Sleep Restriction for Metabolic Health

(SAM Trial)

Overseen By Andrew McHill, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Must not be taking: Antidepressants, Neuroleptics, Tranquilizers

Disqualifiers: Psychiatric disorders, Hypertension, Diabetes, Respiratory diseases, others

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

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how sleep patterns and body clocks affect metabolism, focusing on their influence on blood sugar levels and energy use. Participants will undergo periods of reduced sleep (chronic sleep restriction) to observe these effects. Individuals without sleep disorders, recent time zone travel, or major health conditions are well-suited for this study. As an unphased study, this trial offers a unique opportunity to advance scientific understanding of sleep and metabolism.

Will I have to stop taking my current medications?

Yes, participants must stop taking any prescribed or over-the-counter medications, except for birth control, to be eligible for this study.

What prior data suggests that this protocol is safe?

Research shows that insufficient sleep over time can affect both mind and body. Studies have found that people who lack sleep may struggle with clear thinking and often feel tired during the day. Insufficient sleep can also lead to health issues like weight gain and difficulty managing sugar levels, increasing the risk of diabetes.

One study discovered that even without prolonged wakefulness, missing sleep can still impair concentration. However, these effects can vary among individuals, so experiences may differ.

This study will examine the effects of sleep loss in a controlled setting, with health professionals closely monitoring participants throughout. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Sleep Restriction for Metabolic Health trial because it's exploring how our sleep patterns might directly influence metabolic health, which is a novel angle compared to traditional approaches like diet and exercise. Unlike most treatments that focus on medication or lifestyle changes, this trial involves adjusting sleep duration to see if it can improve metabolic outcomes. By examining the impacts of chronic sleep restriction and comparing it to normal sleep, researchers hope to uncover new insights on how sleep quantity affects metabolism and potentially identify sleep adjustment as a new way to tackle metabolic issues.

What evidence suggests that chronic sleep restriction is effective for metabolic health?

Research has shown that insufficient sleep can harm the body's ability to manage weight and sugar levels. Studies have found that sleeping less can lead to weight gain and increase the risk of health problems like obesity and diabetes. This trial will compare two conditions: one where participants experience sleep restriction, obtaining 5.5 hours of sleep per 24 hours, and another controlled condition where participants obtain 8 hours of sleep per 24 hours. Lack of sleep can increase hunger, provide more time to eat, and reduce energy expenditure. Additionally, consistently getting too little sleep is linked to difficulties in processing sugar and heart problems. These findings suggest that adequate sleep is important for maintaining a healthy body. ^{3 6 7 8 9}

Who Is on the Research Team?

Andrew McHill, PhD

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

This trial is for drug-free adults aged 18-40 with no chronic diseases, a BMI between 18.5 and 25 kg/m2, waist circumference <94/80cm, non-smokers or minimal smoking history. Excludes those with immune, cardiovascular, respiratory disorders; metabolic syndrome; diabetes; sleep disorders; psychiatric conditions; current medication (except birth control); recent shift work or travel across time zones.

Inclusion Criteria

I am not currently taking any medications.

My cancer is currently in remission.

Exclusion Criteria

I have a lung or breathing condition.

I have high blood pressure and am taking beta blockers.

You have any severe sleep problems or unusual sleep patterns.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Ambulatory Monitoring

Participants maintain a consistent 7-day at home 8h sleep schedule at habitual times before laboratory visits, verified by actigraphy, sleep logs, and call-ins.

7 days

Daily check-ins (virtual)

Outpatient Diet

Participants consume an isocaloric diet for 3 days prior to each protocol, designed to meet individual daily energy requirements.

3 days

Daily check-ins (virtual)

Inpatient Protocols

Participants undergo a 14-day inpatient protocol with sleep/wake schedule manipulation and ad libitum food access, including sleep restriction and control conditions.

14 days

Continuous monitoring (inpatient)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Chronic Sleep Restriction

Trial Overview

The study investigates how lack of sleep and circadian rhythm affect metabolism and glucose tolerance over a period of three weeks. Participants will undergo periods of sleep restriction in a controlled environment to determine the impact on their energy metabolism.

How Is the Trial Designed?

Group I: Sleep Restriction First Experimental Treatment 1 Intervention

Equivalent to obtaining 5.5.h of sleep per 24h; n=10. Participants live on a 20h-day and will experience 15.33h wake episodes followed by sleep episodes of 4.67h long. Ad libitum food is provided during this time and participants will be fed \~130-150% of their daily caloric needs across three meals a day.

Group II: Controlled Condition First Active Control 1 Intervention

Equivalent to obtaining 8h sleep per 24h; n=10. Participants live on a 20h-day and will experience 13.33h wake episodes followed by 6.67h sleep opportunities. Ad libitum food is provided during this time and participants will be fed \~130-150% of their daily caloric needs across three meals a day.

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

Published Research Related to This Trial

Prolonged sleep restriction combined with circadian disruption, as experienced by shift workers, negatively impacts glucose regulation and metabolism, leading to increased plasma glucose levels after meals.

After a recovery period of 9 days with adequate sleep and circadian re-entrainment, metabolic parameters returned to normal, suggesting that proper sleep and circadian alignment are crucial for maintaining healthy metabolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse metabolic consequences in humans of prolonged sleep restriction combined with circadian disruption. Buxton, OM., Cain, SW., O'Connor, SP., et al.[2022]

Reduced sleep duration and quality are linked to hormonal imbalances that can increase the risk of obesity and type 2 diabetes, as sleep loss affects hormones like leptin and ghrelin that regulate appetite and energy expenditure.

The decline in average sleep duration over the past 50 years correlates with rising obesity rates, suggesting that improving sleep could be a crucial public health strategy to combat metabolic syndrome and related health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic consequences of sleep and sleep loss. Van Cauter, E., Spiegel, K., Tasali, E., et al.[2022]

Chronic partial sleep loss is linked to an increased risk of obesity and diabetes, as it negatively affects glucose regulation and insulin sensitivity, leading to a higher likelihood of developing diabetes.

Sleep deprivation disrupts appetite regulation by decreasing leptin (which signals fullness) and increasing ghrelin (which promotes hunger), potentially causing individuals to misinterpret their energy needs and leading to overeating.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations between sleep loss and increased risk of obesity and diabetes. Knutson, KL., Van Cauter, E.[2022]

Partial sleep deprivation, defined as sleeping less than 6 hours per night, is linked to weight gain due to its negative impact on appetite-regulating hormones, increasing ghrelin and decreasing leptin, which can lead to higher energy intake.

While energy expenditure may not significantly change with partial sleep deprivation, it can lead to undesirable body composition changes, resulting in a greater loss of fat-free mass compared to fat mass, highlighting the importance of sufficient sleep for effective weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Partial sleep deprivation and energy balance in adults: an emerging issue for consideration by dietetics practitioners. Shlisky, JD., Hartman, TJ., Kris-Etherton, PM., et al.[2022]

Chronic sleep restriction, defined as sleeping less than 6 hours a night, is linked to increased risks of obesity and metabolic health issues, highlighting its significance for endocrinologists.

Sleep loss triggers metabolic adaptations that can lead to increased food intake and energy conservation, potentially undermining weight loss efforts through diet and exercise in overweight individuals, suggesting the importance of adequate sleep in weight management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on energy homeostasis and insufficient sleep. Penev, PD.[2021]

Reduced sleep duration is linked to metabolic and hormonal changes that can lead to obesity, including decreased insulin sensitivity and increased hunger hormones like ghrelin.

The review emphasizes the importance of adequate sleep for maintaining metabolic health, suggesting that sleep curtailment may contribute to the rising rates of obesity, although further research and intervention studies are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short sleep duration and obesity: mechanisms and future perspectives. Zimberg, IZ., Dâmaso, A., Del Re, M., et al.[2012]

Epidemiological studies indicate that shorter sleep duration is linked to increased risks of metabolic disorders like obesity, diabetes, and hypertension, suggesting a mechanistic relationship between sleep and metabolism.

Sleep deprivation negatively affects hormones related to appetite and insulin sensitivity, which can lead to insulin resistance and hypertension, highlighting the importance of improving sleep quality and duration as potential preventive measures for these metabolic issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidemiological evidence for the links between sleep, circadian rhythms and metabolism. Gangwisch, JE.[2022]

Sleep restriction for 5 nights significantly impairs insulin sensitivity and the dynamic response of nonesterified fatty acids (NEFAs) during glucose metabolism, indicating a negative impact on metabolic health.

Two nights of recovery sleep were insufficient to fully restore insulin sensitivity and glycemic health, suggesting that chronic sleep deprivation has lasting effects on metabolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two nights of recovery sleep restores the dynamic lipemic response, but not the reduction of insulin sensitivity, induced by five nights of sleep restriction. Ness, KM., Strayer, SM., Nahmod, NG., et al.[2020]

In a study of 1486 participants aged 53 to 93, those who slept 6 hours or less had more than double the odds of developing diabetes compared to those sleeping 7 to 8 hours, indicating that insufficient sleep is a significant risk factor for diabetes.

Interestingly, even those sleeping 9 hours or more also showed increased odds for diabetes and impaired glucose tolerance, suggesting that both too little and too much sleep can negatively impact metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of sleep time with diabetes mellitus and impaired glucose tolerance. Gottlieb, DJ., Punjabi, NM., Newman, AB., et al.[2022]

In a study of overweight or obese adults, those who underwent caloric restriction (CR) alone lost a greater proportion of fat mass compared to those who combined caloric restriction with moderate sleep restriction (CR + SR), despite both groups losing similar amounts of total weight.

Moderate sleep restriction (about 1 hour less sleep on five nights) negatively impacted body composition, leading to less fat loss during a hypocaloric diet, suggesting that sleep quality may play a crucial role in effective weight loss strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of sleep restriction on weight loss outcomes associated with caloric restriction. Wang, X., Sparks, JR., Bowyer, KP., et al.[2023]

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