Energy Expenditure, Sleep and Macronutrients

Not Applicable

• Conditions: Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms
• Interventions: Dietary Supplement: Differences in protein content of meals

• Registration Number: NCT01551238
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

The purpose of this study is to determine energy expenditure and sleep in response to protein/carbohydrate and fat ratio of the diet over a short-term and long-term period of time.

Detailed Description

The prevalence of obesity has increased worldwide to epidemic proportions. For long-term treatment success permanent lifestyle changes are necessary with regard to approach to food, physical activity patterns and behavior to emotional stress. Moreover, an association has been shown between sleep disturbance and obesity. Weight loss strategies regarding food intake regulation mainly focused on changing patterns of fat and carbohydrate consumption during the last decades. The role of protein has largely been ignored. However, protein has been observed to increase satiety and energy expenditure to a greater extent than carbohydrate and fat and can therefore reduce energy intake. However, it still has to be confirmed if this effect is permanent or transient over a longer period of time. Moreover, dietary intakes may significantly affect sleep when macronutrient intakes are manipulated. Since sleep deprivation has been recognized as a risk factor for obesity, improving sleep by a change in macronutrient intake would be promising in the treatment of obesity.

Study Timeline

• Study First Submitted: 2011-12-14
• Study Start: 2012-03
• Study First Submitted QC: 2012-03-07
• Study First Posted: 2012-03-12
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-02
• Last Update Posted: 2013-05-03
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• healthy
• age between 18-35 years
• BMI 18-27 kg/m2
• non-smoking
• weight stable (weight change < 3 kg during the last 6 months)
• no sleeping problems
• not using a more than moderate amount of alcohol (> 10 consumptions/wk)
• not using medication or supplements except for oral contraceptives in women

Exclusion Criteria

• not healthy
• do not meet the criteria for BMI and age
• smoking
• not being weight stable
• using medication or supplements except for oral contraceptives in women
• sleeping problems
• using a more than moderate alcohol consumption
• pregnant or lactating
• allergic for the used food items

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Protein intake of 5 energy percent	Differences in protein content of meals	-
Protein intake of 30 energy percent	Differences in protein content of meals	-

Primary Outcome Measures

Name	Time	Method
energy expenditure	48 hours
substrate oxidation	48 hours
sleep	48 hours

Secondary Outcome Measures

Name	Time	Method
body composition	48 hours
fat distribution	48 hours

Trial Locations

Locations (1)

Maastricht University, Department of Human Biology, Nutrition and Toxicology Research Institute Maastricht (NUTRIM); 🇳🇱 Maastricht, Netherlands