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Circadian Intervention to Improve Cardiometabolic Health (TOCS)

Primary Purpose

Cardiometabolic Syndrome, Type 2 Diabetes, Sleep

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Circadian Intervention
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiometabolic Syndrome

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age: 18-45 years old; equal numbers of men and women Body mass index (BMI): 25.0-34.9 kg/m2, Sleep Habits: habitual self-reported average total sleep time (TST) <6.5 hours per night for prior 6 months Exclusion Criteria: Clinically diagnosed sleep disorder or major psychiatric illness Evidence of significant organ dysfunction or disease (e.g., diagnosed diabetes, cardiovascular disease, or kidney disease) Use of prescription drugs or substances known to influence sleep or glucose metabolism Shift-work: current or history of within last year Weight change: >10% of body weight over prior six months Experiencing menopause or post-menopausal Current enrollment in weight loss or physical activity program like the Diabetes Prevention Program Currently pregnant or planning to become pregnant, or currently lactating. Currently smoking Alcohol intake >3 drinks per day or >14 drinks per week

Sites / Locations

  • College of Health Research Complex--University of UtahRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Intervention Group

Arm Description

Provided with general health information on diet and physical activity.

Circadian-based intervention focused on timing of light exposure and food intake.

Outcomes

Primary Outcome Measures

Insulin sensitivity change from baseline
Oral Glucose Tolerance Test (OGTT), Matsuda Index

Secondary Outcome Measures

Timing of central circadian clock change from baseline
Quantified as dim-light melatonin onset from salivary melatonin samples
Plasma ceramides change from baseline
Fasting plasma samples will be analyzed for plasma ceramides using targeted metabolomics
Average (per week) nightly total sleep time change from baseline
Analyzed by wrist-actigraphy
Average (per week) sleep satisfaction change from baseline
5 point likert scale on daily sleep log (1 = very good; 5 = very poor)
Average (per week) self-reported sleep duration change from baseline
Daily electronic sleep logs will be used to track sleep and waketimes during the ambulatory monitoring phases of the study
Average (per week) timing of food intake change from baseline
Time of day 50% of calories are consumed collected by picture based food diaries. Average per week will consist of 2 weekdays and 1 weekend day for baseline and final week of intervention
Average (per week) daytime alertness change from baseline
5 point likert scale on daily sleep log (1= most alert; 5 = not alert at all)

Full Information

First Posted
June 12, 2023
Last Updated
October 9, 2023
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT05943626
Brief Title
Circadian Intervention to Improve Cardiometabolic Health
Acronym
TOCS
Official Title
Timing of Circadian Synchronizers: The TOCS Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 13, 2023 (Actual)
Primary Completion Date
March 2026 (Anticipated)
Study Completion Date
March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The overall goal is to examine the efficacy of a circadian intervention in people with overweight and obesity and habitual short sleep duration (HSSD). Participants will undergo a randomized controlled trial, with circadian intervention and control (healthy lifestyle) groups. The circadian intervention is designed to reduce nighttime light exposure and after-dinner snack food intake. Alternatively, the control group will receive basic health information (e.g., physical activity, goal setting, and nutrition when eating out).
Detailed Description
The study is a randomized controlled trial with control and circadian intervention groups. Group allocation will be blinded to research staff and participants until the conclusion of the baseline segment. The circadian intervention group will receive counseling and instruction to reduce evening and nighttime light exposure, increase morning room light and sunlight exposure, and complete all food consumption at least 4 hours before bedtime. Participants randomized to control will maintain their habitual food intake and sleep habits in their home environment for ~8 weeks. Both groups will have equal contact time with the study team. Prior to enrollment participants will complete an clinical overnight sleep disorders screening. Baseline consists of an ~1-week ambulatory real-world monitoring segment. Following baseline participants will be randomized to the control or intervention groups for the 8 week experimental segment. Throughout the study sleep duration will be monitored using an actiwatch wrist-device and a daily electronic sleep log. At the end of the baseline and experimental segments participants will complete overnight laboratory visits to assess insulin sensitivity and circadian timing by oral glucose tolerance test and dim light melatonin onset, respectively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiometabolic Syndrome, Type 2 Diabetes, Sleep, Time Restricted Feeding, Lifestyle Factors, Overweight and Obesity, Insulin Sensitivity, Eating Habit, Sleep Hygiene

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Group allocation will be blinded to research staff and participants until the conclusion of the baseline segment.
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Provided with general health information on diet and physical activity.
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Circadian-based intervention focused on timing of light exposure and food intake.
Intervention Type
Behavioral
Intervention Name(s)
Circadian Intervention
Intervention Description
The circadian intervention group will receive counseling and instruction to reduce evening and nighttime light exposure, increase morning room light and sunlight exposure, and to finish all food consumption at least 4 hours before bedtime.
Primary Outcome Measure Information:
Title
Insulin sensitivity change from baseline
Description
Oral Glucose Tolerance Test (OGTT), Matsuda Index
Time Frame
Change from baseline to end of the ~8 week experimental segment
Secondary Outcome Measure Information:
Title
Timing of central circadian clock change from baseline
Description
Quantified as dim-light melatonin onset from salivary melatonin samples
Time Frame
Change from baseline to end of the ~8 week experimental segment
Title
Plasma ceramides change from baseline
Description
Fasting plasma samples will be analyzed for plasma ceramides using targeted metabolomics
Time Frame
Change from baseline to end of the ~8 week experimental segment
Title
Average (per week) nightly total sleep time change from baseline
Description
Analyzed by wrist-actigraphy
Time Frame
Analyzed as change from baseline for each week of the ~8 week experimental segment
Title
Average (per week) sleep satisfaction change from baseline
Description
5 point likert scale on daily sleep log (1 = very good; 5 = very poor)
Time Frame
Analyzed as change from baseline for each week of the ~8 week experimental segment
Title
Average (per week) self-reported sleep duration change from baseline
Description
Daily electronic sleep logs will be used to track sleep and waketimes during the ambulatory monitoring phases of the study
Time Frame
Analyzed as change from baseline for each week of the ~8 week experimental segment
Title
Average (per week) timing of food intake change from baseline
Description
Time of day 50% of calories are consumed collected by picture based food diaries. Average per week will consist of 2 weekdays and 1 weekend day for baseline and final week of intervention
Time Frame
Change from baseline to week 8 of the ~8 week experimental segment
Title
Average (per week) daytime alertness change from baseline
Description
5 point likert scale on daily sleep log (1= most alert; 5 = not alert at all)
Time Frame
Analyzed as change from baseline for each week of the ~8 week experimental segment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age: 18-45 years old; equal numbers of men and women Body mass index (BMI): 25.0-34.9 kg/m2, Sleep Habits: habitual self-reported average total sleep time (TST) <6.5 hours per night for prior 6 months Exclusion Criteria: Clinically diagnosed sleep disorder or major psychiatric illness Evidence of significant organ dysfunction or disease (e.g., diagnosed diabetes, cardiovascular disease, or kidney disease) Use of prescription drugs or substances known to influence sleep or glucose metabolism Shift-work: current or history of within last year Weight change: >10% of body weight over prior six months Experiencing menopause or post-menopausal Current enrollment in weight loss or physical activity program like the Diabetes Prevention Program Currently pregnant or planning to become pregnant, or currently lactating. Currently smoking Alcohol intake >3 drinks per day or >14 drinks per week
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher M Depner, PhD
Phone
801-581-2275
Email
christopher.depner@utah.edu
Facility Information:
Facility Name
College of Health Research Complex--University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Depner
Phone
801-581-2275
Email
sleepstudyparticipant@utah.edu

12. IPD Sharing Statement

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Circadian Intervention to Improve Cardiometabolic Health

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