Energy Expenditure, Sleep and Macronutrients

Sponsor

Maastricht University Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT01551238

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Overweight Overnutrition Nutrition Disorders Body Weight Signs and Symptoms	Dietary Supplement: Differences in protein content of meals Dietary Supplement: Differences in protein content of meals	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2012

Anticipated Primary Completion Date :

Dec 1, 2013

Anticipated Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Protein intake of 5 energy percent	Dietary Supplement: Differences in protein content of meals Differences in protein content (energy percent) of meals
Experimental: Protein intake of 30 energy percent	Dietary Supplement: Differences in protein content of meals Differences in protein content (energy percent) of meals

Arm

Intervention/Treatment

Experimental: Protein intake of 5 energy percent

Dietary Supplement: Differences in protein content of meals

Differences in protein content (energy percent) of meals

Experimental: Protein intake of 30 energy percent

Dietary Supplement: Differences in protein content of meals

Differences in protein content (energy percent) of meals

Outcome Measures

Primary Outcome Measures

energy expenditure [48 hours]
substrate oxidation [48 hours]
sleep [48 hours]

Secondary Outcome Measures

body composition [48 hours]
fat distribution [48 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maastricht University, Department of Human Biology, Nutrition and Toxicology Research Institute Maastricht (NUTRIM)	Maastricht		Netherlands	6200 MD

Sponsors and Collaborators

Maastricht University Medical Center

Investigators

Principal Investigator: Margriet S. Westerterp-Plantenga, Prof. dr., Maastricht University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Maastricht University Medical Center

ClinicalTrials.gov Identifier:

NCT01551238

Other Study ID Numbers:

NL39152

First Posted:

Mar 12, 2012

Last Update Posted:

May 3, 2013

Last Verified:

May 1, 2013

Keywords provided by Maastricht University Medical Center

Additional relevant MeSH terms:

Study Results

No Results Posted as of May 3, 2013