Effect of Sleep Restriction on Metabolic Disturbances Caused by Overfeeding

NCT02075723 | Unknown DMC

• 1 other identifier: SleepDep 02/14
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if sleep restriction provokes an increase in risk factors for metabolic diseases, such as elevation of ectopic fat and decreased sensitivity to insulin. We propose to evaluate the effect of sleep restriction in a model of metabolic challenge (overfeeding) caricaturing the conditions of modern societies everyday life .

Conditions

Sleep

Outcome Measures

Primary Outcomes (1)

• Accumulation of fat in the liver (measured by nuclear magnetic resonance ) and the tissue insulin sensitivity ( measured by a test meal ) in response to a sleep restriction in overfeeding condition .

  After 6 days of sleep restriction (4 h/day) vs. normal sleep (8 h/day)

Secondary Outcomes (1)

• Blood concentrations of circulating fatty acids and glycerol

  After 6 days of sleep restriction (4 h/day) vs. normal sleep (8 h/day)

Study Arms (2)

Overfeeding + sleep restriction

EXPERIMENTAL

overfeeding condition (130 % of energy requirements ) + 6 days of sleep restriction (4 hours per night)

Dietary Supplement: Overfeeding (130 % of energy requirements ); Behavioral: Sleep restriction (4 hours per night)

Overfeeding + normal sleep duration

EXPERIMENTAL

overfeeding condition (130 % of energy requirements ) + 6 days of normal sleep duration (8 hours per night)

Dietary Supplement: Overfeeding (130 % of energy requirements )

Interventions

Overfeeding (130 % of energy requirements ) DIETARY_SUPPLEMENT

Overfeeding (130 % of energy requirements )

Overfeeding + normal sleep duration; Overfeeding + sleep restriction

Sleep restriction (4 hours per night) BEHAVIORAL

Sleep restriction (4 hours per night)

Overfeeding + sleep restriction

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Good general health
• BMI 18.5-25 kg/m2
• Blood pressure at rest less than 140/ 90 mmHg .
• Physical activity level: sedentary or light (\< 3 hours of sport per week )
• Lack of sleep pathology ( including sleep apnea and insomnia )
• Regular sleep-wake cycles
• Average duration of sleep over 7h
• Circadian Typology by Horne \& Ostberg questionnaire ≥ 30 and ≤ 70
• Score questionnaire Pittsburgh Sleep Quality Index ≤ 5
• Screening polysomnography showing sleep efficiency ≥ 85 % and apnea- hypopnea index and periodic leg movements \< 15 / h .

You may not qualify if:

• Current smoking
• Family history of diabetes
• History of sleep disorders
• Circadian Typology by Horne \& Ostberg \[ 16-30 \] or \[ 70-86 \]
• Score questionnaire Pittsburgh Sleep Quality Inde x\> 5
• Polysomnography indicating a sleep efficiency \<85% and apnea-hypopnea index and periodic leg movements \> 15 / h.
• Consumption of more than 3 coffees a day
• Drinking alcool (more than 10g /d)
• Use of Drugs
• Medication
• Night work by shifts
• Average duration of sleep less than 7 hours per night
• Occupational Risks in sleep restriction conditions: e.g. professional drivers
• Special Diet ( vegetarianism, veganism , etc. )
• Change in weight of more than 3 kg in the last 3 months

Sponsors & Collaborators

• University of Lausanne Hospitals: lead

Study Sites (1)

Center for Investigation and Reseaarch on Sleep and Physiology Department, University Hospital

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

Related Publications (1)

• Cros J, Pianezzi E, Rosset R, Egli L, Schneiter P, Cornette F, Pouymayou B, Heinzer R, Tappy L, Kreis R, Boesch C, Haba-Rubio J, Lecoultre V. Impact of sleep restriction on metabolic outcomes induced by overfeeding: a randomized controlled trial in healthy individuals. Am J Clin Nutr. 2019 Jan 1;109(1):17-28. doi: 10.1093/ajcn/nqy215.

  PMID: 30615104 DERIVED

Related Links

• Center for Investigation and Research on Sleep, University Hospital, Lausanne, Switzerland

Study Officials

• José Haba-Rubio, MD

  Center for Investigation and Research on Sleep, University Hospital, Lausanne, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 27, 2014
• First Posted: March 3, 2014
• Study Start: February 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 27, 2015

Record last verified: 2015-05

Locations

CH (1)