using air displacement densitometry "Bod Pod". Measurements will be taken twice prior to the intervention and twice on successive days post-intervention. Individuals will also be asked to fill out a biweekly modified dialysis diet and fluid non-adherence questionnaires (DDFQ) with added checkboxes to record which days they complied with the required protocol and 2 questions regarding any struggles the participants experienced. This will be used to assess the adherence to the protocols.
Protocol: 20 participants matched for BMI will be assigned to one of two groups. The two groups will be assigned an eating period of 6am-2pm or 2pm-10pm and instructed not to ingest calories outside of their respective eating window. The interventions will last 4 weeks with individuals being asked to comply to their eating window a minimum of 5 days per week. This will be measured using the modified DDFQ. All testing will be completed by Bryce Knapp under the supervision of Dr. Lemon. The changes in fat mass will be analyzed using a 2-way ANOVA and the adherence will be measured using an independent t-test.
333 studies on the registry are indexed under Intermittent Fasting; 99 are open to participants now.
This study's planned enrollment of 20 is below the median of 50 across 320 interventional studies indexed under Intermittent Fasting.
Browse Intermittent Fasting studies →Western University, Canada is the lead sponsor of 224 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
4 weeks of time restricted eating between 6am-2pm.
Other: Time-restricted eating
4 weeks of time restricted eating between 2pm-10pm.
Other: Time-restricted eating
Groups will be required to only ingest calories in their designated 8 hour eating window.
Also known as: Intermittent Fasting
Change in Fat mass using "Bod Pod"
Measuring the change in fat mass between the two groups using air displacement densitometry "Bod Pod"
Time frame: 4 weeks
Adherence using the dialysis diet and fluid non-adherence questionnaire.
Measuring adherence of the two groups using the DDFQ non adherence questionaire
Time frame: 4 weeks
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Start is estimated for Jan 2018; primary completion for Feb 2018, 1 month later.
Of 257 non-industry interventional studies with no phase under Intermittent Fasting, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 34. This study's planned 1 month is below that.
Counting every sponsor, half of 263 studies reached it within 17 months; a quarter within 8 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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