Time Restricted Eating in Sleep Apnea

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT06047496
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Obstructive Sleep Apnea
  • Time Restricted Eating

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Time restricted eating — BEHAVIORAL
    Caloric intake restricted to a self-defined 8-10 hour window in each 24-hour period.

Study Details

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.

Key Dates

Start date
Jan 5, 2024
Status verified
Jan 2024
Primary completion
Jul 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Effect of TRE vs SE on change in mean daily glucose level [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California San Diego (ACTRI)La JollaCalifornia92037
Omar Mesarwi, MD
[email protected]
858-822-1783

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By research site
University of California San Diego (ACTRI)· La Jolla, CA

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