Circadian Intervention to Improve Cardiometabolic Health
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Circadian Intervention.
- Who it may be relevant to
- Registry conditions: Cardiometabolic Syndrome, Type 2 Diabetes, Sleep, Time Restricted Feeding. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Timing of Circadian Synchronizers: The TOCS Study
Overview
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.
Interventions
- Behavioral Circadian Intervention
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 measures
- Insulin sensitivity change from baseline [Time frame: Change from baseline to end of the ~8 week experimental segment]
Secondary outcome measures (7)
- Timing of central circadian clock change from baseline [Time frame: Change from baseline to end of the ~8 week experimental segment]
- Plasma ceramides change from baseline [Time frame: Change from baseline to end of the ~8 week experimental segment]
- Average (per week) nightly total sleep time change from baseline [Time frame: Analyzed as change from baseline for each week of the ~8 week experimental segment]
- Average (per week) sleep satisfaction change from baseline [Time frame: Analyzed as change from baseline for each week of the ~8 week experimental segment]
- Average (per week) self-reported sleep duration change from baseline [Time frame: Analyzed as change from baseline for each week of the ~8 week experimental segment]
- Average (per week) timing of food intake change from baseline [Time frame: Change from baseline to week 8 of the ~8 week experimental segment]
- Average (per week) daytime alertness change from baseline [Time frame: Analyzed as change from baseline for each week of the ~8 week experimental segment]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- College of Health Research Complex--University of Utah — Salt Lake City
Identifiers
NCT: NCT05943626 · 22-60