Energy Expenditure, Sleep and Macronutrients
Primary Purpose
Obesity, Overweight, Overnutrition
Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Differences in protein content of meals
Differences in protein content of meals
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Energy expenditure, Sleep, Protein, Carbohydrate
Eligibility 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
Sites / Locations
- Maastricht University, Department of Human Biology, Nutrition and Toxicology Research Institute Maastricht (NUTRIM)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Protein intake of 5 energy percent
Protein intake of 30 energy percent
Arm Description
Outcomes
Primary Outcome Measures
energy expenditure
substrate oxidation
sleep
Secondary Outcome Measures
body composition
fat distribution
Full Information
NCT ID
NCT01551238
First Posted
December 14, 2011
Last Updated
May 2, 2013
Sponsor
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01551238
Brief Title
Energy Expenditure, Sleep and Macronutrients
Official Title
Energy Expenditure and Sleep in Response to Protein/Carbohydrate and Fat Ratio
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight, Overnutrition, Nutrition Disorders, Body Weight, Signs and Symptoms
Keywords
Energy expenditure, Sleep, Protein, Carbohydrate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Protein intake of 5 energy percent
Arm Type
Experimental
Arm Title
Protein intake of 30 energy percent
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Differences in protein content of meals
Intervention Description
Differences in protein content (energy percent) of meals
Intervention Type
Dietary Supplement
Intervention Name(s)
Differences in protein content of meals
Intervention Description
Differences in protein content (energy percent) of meals
Primary Outcome Measure Information:
Title
energy expenditure
Time Frame
48 hours
Title
substrate oxidation
Time Frame
48 hours
Title
sleep
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
body composition
Time Frame
48 hours
Title
fat distribution
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hanne K. Gonnissen, Msc.
Phone
+31433884596
Email
hkj.gonnissen@maastrichtuniversity.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Eveline A. Martens, Msc.
Phone
+31433884596
Email
eap.martens@maastrichtuniversity.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margriet S. Westerterp-Plantenga, Prof. dr.
Organizational Affiliation
Maastricht University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University, Department of Human Biology, Nutrition and Toxicology Research Institute Maastricht (NUTRIM)
City
Maastricht
ZIP/Postal Code
6200 MD
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanne K. Gonnissen, Msc.
Phone
+31433884596
Email
hkj.gonnissen@maastrichtuniversity.nl
First Name & Middle Initial & Last Name & Degree
Eveline A. Martens, Msc.
Phone
+31433884596
Email
eap.martens@maastrichtuniversity.nl
First Name & Middle Initial & Last Name & Degree
Margriet S. Westerterp-Plantenga, Prof. dr.
12. IPD Sharing Statement
Citations:
PubMed Identifier
26367529
Citation
Hursel R, Martens EA, Gonnissen HK, Hamer HM, Senden JM, van Loon LJ, Westerterp-Plantenga MS. Prolonged Adaptation to a Low or High Protein Diet Does Not Modulate Basal Muscle Protein Synthesis Rates - A Substudy. PLoS One. 2015 Sep 14;10(9):e0137183. doi: 10.1371/journal.pone.0137183. eCollection 2015.
Results Reference
derived
PubMed Identifier
25466951
Citation
Martens EA, Gonnissen HK, Gatta-Cherifi B, Janssens PL, Westerterp-Plantenga MS. Maintenance of energy expenditure on high-protein vs. high-carbohydrate diets at a constant body weight may prevent a positive energy balance. Clin Nutr. 2015 Oct;34(5):968-75. doi: 10.1016/j.clnu.2014.10.007. Epub 2014 Nov 8.
Results Reference
derived
PubMed Identifier
25330327
Citation
Martens EA, Gatta-Cherifi B, Gonnissen HK, Westerterp-Plantenga MS. The potential of a high protein-low carbohydrate diet to preserve intrahepatic triglyceride content in healthy humans. PLoS One. 2014 Oct 16;9(10):e109617. doi: 10.1371/journal.pone.0109617. eCollection 2014.
Results Reference
derived
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Energy Expenditure, Sleep and Macronutrients
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