Energy Expenditure, Sleep and Macronutrients

This study is currently recruiting participants. (see Contacts and Locations)
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

December 14, 2011
May 2, 2013
March 2012
December 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01551238 on ClinicalTrials.gov Archive Site
  • body composition [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • fat distribution [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Energy Expenditure, Sleep and Macronutrients
Energy Expenditure and Sleep in Response to Protein/Carbohydrate and Fat Ratio

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Obesity
  • Overweight
  • Overnutrition
  • Nutrition Disorders
  • Body Weight
  • Signs and Symptoms
Dietary Supplement: Differences in protein content of meals
Differences in protein content (energy percent) of meals
  • Experimental: Protein intake of 5 energy percent
    Intervention: Dietary Supplement: Differences in protein content of meals
  • Experimental: Protein intake of 30 energy percent
    Intervention: Dietary Supplement: Differences in protein content of meals
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 35 Years
Yes
Contact: Hanne K. Gonnissen, Msc. +31433884596 hkj.gonnissen@maastrichtuniversity.nl
Contact: Eveline A. Martens, Msc. +31433884596 eap.martens@maastrichtuniversity.nl
Netherlands
 
NCT01551238
NL39152
No
Maastricht University Medical Center
Maastricht University Medical Center
Not Provided
Principal Investigator: Margriet S. Westerterp-Plantenga, Prof. dr. Maastricht University
Maastricht University Medical Center
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP