Time Restricted Eating for Sleep Apnea

(TERESA Trial)

Overseen By Omar Mesarwi, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of California, San Diego

Must not be taking: Insulin, Sulfonylureas, Appetite suppressants, others

Disqualifiers: Diabetes, BMI >40, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 12 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if time-restricted eating (TRE), where meals occur within an 8-10 hour window each day, can improve glucose regulation and cardiovascular health in individuals with obstructive sleep apnea (OSA). OSA often correlates with issues like high blood pressure and elevated blood sugar levels, which current treatments don't fully address. The trial will compare TRE to a standard eating schedule to assess effectiveness. It seeks participants with untreated moderate to severe OSA who typically eat over a 12-hour period each day. As an Early Phase 1 trial, this research focuses on understanding how TRE functions in people, offering participants a chance to contribute to groundbreaking insights.

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.

Is there any evidence suggesting that time restricted eating is likely to be safe for humans?

Research has shown that time-restricted eating (TRE) is generally safe and easy for most people to follow. In some studies, participants who tried TRE did not report negative effects on sleep, mood, or overall quality of life, indicating that TRE likely doesn't cause major problems in these areas.

Some early studies in humans suggest that TRE might help lower the risk of conditions like obesity, diabetes, and heart disease without causing harm. For example, one study with teenagers who ate only during an 8-hour window found no negative impact on their sleep compared to those who ate over a longer period.

Overall, current evidence suggests TRE is safe for people to try, with no significant negative effects reported in these studies. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for sleep apnea?

Researchers are excited about time-restricted eating for sleep apnea because it offers a non-invasive approach that differs from traditional treatments like CPAP machines and oral appliances. This method involves limiting eating to an 8-10 hour window each day, which may help regulate the body's internal clock, potentially improving sleep patterns naturally. Unlike conventional treatments that focus on mechanical or pharmaceutical interventions, time-restricted eating could provide a lifestyle-based solution that enhances overall health with minimal side effects.

What evidence suggests that time restricted eating might be an effective treatment for sleep apnea?

Research has shown that time-restricted eating (TRE) can improve how the body processes food and energy. Some studies with people have found that TRE can aid in weight loss and reduce body fat. Animal studies suggest that TRE might enhance the body's handling of sugar and fat, even without reducing food intake. These improvements are significant because obstructive sleep apnea (OSA) often links to issues like high blood sugar and obesity. This trial will compare TRE, where participants restrict caloric intake to a self-defined 8-10 hour window, with a standard eating schedule. Although more research is needed specifically for people with OSA, these early findings suggest that TRE might help address the metabolic issues related to this condition. ^{1 2 4 6 7}

Who Is on the Research Team?

Omar Mesarwi, MD

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Time Restricted Eating

Trial Overview

The 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.

How Is the Trial Designed?

Group I: Time restricted eating Experimental Treatment 1 Intervention

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

Group II: Standard eating Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Published Research Related to This Trial

In a study of 23 obese adults following an 8-hour time-restricted feeding (TRF) schedule for 12 weeks, sleep quality remained consistently good, as indicated by a Pittsburgh Sleep Quality Index score below 5 throughout the trial.

The research found that TRF did not change subjective measures of sleep duration or timing, suggesting that this dietary approach does not negatively impact sleep in individuals with obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of 8-h time-restricted feeding on sleep quality and duration in adults with obesity. Gabel, K., Hoddy, KK., Burgess, HJ., et al.[2020]

In a study of 26 normal weight adults, consuming a controlled diet did not change sleep duration compared to a day of self-selected eating, but the latter resulted in less restorative sleep, characterized by reduced slow wave sleep (SWS) and longer time to fall asleep.

Dietary patterns significantly influenced sleep quality, with higher fiber intake linked to more SWS and lower intake of saturated fats and sugars associated with lighter sleep and more nighttime awakenings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fiber and Saturated Fat Are Associated with Sleep Arousals and Slow Wave Sleep. St-Onge, MP., Roberts, A., Shechter, A., et al.[2022]

In a 12-week study involving 14 adults with obesity, time-restricted feeding (8-hour eating window) led to a significant weight loss of about 2 kg, indicating potential efficacy for weight management.

Despite the weight loss, the study found no significant changes in the diversity or composition of the gut microbiome, suggesting that time-restricted feeding may not impact gut health in terms of microbial diversity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of time restricted feeding on the gut microbiome in adults with obesity: A pilot study. Gabel, K., Marcell, J., Cares, K., et al.[2022]

A study involving 608 participants found that most people typically eat within a 10 to 14-hour window on both workdays and free days, indicating a common pattern of energy intake.

The likelihood of adopting time-restricted feeding (TRF) decreases as the proposed feeding window restriction increases, with key factors influencing this decision being cost, time availability, and perceived health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of factors influencing motivation to undertake time-restricted feeding in humans. Jefcoate, PW., Robertson, MD., Ogden, J., et al.[2021]

Time-restricted eating (TRE) is emerging as a promising strategy for treating obesity and related health issues, addressing the challenges of long-term adherence to traditional hypocaloric diets.

While TRE may help with weight loss and metabolic health through mechanisms like reduced caloric intake and improved eating behaviors, there are significant limitations in current research, including inconsistencies in clinical trials and a lack of long-term safety data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Time-restricted eating as a novel strategy for treatment of obesity and it's comorbid conditions]. Berkovskaya, MA., Gurova, OY., Khaykina, IA., et al.[2023]

In a study involving 15 healthy adults who typically sleep late, early time-restricted eating (eTRE) significantly advanced their sleep timing, with participants reporting an earlier sleep onset by an average of 56.1 minutes compared to a control group.

Both self-reported and objectively measured sleep metrics (onset, midpoint, and offset) improved with eTRE, suggesting it could be an effective clinical strategy for helping late sleepers adjust their sleep schedules.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early time-restricted eating advances sleep in late sleepers: a pilot randomized controlled trial. Blum, DJ., Hernandez, B., Zeitzer, JM.[2023]

Time-restricted eating (TRE) has shown promising therapeutic effects in rodent studies, particularly in relation to body weight and metabolic health, but results in humans are inconsistent due to varying study designs and populations.

This review highlights the need for more standardized research on TRE in humans to better understand its effects and interactions with circadian biology, as well as to identify gaps in current knowledge for future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complex physiology and clinical implications of time-restricted eating. Petersen, MC., Gallop, MR., Flores Ramos, S., et al.[2023]

In a study of 49 adults with obesity, both 4-hour and 6-hour time-restricted feeding (TRF) led to significant weight loss (around 3.4 to 3.9 kg) over 8 weeks, but did not improve sleep quality or duration compared to a control group.

Neither 4-hour nor 6-hour TRF affected insomnia severity or the risk of obstructive sleep apnea, indicating that while TRF can aid in weight loss, it may not enhance sleep-related outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Cienfuegos, S., Gabel, K., Kalam, F., et al.[2022]

In an 8-week study of time-restricted feeding (TRF) involving 32 women (13 premenopausal and 19 postmenopausal), both groups experienced similar weight loss of about 3.3% without any significant differences between them.

Both premenopausal and postmenopausal women showed reductions in fat mass, lean mass, fasting insulin, and oxidative stress markers, indicating that TRF can provide metabolic benefits regardless of menopausal status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in body weight and metabolic risk during time restricted feeding in premenopausal versus postmenopausal women. Cienfuegos, S., Gabel, K., Kalam, F., et al.[2023]

In a study involving 15 men over 8 weeks, time-restricted eating (TRE) significantly altered 24-hour profiles of key metabolic markers, including insulin and triglycerides, suggesting potential benefits for metabolic health.

TRE also influenced the expression of genes related to circadian rhythms and transcriptional regulation in subcutaneous adipose tissue, indicating a mechanism by which TRE may improve metabolic function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-restricted eating alters the 24-hour profile of adipose tissue transcriptome in men with obesity. Zhao, L., Hutchison, AT., Liu, B., et al.[2023]

In a study involving adults with obesity, both 4-hour and 6-hour time-restricted feeding (TRF) regimens led to comparable weight loss of about 3% over 8 weeks, along with improvements in insulin resistance and oxidative stress.

Participants in the TRF groups reduced their daily energy intake by approximately 550 kcal without needing to count calories, suggesting that TRF can be an effective and manageable approach for weight loss and improving cardiometabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of 4- and 6-h Time-Restricted Feeding on Weight and Cardiometabolic Health: A Randomized Controlled Trial in Adults with Obesity. Cienfuegos, S., Gabel, K., Kalam, F., et al.[2022]

Time-restricted eating, particularly when meals are consumed earlier in the day, can lead to decreased energy intake and body weight over extended periods (4-16 weeks) without negatively impacting sleep quality.

While time-restricted eating affects the timing of energy metabolism, it does not change total energy expenditure over 24 hours, suggesting a potential mechanism for weight management through dietary timing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meal Timing and Sleeping Energy Metabolism. Yoshitake, R., Park, I., Ogata, H., et al.[2023]

In a 12-week study involving 23 obese adults, time-restricted feeding (TRF) with an 8-hour eating window was found to be safe, as there were no significant changes in self-reported adverse events or disordered eating patterns.

The study suggests that TRF can effectively support weight loss in obese individuals without negatively impacting their health or body image perception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of 8-h time restricted feeding in adults with obesity. Gabel, K., Hoddy, KK., Varady, KA.[2019]

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