Effects of Impaired Sleep on Energy Balance

Obesity Clinical Trial

— SLOPUS  

Official title:

Effects of Impaired Sleep on Energy Balance: A Randomized, 2-Condition, Crossover Study in Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01198431
• Other study ID #: OPUS-B261
• Status: Completed
• Phase: N/A
• First received: September 8, 2010
• Last updated: August 9, 2011
• Start date: October 2009
• Est. completion date: February 2011

Study information

• Verified date: September 2010
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main aim of this study is to examine the effects of restricted sleep on energy and substrate metabolism as well as relevant hormonal systems that might be involved in the underlying mechanisms.

The investigators hypothesize that short-term sleep curtailment in adolescents is accompanied by 1) increased hunger and desire to eat; 2) increased spontaneous energy intake; 3) reduced spontaneous physical activity; and 4) increased fluctuation in hormones in a way that could favour a positive energy balance and potentially weight gain on the long run.

Description:

The background for this project is that despite considerable knowledge of the mechanisms regulating body weight, the prevalence of obesity has not declined. The individual and environmental factors that play a part in energy balance are still not completely understood, and current methods for loosing and maintaining body weight are generally unsuccessful. Knowledge about what brings about changes in metabolism and lifestyle is lacking.

Reduced sleep duration has been observed in parallel with increases in body weight. Lack of sleep has become a hallmark of modern man, and both children and adults sleep less today than just a few decades ago. Research suggests that both too much and too little sleep can lead to obesity, but correlations between sleep deprivation and other lifestyle-related ailments have also been observed. The reasons for these correlations are far from clear, especially in children and adolescents.

The main purpose of SLOPUS is to investigate the effects of reduced sleep on energy and substrate metabolism, and the relevant hormonal systems involved in the underlying mechanisms. Our hypothesis is that acute sleep deprivation in teenagers leads to increased hunger and desire to eat, increased spontaneous energy intake, decreased spontaneous physical activity, and increased fluctuation in the hormones that control energy metabolism.

The investigators aim to recruit twenty-four healthy, normal weight boys aged 15-19 years with normal sleep pat-terns. The study will be conducted as a randomized, crossover study with two conditions. Each participant will be subjected to short sleep (4 hours) and normal sleep (9 hours), in random order, for three consecutive nights in a respiration chamber. They will stay in the chamber for the 24 hours before the last night. In the respiration chamber energy turnover is measured - both how much energy and also the type of substrate combusted. The chamber is equipped with a bed, toilet, television, computer, and communication. Food and drink can be supplied via an airlock. Measurements in the chamber include volitional activities and sleep duration/quality.

Energy turnover will be measured using a ventilated hood system on the first and last day. Here the participants lie down on a bed with their heads under a transparent canopy for 25-minute intervals during the morning. Blood samples will also be taken during these periods. Meal tests will be served, where we measure the amount of food ingested, and subjects will be given questionnaires about hunger and satiety to fill out. Physical activity and heart rate will be measured throughout the trial.

Thus, the present study is likely to result in a number of new and important findings regarding the impact of impaired sleep on energy balance and it might improve the recommendations for optimal sleep in adolescents.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 15 Years to 19 Years

Eligibility

Inclusion Criteria:

• normal weight (5th percentile to less than the 85th percentile)

Exclusion Criteria:

• self-reported sleep problems (Pittsburgh Sleep Quality Index score >5);

• night work;

• variable sleep habits or habitual daytime naps;

• regular physical exercise (>3 hours/week);

• excessive intake of alcohol (>7 drinks/week);

• excessive intake of caffeine (>300 mg/day);

• smoking;

• substance abuse;

• use of prescription medications or over-the-counter drugs affecting sleep or metabolism;

• chronic diseases (e.g. cancer, asthma, back pain, thyroid disease, heart disease, diabetes, etc.)

• history of neurological, medical or sleep disorders;

• trans-meridian travelling the last month;

• eating disorder;

• irregular eating schedule (e.g. skipping breakfast);

• unable to comply with the protocol.

Related Conditions & MeSH terms

• Obesity
• Sleep

Intervention

Behavioral:
• Sleep duration
Duration of sleep per night

Locations

Country	Name	City	State
Denmark	Department of Human Nutrition, Faculty of LIFE Sciences, University of Copenhagen	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Energy expenditure	Energy expenditure and substrate oxidation rate will be assessed by 24-hour indirect whole-body calorimetry (respiration chamber) on the basis of measurements of oxygen consumption, carbon dioxide production, and nitrogen excretion in urine.	Over the course of 24 hours on day 3
Secondary	Spontaneous energy intake	In an attempt to measure spontaneous energy intake in an experimental context, the participant will be given an ad libitum lunch at noon. The ad libitum meal is a homogenous meal with a macronutrient composition of: 15 E%; fat: 30 E%; carbohydrate: 55 E%.The portion of pasta is larger than the expected participant's intake. The meal will be weighted before and after the lunch and ad libitum energy intake is assessed from the amount of the meal consumed by a food technician.	Measured after a maximum of 30 minutes meal time on day 1 and day 4
Secondary	Spontaneous physical activity	Spontaneous physical activity is measured by a wrist worn actigrpahy device during the three days of intervention. Moreover, spontaneous activity in the respiration chamber will be assessed by in-biuld microwave radar detectors	24 hours for 3 consecutive days
Secondary	Appetite regulating hormones and stress hormones	Hormones are sampled from blood, saliva, and urine.	Measured every half hour over the course of 4 hours on day 1 and day 4
Secondary	Hunger and desire to eat	Hunger and desire to eat is measured using visual analogue scales before and after a standardized breakfast meal challange and before and after an ad libitum meal.	Measured every hour or half hour over the course of 9 hours on day 1 and day 4
Secondary	Stress hormone (cortisol)	Hormones are sampled saliva.	Measured at 7 am and 7.30 am on day 1 and day 4