Understanding how sleep affects metabolism and weight gain
Official title: Uncovering Sleep and Circadian Mechanisms Contributing to Adverse Metabolic Health
Run by Oregon Health and Science University · NCT05775627 · Data updated 2026-11-12
This study is testing how not getting enough sleep and the timing of sleep can affect metabolism and weight gain in people.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 40 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 1 site (Portland, Oregon) |
| Status | Recruiting |
| Started | December 1, 2023 |
| Main results expected | June 30, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | April 3, 2024 |
| Trial ID | NCT05775627 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are healthy adults aged 18 to 40 with a normal body mass index and no dietary restrictions.
✕Probably not a fit
Patients with significant dietary restrictions or those outside the specified age and BMI range may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to explore the mechanisms by which sleep deprivation and circadian timing influence metabolic health, particularly focusing on energy metabolism and glucose tolerance. Participants will undergo a 21-day randomized-crossover protocol, which includes 7 days of outpatient monitoring followed by 14 days of inpatient observation. The study will assess the effects of chronic sleep restriction and circadian timing on energy intake patterns and food choices. By analyzing these factors, the research seeks to clarify the relationship between sleep duration and metabolic disorders such as obesity and diabetes.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for managing obesity and diabetes through better sleep management.
How similar studies have gone: Previous studies have indicated a link between sleep deprivation and metabolic health, suggesting that this approach may yield valuable insights.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Between 18 and 40 years of age
* Drug free
* Established disease-free status
Exclusion Criteria:
1. Dietary restrictions
Participants must not have dietary restrictions that could systematically bias their macronutrient intake. The following will exclude participants from enrolling in the study based on their diet:
* Participants who choose not to or cannot consume dairy products (milk, yogurt, cheese, ice cream)
2. Body Composition
A body mass index (BMI) of 18.5\< \[BMI\] \< 25 kg/m2 and a waist circumference \<94/80cm.
3. Psychiatric/psychological suitability
Each participant will undergo a structured interview (Mini International Neuropsychiatric Interview) with a qualified OHSU physician. This physician will supervise the administration and scoring of a Beck Depression Inventory II (BDI-II) questionnaire for each potential participant. The following will exclude individuals from participating based on their psychiatric or psychological evaluation:
* Individuals with evidence of psychopathology on the BDI-II, or in a structured clinical interview with the physician
* A history of severe psychiatric illnesses
* Alcoholism
* Drug dependency
* Major depression
* Manic depressive illness
* Schizophrenic disorders
* Panic disorder
* Generalized anxiety disorder
* Post-traumatic stress disorder
* Agoraphobia
* Claustrophobia
* Paranoid personality disorder
* Schizoid personality disorder
* Schizotypal personality disorder
* Borderline personality disorder
* Antisocial personality disorder.
* History of using antidepressant medication
* History of using neuroleptic medication
* History of using tranquilizers
4. Drug/alcohol use
Volunteers must be drug-free (including caffeine, nicotine, alcohol and herbal medications) for the entire duration of the outpatient and in-laboratory study period, with no history of drug or alcohol dependency. All participants must be:
* Current non-smokers, and are required to have a history of less than 5 'pack years' of smoking
5. Medication/drug use
Volunteers must not be taking any prescribed medications or over the counter medications, with an exception for birth control.
6. Prior shift work
For stability of endogenous circadian rhythmicity, volunteers must have no history of the following 1 year prior to the study:
* Working irregular day and night hours
* Regular night work
* Rotating shift work f
* Not have traveled more than 1 time zone during 3 months prior to the study
7. Chronobiologic and sleep disorders
* Hypernychthemeral sleep/wake cycle
* Delayed sleep phase syndrome (wake time \> 2 hours later than desired or habitually after 10:00 AM)
* Advanced sleep phase syndrome (wake time \> 2 h earlier than desired or habitually before 5:00 AM)
* Narcolepsy
* Sleep apnea (apnea index \>15)
* Insomnia (sleep complaint by history or polygraphically recorded sleep efficiency \< 80%)
* Hypersomnia
* Periodic Limb Movement (PLMS) (PLMS index \>15)
* Nocturnal Paroxysmal Dystonia
* REM-sleep behavior disorder
* Nocturnal Enuresis; (self-report and first night in the laboratory)
* Obstructive sleep apnea (apnea/hypopnea index \>5/h as determined by at-home monitoring)
* The investigators will also exclude individuals with extreme chronotype using the Horne-Ostberg Morningness/Eveningness questionnaire (i.e., the Owl/Lark Questionnaire)
8. Diseases of the Cardiovascular System
* Hypertension (systolic blood pressure \> 140 or diastolic blood pressure \> 90)
* Heart failure
* Cardiomyopathy
* Cor pulmonale
* Ischemic heart disease
* Valvular heart disease
* History of heart transplantation
* Cardiac tumors
* Pericardial disease
9. Metabolic Syndrome
Following American Heart Association cutoffs, participants who have, in addition to abdominal fat (obese exclusion criteria), two or more of these factors will be excluded from the study:
* HDL cholesterol of less than 40 mg/dL in men or less than 50 mg/dL in women
* Systolic blood pressure \>135 mmHg or diastolic blood pressure \>85 mmHg
* Fasting blood glucose ≥ 100 mg/dL
* Triglycerides ≥ 150 mg/dL
10. Pre-Diabetes/Diabetes
For participants who have a fasting blood glucose level of ≥ 100 mg/dL the investigators will measure hemoglobin A1c to exclude for diabetes (HbA1c\>5.7%).
11. Hypertension
An upper cut off of 140/90 mmHg during an office blood pressure measure will be used as an exclusion criterion. After 5 minutes of rest in a seated position, blood pressure will be measured 3 times, taken 1 minute apart. The average will be used to confirm eligibility criteria. Current or history of beta blocker use will also be exclusionary.
12. Disorders of the Respiratory System
* Asthma
* Cystic fibroses
* Chronic bronchitis
* Emphysema
* Airway obstruction
* Interstitial lung diseases
* Pulmonary hypertension
* Lung neoplasms
* ARDS
13. Disorders of the Kidney and Urinary Tract
* Acute or chronic renal failure
* History of renal transplantation
* Tubulointerstitial diseases of the kidney
* Urinary tract obstruction
* Tumors of the urinary tract
14. Infectious Diseases
* Infective endocarditis
* HIV infection
* Sexually transmitted diseases \[e.g., syphilis (including congenital syphilis and its sequelae), gonorrhea\],
* Urinary tract infection
* Osteomyelitis
* Brucellosis
* Toxoplasmosis,
* Tuberculosis
* Leptospirosis
* Lyme disease
* Mononucleosis
* Hepatitis
* Parasitic infections such as malaria, toxoplasmosis, giardiasis, schistosomiasis, leishmaniasis
15. Disorders of the Gastrointestinal System
* Esophagitis
* Peptic ulcer and gastritis
* Neoplasms of the esophagus, stomach or bowel
* Disorders of absorption
* Inflammatory bowel disease
* Diseases of the small and large intestine
* Acute appendicitis
* Cirrhosis or neoplasms of the liver
* History of liver transplantation
* Diseases of the gallbladder and bile ducts
* Pancreatic disease
16. Disorders of the Immune System, Connective Tissue and Joints
* AIDS
* Systemic lupus erythematosus
* Rheumatoid arthritis
* Scleroderma
* Ankylosing spondylitis
* Vasculitis
* Sarcoidosis
17. Disorders of the Hematopoietic System
* Anemia
* Leukemia
* Myeloproliferative diseases
* History of bone marrow transplantation
18. Neoplastic Diseases
* Lymphoma
* Carcinoma
* Melanoma
* Any other neoplastic diseases
19. Endocrine and Metabolic Diseases
* Thyroid disease
* Addison's Disease
* Cushing's Syndrome
* Aldosteronism
* Hypoaldosteronism
* Pheochromocytoma
* Disorders of sexual differentiation that require hormone supplementation that may alter body weight
* Disorders of neuroendocrine regulation
* Diseases of the anterior pituitary and hypothalamus
* Hemochromatosis porphyria
* Wilson's Disease
* Glycogen storage diseases
* Diseases of the parathyroid gland
* Metabolic bone disease
* Disorders of phosphorus or magnesium metabolism
* Paget's Disease
20. Neurologic Disorders
* Epilepsy and disorders of consciousness
* Dementia
* Amnesic disorders
* Neoplastic diseases of the central nervous system
* Demyelinating diseases
* Parkinson's Disease
* Muscular dystrophy
* Myasthenia gravis
* Periodic paralysis
* Dermatomyositis
* Polymyositis
* Infections of the nervous system
* Stroke
* History of transient ischemic attacks
* Hydrocephalus
* Tumors of the pituitary gland
* Pinealoma
* Intervertebral disc disease
* Ataxia
* Gilles de la Tourette Syndrome
* Huntington's Disease
* Tardive dyskinesia
* History of recurrent migraine headaches
* Neuromuscular disease.
21. Subjects must not be currently participating in another research study that would influence their safe participation in our study. Subjects must not be participating in a research study in which they do the following:
* Ingest experimental medication
* Give blood samples
Where it's running
-
Oregon Health & Science University
Portland, Oregon, United States Recruiting
Study contacts
- Principal investigator: Andrew McHill, PhD — Oregon Health and Science University
- Study coordinator: Andrew McHill, PhD
- Email: mchill@ohsu.edu
- Phone: 503-494-2594
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.