NCT02413866

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 10, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

April 19, 2019

Status Verified

December 1, 2016

Enrollment Period

1.8 years

First QC Date

April 7, 2015

Last Update Submit

April 17, 2019

Conditions

Keywords

body compositionanthropometry

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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.

Behavioral: Calorie restriction only

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.

Behavioral: Sleep & calorie restriction

Interventions

Participants randomly assigned to this group will be instructed to reduce their daily energy intake to 95% of their resting metabolic rate.

Calorie Restriction Only

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.

Sleep & Calorie Restriction

Eligibility Criteria

Age35 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

Related Publications (2)

  • Sparks JR, Porter RR, Youngstedt SD, Bowyer KP, Durstine JL, Wang X. Effects of moderate sleep restriction during 8-week calorie restriction on lipoprotein particles and glucose metabolism. Sleep Adv. 2021 Jan 28;1(1):zpab001. doi: 10.1093/sleepadvances/zpab001. eCollection 2020.

  • Wang X, Sparks JR, Bowyer KP, Youngstedt SD. Influence of sleep restriction on weight loss outcomes associated with caloric restriction. Sleep. 2018 May 1;41(5):10.1093/sleep/zsy027. doi: 10.1093/sleep/zsy027.

MeSH Terms

Conditions

Body Weight

Interventions

Sleep

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Xuewen Wang, PhD

    University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 7, 2015

First Posted

April 10, 2015

Study Start

January 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

April 19, 2019

Record last verified: 2016-12

Locations