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OpenTrials
Completed

NCT Number: NCT02413866

Weight Outlooks by Restriction of Diet and Sleep

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.

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Key information

Conditions

Weight Body Weight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

35 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Carolina

Columbia, South Carolina, 29208, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Calorie restriction only

Behavioral

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

Behavioral

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Registry information

Acronym: WORDS

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 10, 2015
Registry last updated
Apr 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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