Obesity Clinical Trial
Official title:
Effect of Long Term Sleep Restriction on Energy Balance
Verified date | March 2024 |
Source | Columbia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The overall goal of this project is to look at the effects of long-term, sustained sleep restriction (SR) in adults, and assess the effects on mood and cognitive and physical performance.
Status | Completed |
Enrollment | 45 |
Est. completion date | December 14, 2022 |
Est. primary completion date | December 14, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 75 Years |
Eligibility | Inclusion Criteria: - BMI 25-29.9 kg/m2 - Have at least one obese parent - Habitually sleep 7-9 hours a night - Free of any current and past sleep and psychiatric disorders, including eating disorders, diabetes or Cardiovascular disease (CVD) (i.e., normal scores on: Pittsburgh Quality of Sleep Questionnaire Epworth Sleepiness Scale, Berlin Questionnaire, Sleep Disorders Inventory Questionnaire, Beck Depression Inventory, Composite Scale of Morningness/Eveningness, Three Factor Eating Questionnaire) - All racial/ethnic groups Exclusion Criteria: - Smokers (any cigarettes or ex-smoker < 3 years) - Neurological, medical or psychiatric disorder - Diabetics - Eating and/or sleep disorders - Contraindications for MRI scanning - Travel across time zones within 4 weeks - History of drug and alcohol abuse - Shift worker (or rotating shift worker) - Caffeine intake > 300 mg/d - Heavy equipment operators - Commercial long-distance drivers |
Country | Name | City | State |
---|---|---|---|
United States | New York Nutrition Obesity Research Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University | National Heart, Lung, and Blood Institute (NHLBI), NYU Langone Health |
United States,
Barragan R, Zuraikat FM, Cheng B, Scaccia SE, Cochran J, Aggarwal B, Jelic S, St-Onge MP. Paradoxical Effects of Prolonged Insufficient Sleep on Lipid Profile: A Pooled Analysis of 2 Randomized Trials. J Am Heart Assoc. 2023 Oct 17;12(20):e032078. doi: 10 — View Citation
Barragan R, Zuraikat FM, Tam V, RoyChoudhury A, St-Onge MP. Changes in eating patterns in response to chronic insufficient sleep and their associations with diet quality: a randomized trial. J Clin Sleep Med. 2023 Nov 1;19(11):1867-1875. doi: 10.5664/jcsm — View Citation
Barragan R, Zuraikat FM, Tam V, Scaccia S, Cochran J, Li S, Cheng B, St-Onge MP. Actigraphy-Derived Sleep Is Associated with Eating Behavior Characteristics. Nutrients. 2021 Mar 5;13(3):852. doi: 10.3390/nu13030852. — View Citation
Benasi G, Cheng B, Aggarwal B, St-Onge MP. The effects of sustained mild sleep restriction on stress and distress among healthy adults: Findings from two randomized crossover studies. Sleep Med. 2024 Mar;115:83-87. doi: 10.1016/j.sleep.2024.02.001. Epub 2 — View Citation
Keith SW, Redden DT, Katzmarzyk PT, Boggiano MM, Hanlon EC, Benca RM, Ruden D, Pietrobelli A, Barger JL, Fontaine KR, Wang C, Aronne LJ, Wright SM, Baskin M, Dhurandhar NV, Lijoi MC, Grilo CM, DeLuca M, Westfall AO, Allison DB. Putative contributors to the secular increase in obesity: exploring the roads less traveled. Int J Obes (Lond). 2006 Nov;30(11):1585-94. doi: 10.1038/sj.ijo.0803326. Epub 2006 Jun 27. — View Citation
Li XY, Yoncheva Y, Yan CG, Castellanos FX, St-Onge MP. Chronic Mild Sleep Restriction Does Not Lead to Marked Neuronal Alterations Compared With Maintained Adequate Sleep in Adults. J Nutr. 2024 Feb;154(2):446-454. doi: 10.1016/j.tjnut.2023.12.016. Epub 2 — View Citation
Luckhaupt SE, Tak S, Calvert GM. The prevalence of short sleep duration by industry and occupation in the National Health Interview Survey. Sleep. 2010 Feb;33(2):149-59. doi: 10.1093/sleep/33.2.149. — View Citation
Makarem N, Zuraikat FM, Aggarwal B, Jelic S, St-Onge MP. Variability in Sleep Patterns: an Emerging Risk Factor for Hypertension. Curr Hypertens Rep. 2020 Feb 21;22(2):19. doi: 10.1007/s11906-020-1025-9. — View Citation
McAlpine CS, Kiss MG, Zuraikat FM, Cheek D, Schiroli G, Amatullah H, Huynh P, Bhatti MZ, Wong LP, Yates AG, Poller WC, Mindur JE, Chan CT, Janssen H, Downey J, Singh S, Sadreyev RI, Nahrendorf M, Jeffrey KL, Scadden DT, Naxerova K, St-Onge MP, Swirski FK. — View Citation
Smith I, Salazar I, RoyChoudhury A, St-Onge MP. Sleep restriction and testosterone concentrations in young healthy males: randomized controlled studies of acute and chronic short sleep. Sleep Health. 2019 Dec;5(6):580-586. doi: 10.1016/j.sleh.2019.07.003. — View Citation
St-Onge MP, Campbell A, Salazar I, Pizinger T, Liao M, Aggarwal B. Information on Bedtimes and Wake Times Improves the Relation Between Self-Reported and Objective Assessments of Sleep in Adults. J Clin Sleep Med. 2019 Jul 15;15(7):1031-1036. doi: 10.5664 — View Citation
Zimmerman ME, Benasi G, Hale C, Yeung LK, Cochran J, Brickman AM, St-Onge MP. The effects of insufficient sleep and adequate sleep on cognitive function in healthy adults. Sleep Health. 2024 Jan 16:S2352-7218(23)00293-0. doi: 10.1016/j.sleh.2023.11.011. O — View Citation
Zuraikat FM, Makarem N, Redline S, Aggarwal B, Jelic S, St-Onge MP. Sleep Regularity and Cardiometabolic Heath: Is Variability in Sleep Patterns a Risk Factor for Excess Adiposity and Glycemic Dysregulation? Curr Diab Rep. 2020 Jul 23;20(8):38. doi: 10.1007/s11892-020-01324-w. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | NIH Toolbox® for Assessment of Neurological and Behavioral Function (NIH Toolbox) | Measure cognitive, emotional, sensory, and motor functions, raw scores | Baseline, Week 6 (endpoint) | |
Other | Neuro-behavioral measures | ModRey memory task | Baseline, Week 6 (endpoint) | |
Other | Immune function | T-cell stimulation | Baseline, Week 6 (endpoint) | |
Other | Immune markers | White blood cell populations | Baseline, Week 6 (endpoint) | |
Other | Activity | 6-minute walk test | Week 5 | |
Primary | Change in Fat Mass | Body composition (specifically fat mass) will be measured by MRI at baseline and endpoint. | Baseline, Week 6 (endpoint) | |
Secondary | Energy Expenditure (EE) | EE is the amount of energy (or calories) that a person needs to carry out physical functions and will be assessed using Doubly Labeled Water (DLW), during the last 2 weeks of each sleep phase. | Weeks 5 and 6 (endpoint) | |
Secondary | Physical activity | Time spent in sedentary, light, moderate, and moderate-to-vigoroud physical activity. | 6 weeks (measured daily) | |
Secondary | Appetite-regulating hormones | Ghrelin, leptin, glucagon-like peptide 1, orexin, NPY | Baseline, Week 6 (endpoint) | |
Secondary | Neuronal activity | Neuronal activity at rest and in response to food stimuli | Week 6 |
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