Clinical trial NCT01551238: Energy Expenditure, Sleep and Macronutrients
Official title: Energy Expenditure and Sleep in Response to Protein/Carbohydrate and Fat Ratio
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Keywords: Energy expenditure
Sleep
Protein
Carbohydrate
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2012-03-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: energy expenditure
timeFrame: 48 hours
measure: substrate oxidation
timeFrame: 48 hours
measure: sleep
timeFrame: 48 hours
Secondary outcomes:
measure: body composition
timeFrame: 48 hours
measure: fat distribution
timeFrame: 48 hours
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University, Department of Human Biology, Nutrition and Toxicology Research Institute Maastricht (NUTRIM)
Study officials:
affiliation: Maastricht University
name: Margriet S. Westerterp-Plantenga, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.