Energy Expenditure, Sleep and Macronutrients

Obesity Clinical Trial

Official title:

Energy Expenditure and Sleep in Response to Protein/Carbohydrate and Fat Ratio

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01551238
• Other study ID #: NL39152
• Status: Recruiting
• Phase: N/A
• First received: December 14, 2011
• Last updated: May 2, 2013
• Start date: March 2012
• Est. completion date: December 2013

Study information

• Verified date: May 2013
• Source: Maastricht University Medical Center
• Contact: Hanne K. Gonnissen, Msc.
• Phone: +31433884596
• Email: hkj.gonnissen[@]maastrichtuniversity.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Nutrition Disorders
• Obesity
• Overnutrition
• Overweight
• Signs and Symptoms

Intervention

Dietary Supplement:
• Differences in protein content of meals
Differences in protein content (energy percent) of meals
• Differences in protein content of meals
Differences in protein content (energy percent) of meals

Locations

Country	Name	City	State
Netherlands	Maastricht University, Department of Human Biology, Nutrition and Toxicology Research Institute Maastricht (NUTRIM)	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	energy expenditure		48 hours	No
Primary	substrate oxidation		48 hours	No
Primary	sleep		48 hours	No
Secondary	body composition		48 hours	No
Secondary	fat distribution		48 hours	No