Circadian Intervention to Improve Cardiometabolic Health

NCT05943626 | Recruiting DMC

• 1 other identifier: 22-60
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Cardiometabolic Syndrome; Type 2 Diabetes; Sleep; Time Restricted Feeding; Lifestyle Factors; Overweight and Obesity; Insulin Sensitivity; Eating Habit; Sleep Hygiene

Outcome Measures

Primary Outcomes (1)

• Insulin sensitivity change from baseline

  Oral Glucose Tolerance Test (OGTT), Matsuda Index

  Change from baseline to end of the ~8 week experimental segment

Secondary Outcomes (7)

• Timing of central circadian clock change from baseline

  Change from baseline to end of the ~8 week experimental segment

• Plasma ceramides change from baseline

  Change from baseline to end of the ~8 week experimental segment

• Average (per week) nightly total sleep time change from baseline

  Analyzed as change from baseline for each week of the ~8 week experimental segment

• Average (per week) sleep satisfaction change from baseline

  Analyzed as change from baseline for each week of the ~8 week experimental segment

• Average (per week) self-reported sleep duration change from baseline

  Analyzed as change from baseline for each week of the ~8 week experimental segment

Study Arms (2)

Control Group

NO INTERVENTION

Provided with general health information on diet and physical activity.

Intervention Group

EXPERIMENTAL

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

Behavioral: Circadian Intervention

Interventions

Circadian Intervention BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

College of Health Research Complex--University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome; Diabetes Mellitus, Type 2; Intermittent Fasting; Overweight; Obesity; Insulin Resistance; Feeding Behavior; Sleep Hygiene

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases; Fasting; Behavior; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Health Behavior

Central Study Contacts

Christopher M Depner, PhD

CONTACT

801-581-2275; christopher.depner@utah.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Group allocation will be blinded to research staff and participants until the conclusion of the baseline segment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: July 13, 2023
• Study Start: June 13, 2023
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)