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

NCT ID: NCT02629900

Last Updated: 2016-01-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-04-30

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Intermittent fasting group

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.

Group Type: EXPERIMENTAL

Time restricted feeding

Intervention Type: BEHAVIORAL

Participants will consume their daily calories only between 12:00 and 20:00 for 4 weeks

Interventions

Time restricted feeding

Participants will consume their daily calories only between 12:00 and 20:00 for 4 weeks

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Western Ontario, Canada

OTHER

Sponsor Role: lead

Responsible Party

Peter Lemon

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter Lemon, PhD

Role: PRINCIPAL_INVESTIGATOR

Western University

Locations

Exercise Nutrition Research Laboratory, Western University

London, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Peter Lemon, PhD

Role: CONTACT

plemon@uwo.ca

1 519 661 2111 ext. 88139

Siobhan Smith, Bsc

Role: CONTACT

ssmit422@uwo.ca

Facility Contacts

Peter Lemon, PhD

Role: primary

plemon@uwo.ca

519 661 2111 ext. 88139

Other Identifiers

107401

Identifier Type: -

Identifier Source: org_study_id