Recruiting
Early Phase 1

Time Restricted Eating

Sponsor:

UCLA

Code:

NCT06047496

Conditions

Time Restricted Eating

Obstructive Sleep Apnea

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Time restricted eating

Study Details

Brief summary:

Obstructive sleep apnea (OSA) is a highly prevalent disorder that is associated with both cardiovascular and metabolic dysfunction, such as hypertension, increased blood glucose levels and diabetes, obesity, and nonalcoholic fatty liver. While continuous positive airway pressure (CPAP), the best available OSA treatment, has been shown to improve blood pressure in OSA, it does not appear to improve metabolic consequences of OSA, and other therapies for OSA-induced dysmetabolism are needed. Animal models of time restricted eating (TRE) demonstrate an improvement in glucose and lipid metabolism, even in the absence of a reduction of caloric intake. Some human studies have shown an improvement in metabolic dysfunction with TRE, though further well-designed studies are needed. The effects of TRE on metabolic dysfunction in patients with OSA, a population with a high predisposition to metabolic disorder, has never been examined. In this study, we will conduct a randomized clinical trial to assess the feasibility and efficacy of 12 weeks of TRE, versus standard eating (SE), to improve glucose regulation and cardiovascular health of participants with OSA.

Conditions

Time Restricted Eating

Obstructive Sleep Apnea

Study ID

NCT06047496

Start date

Jan 5, 2024

Status verified date

Jan, 2024

Completion date

Dec, 2028

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Provision of signed and dated informed consent form;
  • Stated willingness to comply with all study procedures and availability for the duration of the study;
  • Be of appropriate age (18-70);
  • Own a smartphone (Apple iOS or Android OS);
  • Have a baseline eating period ≥12 hours/day and sufficient logging on the myCircadianClock app;
  • If participants are on cardiovascular medications (HMG CoA reductase inhibitors (statins), other lipid-modifying drugs, anti-hypertensives) no dose adjustments will be allowed during the study period;
  • Have untreated moderate to severe obstructive sleep apnea (OSA, apnea-hypopnea index ≥15 events/hr); and
  • Agree to adhere to Lifestyle Considerations (see section 5.3) throughout study duration\]

Exclusion Criteria:

  • Participants with type 1 or type 2 diabetes mellitus who are taking insulin or sulfonylureas, or any participant with a history of hypoglycemia unawareness
  • OSA with evidence of significant sleepiness, as defined by either a) Epworth Sleepiness Score ≥15, or b) motor vehicle accident due to excessive sleepiness within the past year
  • BMI >40 kg/m2
  • Uncontrolled hypertension
  • Active tobacco or illicit drug use
  • Pregnant or breastfeeding women
  • Currently enrolled in a weight-loss or weight-management program
  • Currently on a special or prescribed diet for other reasons (e.g., Celiac disease)
  • Currently taking any medication that is meant for weight loss, or has known effect on appetite suppression
  • History of eating disorder(s)
  • History of surgical intervention for weight management
  • Chronic kidney disease
  • Treatment for active inflammatory and/or rheumatologic disease and cancer
  • Unrevascularized cardiovascular disease
  • Liver cirrhosis and/or significant alterations in liver function
  • History of (a) thyroid disease requiring dose titration of thyroid replacement medication(s) within the past 3 months (i.e., hypothyroidism on a stable dose of thyroid replacement therapy is not an exclusion)
  • Shift workers with variable (e.g., occasionally nocturnal) hours
  • Traveling outside the US
  • History of HIV/AIDS
  • Uncontrolled psychiatric disorder
  • Other safety concern based on MD judgement

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Time restricted eating

Caloric intake restricted to a self-defined 8-10 hour window in each 24-hour period, for 12 weeks.

no intervention: Standard eating

Normal eating schedule. Participants are expected to maintain their normal eating and dietary habits.

Interventions

Time restricted eating

Caloric intake restricted to a self-defined 8-10 hour window in each 24-hour period.

Primary outcome measure

  • Effect of TRE vs SE on change in mean daily glucose level [ Time Frame: 12 weeks ]
  • Effect of TRE vs SE on change in serum LDL cholesterol [ Time Frame: 12 weeks ]
  • Effect of TRE vs SE on change in OSA severity [ Time Frame: 12 weeks ]
  • Effect of TRE on quality of life [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Pamela DeYoung, RPSGT

(858) 246-2154pdeyoung@health.ucsd.edu

Omar Mesarwi, MD

(858) 822-1783omesarwi@health.ucsd.edu

Locations

University of California San Diego (ACTRI)

Recruiting

La Jolla, California, United States, 92037

Contacts

Omar Mesarwi, MD

858-822-1783omesarwi@health.ucsd.edu

More Information

Sponsor

University of California, San Diego

Last update posted

Jan 16, 2024

Last verified

Jan, 2024

Keywords

  • hyperglycemia
  • intermittent fasting
  • sleep apnea
  • weight loss
  • hyperlipidemia
  • metabolic syndrome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2024-01-16.