The Effect of Time Restricted Feeding on Fat Mass in Overweight Women

Weight Loss Clinical Trial

Official title:

The Effect of Time Restricted Feeding on Fat Mass in Overweight Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02629900
• Other study ID #: 107401
• Status: Recruiting
• Phase: N/A
• First received: December 10, 2015
• Last updated: January 18, 2016
• Start date: January 2016
• Est. completion date: April 2016

Study information

• Verified date: January 2016
• Source: University of Western Ontario, Canada
• Contact: Peter Lemon, PhD
• Phone: 1 519 661 2111
• Email: plemon[@]uwo.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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, 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Asymptomatic participants between the ages of 18-30 years with body mass index ?25 will be studied

Exclusion Criteria:

• 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Weight Loss

Intervention

Behavioral:
• Time restricted feeding
Participants will consume their daily calories only between 12:00 and 20:00 for 4 weeks

Locations

Country	Name	City	State
Canada	Exercise Nutrition Research Laboratory, Western University	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Western Ontario, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 weeks	No
Secondary	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	4 weeks	No
Secondary	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	4 weeks	No
Secondary	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	4 weeks	No
Secondary	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)	4 weeks	No
Secondary	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)	4 weeks	No
Secondary	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)	4 weeks	No