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Energy Expenditure, Sleep and Macronutrients

This study is currently recruiting participants.
Verified May 2013 by Maastricht University Medical Center
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01551238
First received: December 14, 2011
Last updated: May 2, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
 Dietary Supplement: Differences in protein content of meals

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Energy Expenditure and Sleep in Response to Protein/Carbohydrate and Fat Ratio

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • energy expenditure [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • substrate oxidation [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • sleep [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • body composition [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • fat distribution [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: March 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01551238

Contacts
Contact: Hanne K. Gonnissen, Msc. +31433884596 hkj.gonnissen@maastrichtuniversity.nl
Contact: Eveline A. Martens, Msc. +31433884596 eap.martens@maastrichtuniversity.nl

Locations
Netherlands
Maastricht University, Department of Human Biology, Nutrition and Toxicology Research Institute Maastricht (NUTRIM) Recruiting
Maastricht, Netherlands, 6200 MD
Contact: Hanne K. Gonnissen, Msc.     +31433884596     hkj.gonnissen@maastrichtuniversity.nl    
Contact: Eveline A. Martens, Msc.     +31433884596     eap.martens@maastrichtuniversity.nl    
Principal Investigator: Margriet S. Westerterp-Plantenga, Prof. dr.            
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Margriet S. Westerterp-Plantenga, Prof. dr. Maastricht University
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01551238     History of Changes
Other Study ID Numbers: NL39152
Study First Received: December 14, 2011
Last Updated: May 2, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Energy expenditure
Sleep
Protein
Carbohydrate

Additional relevant MeSH terms:
Body Weight
Nutrition Disorders
Obesity
 Signs and Symptoms
Overweight
Overnutrition

ClinicalTrials.gov processed this record on May 19, 2013