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Clinical Trials/NCT02413866
NCT02413866CompletedNot Applicable

Weight Outlooks by Restriction of Diet and Sleep

University of South Carolina2 sites in 1 country36 target enrollmentStarted: January 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
36
Locations
2
Primary Endpoint
body composition measured via DXA scans

Study Overview

Brief Summary

The purpose of this study is to examine whether chronic moderate sleep restriction effects the amount of body fat and lean mass loss, and calorie expenditure, in individuals who are participating in a dietary weight loss program.

Detailed Description

Participants will be randomly assigned to an 8-week program of either restricted diet alone, or restricted diet with restricted sleep for 5 days a week. The total expected duration of participation is approximately 3 months.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
35 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • age between 35-55 years,
  • BMI between 30-35 kg/meters squared,
  • total sleep time between 6.5-8 hours

Exclusion Criteria

  • work requiring changing schedule,
  • use of sleep aids or sleep medication

Arms & Interventions

Calorie Restriction Only

Experimental

Participants in this group will be decreasing their caloric intake to approximately 95% of their resting metabolic rate. We will provide one meal for 4 days of the week, and participants will be required to keep an accurate dietary record of all food and drink. Participants assigned to this group will be instructed to keep a fixed sleep schedule based on their own sleep/napping habits.

Intervention: Calorie restriction only (Behavioral)

Sleep & Calorie Restriction

Experimental

Participants in this group will decrease their caloric intake to approximately 95% of their resting metabolic rate in addition to reducing their total time in bed by 90 minutes 5 days a week.

Intervention: Sleep & calorie restriction (Behavioral)

Outcomes

Primary Outcomes

body composition measured via DXA scans

Time Frame: 4 months

Body composition will be measured via DXA scans prior to intervention and post intervention to compare losses in lean body mass and fat mass.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Xuewen Wang

Assistant Professor

University of South Carolina

Study Sites (2)

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