- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01551238
Energy Expenditure, Sleep and Macronutrients
May 2, 2013 updated by: Maastricht University Medical Center
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.
Study Overview
Status
Unknown
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hanne K. Gonnissen, Msc.
- Phone Number: +31433884596
- Email: hkj.gonnissen@maastrichtuniversity.nl
Study Contact Backup
- Name: Eveline A. Martens, Msc.
- Phone Number: +31433884596
- Email: eap.martens@maastrichtuniversity.nl
Study Locations
-
-
-
Maastricht, Netherlands, 6200 MD
- Recruiting
- Maastricht University, Department of Human Biology, Nutrition and Toxicology Research Institute Maastricht (NUTRIM)
-
Contact:
- Hanne K. Gonnissen, Msc.
- Phone Number: +31433884596
- Email: hkj.gonnissen@maastrichtuniversity.nl
-
Contact:
- Eveline A. Martens, Msc.
- Phone Number: +31433884596
- Email: eap.martens@maastrichtuniversity.nl
-
Principal Investigator:
- Margriet S. Westerterp-Plantenga, Prof. dr.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Protein intake of 5 energy percent
|
Differences in protein content (energy percent) of meals
|
Experimental: Protein intake of 30 energy percent
|
Differences in protein content (energy percent) of meals
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
energy expenditure
Time Frame: 48 hours
|
48 hours
|
substrate oxidation
Time Frame: 48 hours
|
48 hours
|
sleep
Time Frame: 48 hours
|
48 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
body composition
Time Frame: 48 hours
|
48 hours
|
fat distribution
Time Frame: 48 hours
|
48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Margriet S. Westerterp-Plantenga, Prof. dr., Maastricht University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (Anticipated)
December 1, 2013
Study Completion (Anticipated)
December 1, 2013
Study Registration Dates
First Submitted
December 14, 2011
First Submitted That Met QC Criteria
March 7, 2012
First Posted (Estimate)
March 12, 2012
Study Record Updates
Last Update Posted (Estimate)
May 3, 2013
Last Update Submitted That Met QC Criteria
May 2, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL39152
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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