Energy Expenditure, Sleep and Macronutrients

NCT ID: NCT01551238

Last Updated: 2013-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Obesity Overweight Overnutrition Nutrition Disorders Body Weight Signs and Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Protein intake of 5 energy percent

Group Type EXPERIMENTAL

Differences in protein content of meals

Intervention Type DIETARY_SUPPLEMENT

Differences in protein content (energy percent) of meals

Protein intake of 30 energy percent

Group Type EXPERIMENTAL

Differences in protein content of meals

Intervention Type DIETARY_SUPPLEMENT

Differences in protein content (energy percent) of meals

Interventions

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Differences in protein content of meals

Differences in protein content (energy percent) of meals

Intervention Type DIETARY_SUPPLEMENT

Differences in protein content of meals

Differences in protein content (energy percent) of meals

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Margriet S. Westerterp-Plantenga, Prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Maastricht University

Locations

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Maastricht University, Department of Human Biology, Nutrition and Toxicology Research Institute Maastricht (NUTRIM)

Maastricht, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Hanne K. Gonnissen, Msc.

Role: CONTACT

+31433884596

Eveline A. Martens, Msc.

Role: CONTACT

+31433884596

Facility Contacts

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Hanne K. Gonnissen, Msc.

Role: primary

+31433884596

Eveline A. Martens, Msc.

Role: backup

+31433884596

References

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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.

Reference Type DERIVED
PMID: 26367529 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25466951 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25330327 (View on PubMed)

Other Identifiers

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NL39152

Identifier Type: -

Identifier Source: org_study_id

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