Time Restricted Eating for Sleep Apnea
(TERESA Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: University of California, San Diego
Must not be taking: Insulin, Sulfonylureas, Appetite suppressants, others
Disqualifiers: Diabetes, BMI >40, Hypertension, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you are on cardiovascular medications like statins or blood pressure drugs, you must keep the same dose during the study.
What data supports the effectiveness of the treatment Time Restricted Eating for Sleep Apnea?
Research suggests that time-restricted eating (TRE) can help reduce body weight and improve energy metabolism, which are factors that might indirectly benefit sleep apnea. Although direct effects on sleep apnea are not yet confirmed, TRE has been shown to maintain good sleep quality in people with obesity, which could be relevant for sleep apnea management.12345
Is time-restricted eating safe for humans?
How is time-restricted eating different from other treatments for sleep apnea?
Time-restricted eating (TRE) is unique because it focuses on limiting the hours during which you eat each day, aligning with your body's natural circadian rhythms, rather than using medications or devices. This approach may help improve sleep quality and energy metabolism without affecting total energy expenditure, offering a novel way to manage sleep apnea by potentially reducing body weight and improving sleep patterns.110111213
Eligibility Criteria
This trial is for adults aged 18-70 with untreated moderate to severe obstructive sleep apnea (OSA). Participants must be willing to follow the study procedures, own a smartphone, and have an eating period of over 12 hours per day. They cannot change doses of any cardiovascular medications during the study.Inclusion Criteria
I am willing and able to follow all study rules and attend all appointments.
I have moderate to severe sleep apnea that hasn't been treated.
You commit to following the Lifestyle Considerations throughout the study.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2 weeks
1 visit (in-person)
Baseline
Participants maintain their current lifestyle and record dietary intake using the mCC app
2 weeks
1 visit (in-person)
Treatment
Participants follow either time restricted eating or standard eating for 12 weeks
12 weeks
6 visits (virtual), 2 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- Time Restricted Eating (Behavioral Intervention)
Trial OverviewThe trial is testing if time restricted eating (TRE) can improve glucose regulation and cardiovascular health in OSA patients compared to standard eating habits. It involves following a TRE plan for 12 weeks and uses smartphones for tracking.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Time restricted eatingExperimental Treatment1 Intervention
Caloric intake restricted to a self-defined 8-10 hour window in each 24-hour period, for 12 weeks.
Group II: Standard eatingActive Control1 Intervention
Normal eating schedule. Participants are expected to maintain their normal eating and dietary habits.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of California San Diego (ACTRI)La Jolla, CA
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Who Is Running the Clinical Trial?
University of California, San DiegoLead Sponsor
References
Meal Timing and Sleeping Energy Metabolism. [2023]There is a physiological link between sleep and eating. Insufficient sleep is a risk factor for overeating and excess body weight gain, and molecules such as orexin and insulin play a role in the control of sleep and energy intake. The effects of dietary timing on sleep and energy metabolism were examined in this review. First, we examined sleep energy metabolism and sleep quality under time-restricted eating, including skipping breakfast or dinner. Second, the mechanisms, benefits, and translational potential of the effects of time-restricted diets on sleep were discussed. Time-restricted eating under controlled conditions, in which daily caloric intake was kept constant, affected the time course of energy metabolism but did not affect total energy expenditure over 24 h. In free-living conditions, time-restricted eating for extended durations (4-16 weeks) decreased energy intake and body weight, and the effects of early time-restricted eating were greater than that of midday time-restricted eating. Although assessment of sleep by polysomnographic recording remains to be performed, no negative effects on the subjective quality of sleep have been observed.
Early time-restricted eating advances sleep in late sleepers: a pilot randomized controlled trial. [2023]This study evaluated the effects of early time-restricted eating (eTRE) on shifting the timing of sleep among late sleepers. Primary outcomes included actigraphy- and sleep diary-derived sleep onset, midsleep phase, and wake time with total sleep time as a secondary outcome.
Effect of 8-h time-restricted feeding on sleep quality and duration in adults with obesity. [2020]This study examined the effects of time-restricted feeding (TRF; 8-h feeding window/16-h fasting window daily) on sleep. Obese adults (n = 23) followed 8-h TRF for 12 weeks. Pittsburgh Sleep Quality Index (PSQI) total score was below 5 at week 1 (4.7 ± 0.5) and week 12 (4.8 ± 0.7), indicating good sleep quality throughout the trial. Subjective measures of wake time, bedtime, and sleep duration remained unchanged. Findings from this secondary analysis indicate that TRF does not alter sleep quality or duration in subjects with obesity. Novelty This study is the first to show that TRF (8-h feeding window/16-h fasting window daily) does not alter sleep quality or duration in subjects with obesity.
Complex physiology and clinical implications of time-restricted eating. [2023]Time-restricted eating (TRE) is a dietary intervention that limits food consumption to a specific time window each day. The effect of TRE on body weight and physiological functions has been extensively studied in rodent models, which have shown considerable therapeutic effects of TRE and important interactions among time of eating, circadian biology, and metabolic homeostasis. In contrast, it is difficult to make firm conclusions regarding the effect of TRE in people because of the heterogeneity in results, TRE regimens, and study populations. In this review, we 1) provide a background of the history of meal consumption in people and the normal physiology of eating and fasting; 2) discuss the interaction between circadian molecular metabolism and TRE; 3) integrate the results of preclinical and clinical studies that evaluated the effects of TRE on body weight and physiological functions; 4) summarize other time-related dietary interventions that have been studied in people; and 4) identify current gaps in knowledge and provide a framework for future research directions.
Fiber and Saturated Fat Are Associated with Sleep Arousals and Slow Wave Sleep. [2022]Sleep restriction alters food intake, but less is known about how dietary patterns affect sleep. Current goals were to determine whether: (1) sleep is different after consumption of a controlled diet vs. an ad libitum diet, and (2) dietary intake during ad libitum feeding is related to nocturnal sleep.
Safety of 8-h time restricted feeding in adults with obesity. [2019]This study examines the safety of time restricted feeding (TRF; 8-h feeding window/16-h fasting window daily) in obese adults. Twenty-three subjects participated in an 8-h TRF intervention for 12 weeks. Self-reported adverse events, body image perception, complete blood count, and disordered eating patterns did not change from baseline to week 12. These findings suggest that consuming food within an 8-h window can safely facilitate weight loss in subjects with obesity.
Effects of 4- and 6-h Time-Restricted Feeding on Weight and Cardiometabolic Health: A Randomized Controlled Trial in Adults with Obesity. [2022]Time-restricted feeding (TRF) regimens have grown in popularity; however, very few studies have examined their weight-loss efficacy. We conducted the first human trial (Clinicaltrials.gov NCT03867773) to compare the effects of two popular forms of TRF (4 and 6 h) on body weight and cardiometabolic risk factors. Adults with obesity were randomized to 4-h TRF (eating only between 3 and 7 p.m.), 6-h TRF (eating only between 1 and 7 p.m.), or a control group (no meal timing restrictions). After 8 weeks, 4- and 6-h TRF produced comparable reductions in body weight (∼3%), insulin resistance, and oxidative stress, versus controls. Energy intake was reduced by ∼550 kcal/day in both TRF groups, without calorie counting. These findings suggest that 4- and 6-h TRF induce mild reductions in body weight over 8 weeks and show promise as interventions for weight loss. These diets may also improve some aspects of cardiometabolic health.
Identification of factors influencing motivation to undertake time-restricted feeding in humans. [2021]The interaction between time of day and energy intake, termed chrono-nutrition, has received considerable recent interest. One aspect of chrono-nutrition with potential to benefit long-term cardio-metabolic health is time-restricted feeding (TRF). Current support for TRF primarily derives from animal research, although recent small-scale human studies indicate possible translational benefit. Whether free-living humans, however, can incorporate TRF into their daily lives is poorly understood. This study reports data from participants (n = 608) who completed an online questionnaire to investigate daily routine, likelihood of TRF incorporation within work vs free-days, and key considerations influencing TRF uptake. The majority of participants reported a typical daily feeding window (time between first and last energy intake) of between 10 and 14 h on workdays and free days, 62.7 and 65.5% respectively. Likelihood of adherence to TRF declined with an increase in the proposed restriction of the feeding window by 0.5 to 4-h per day. We then examined data from participants with a typical daily feeding window of 12+ h on workdays (n = 221) and free-days (n = 223) to investigate the likelihood of using TRF, and the most important considerations in making this decision. Of these participants, (n = 132) on workdays and (n = 125) on free days would likely reduce their feeding window by 3-h. Multiple regression analysis revealed that key considerations determining the likelihood of adopting TRF were: cost, time availability, and perceived health benefits (on workdays); wake time, bed time, time availability, motivation to change and perceived health benefits (on free-days). These data provide novel information regarding public attitudes towards TRF and highlight important aspects to be considered when translating controlled laboratory studies to public dietary advice.
[Time-restricted eating as a novel strategy for treatment of obesity and it's comorbid conditions]. [2023]The article provides a review of the current literature about time-restricted eating (TRE) as a new tool for the treatment of obesity and comorbid conditions. The search for new nutritional strategies in obesity, one of which is TRE, is due to the weak adherence of patients to hypocaloric diets in the long term, as well as the available data on the importance of -desynchronization of food intake with natural circadian rhythms in the development and progression of obesity and cardio--metabolic complications. The article describes the main mechanisms that regulate the circadian rhythms of food intake and nutrient absorption, substantiates the importance of adhering to a physiological diet for maintaining metabolic health. The main part of the review is devoted to reviewing the currently available researches on the effectiveness of various strategies of intermittent energy restriction for weight loss and the correction of metabolic parameters. Potential mechanisms of the -effect of TRE on health are discussed, including those mediated by an unintentional decrease in caloric intake and changes in eating behavior, and differences in the effectiveness of early and late TRE. The article contains a detailed discussion of the potential problems and contradictions associated with the use of time-restricted eating in clinical practice, namely: the limitations and inconsistencies of the available clinical trials, the lack of data on long-term efficacy and safety, social and psychological limitations that impede the widespread use of TRE.
Effect of time restricted feeding on the gut microbiome in adults with obesity: A pilot study. [2022]Time restricted feeding is a form of intermittent fasting where participants shorten the daily window in which they eat.
The effect of 4-h versus 6-h time restricted feeding on sleep quality, duration, insomnia severity and obstructive sleep apnea in adults with obesity. [2022]Time restricted feeding (TRF) involves deliberately restricting the times during which energy is ingested. Preliminary findings suggest that 8-10-h TRF improves sleep. However, the effects of shorter TRF windows (4-6 h) on sleep, remain unknown.
Changes in body weight and metabolic risk during time restricted feeding in premenopausal versus postmenopausal women. [2023]Time restricted feeding (TRF) involves confining the eating window to a specific number of hours, and fasting for the remaining hours of the day.
Time-restricted eating alters the 24-hour profile of adipose tissue transcriptome in men with obesity. [2023]Time-restricted eating (TRE) restores circadian rhythms in mice, but the evidence to support this in humans is limited. The objective of this study was to investigate the effects of TRE on 24-hour profiles of plasma metabolites, glucoregulatory hormones, and the subcutaneous adipose tissue (SAT) transcriptome in humans.