Weight Outlooks by Restriction of Diet and Sleep

Weight Clinical Trial

— WORDS  

Official title:

Weight Outlooks by Restriction of Diet and Sleep

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02413866
• Other study ID #: Pro00036519
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: November 2016

Study information

• Verified date: December 2016
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Weight

Intervention

Behavioral:
• Calorie restriction only
Participants randomly assigned to this group will be instructed to reduce their daily energy intake to 95% of their resting metabolic rate.
• Sleep & calorie restriction
Participants randomly assigned to this group will be instructed to reduce their total time in bed by 90 minutes 5 days a week, in addition to restricting their dietary intake to approximately 95% of their resting metabolic rate.

Locations

Country	Name	City	State
United States	University of South Carolina	Columbia	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body composition measured via DXA scans	Body composition will be measured via DXA scans prior to intervention and post intervention to compare losses in lean body mass and fat mass.	4 months