NCT01551238

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 12, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

May 3, 2013

Status Verified

May 1, 2013

Enrollment Period

1.8 years

First QC Date

December 14, 2011

Last Update Submit

May 2, 2013

Conditions

ObesityOverweightOvernutritionNutrition DisordersBody WeightSigns and Symptoms

Keywords

Energy expenditureSleepProteinCarbohydrate

Outcome Measures

Primary Outcomes (3)

  • energy expenditure

    48 hours

  • substrate oxidation

    48 hours

  • sleep

    48 hours

Secondary Outcomes (2)

  • body composition

    48 hours

  • fat distribution

    48 hours

Study Arms (2)

Protein intake of 5 energy percent

EXPERIMENTAL
Dietary Supplement: Differences in protein content of meals

Protein intake of 30 energy percent

EXPERIMENTAL
Dietary Supplement: Differences in protein content of meals

Interventions

Differences in protein content of mealsDIETARY_SUPPLEMENT

Differences in protein content (energy percent) of meals

Protein intake of 5 energy percent

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Maastricht, 6200 MD, Netherlands

RECRUITING

Related Publications (3)

  • 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.

    PMID: 26367529DERIVED

  • 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.

    PMID: 25466951DERIVED

  • 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.

    PMID: 25330327DERIVED

MeSH Terms

Conditions

ObesityOverweightOvernutritionNutrition DisordersBody WeightSigns and Symptoms

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesPathological Conditions, Signs and Symptoms

Study Officials

  • Margriet S. Westerterp-Plantenga, Prof. dr.

    Maastricht University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanne K. Gonnissen, Msc.

CONTACT

+31433884596hkj.gonnissen@maastrichtuniversity.nl

Eveline A. Martens, Msc.

CONTACT

+31433884596eap.martens@maastrichtuniversity.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2011

First Posted

March 12, 2012

Study Start

March 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

May 3, 2013

Record last verified: 2013-05

Locations

NL(1)