ClinicalTrials.gg
Status unknownNCT01551238Updated May 3, 2013

Energy Expenditure, Sleep and Macronutrients

An interventional study of Differences in protein content of meals and Differences in protein content of meals in Obesity, Overweight and Overnutrition, sponsored by Maastricht University Medical Center. Status unknown at 1 site in Netherlands. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-05-03.

Sponsored by Maastricht University Medical Center · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Obesity
  • Overweight
  • Overnutrition
  • Nutrition Disorders
  • Body Weight
  • Signs and Symptoms

Keywords

  • Energy expenditure
  • Sleep
  • Protein
  • Carbohydrate
03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 40 is below the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Maastricht University Medical Center is the lead sponsor of 853 studies on the registry; 114 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • healthy
  • age between 18-35 years
  • 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 in women

Exclusion criteria

Exclusion Criteria:

  • not healthy
  • do not meet the criteria for and age
  • smoking
  • not being weight stable
  • using medication or supplements except for oral in women
  • sleeping problems
  • using a more than moderate alcohol consumption
  • pregnant or lactating
  • allergic for the used food items
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Protein intake of 5 energy percent

    Dietary Supplement: Differences in protein content of meals

  • Experimental
    Protein intake of 30 energy percent

    Dietary Supplement: Differences in protein content of meals

Interventions

  • Dietary supplementDifferences in protein content of meals

    Differences in protein content (energy percent) of meals

  • Dietary supplementDifferences in protein content of meals

    Differences in protein content (energy percent) of meals

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What researchers measure

Primary outcomes

  1. energy expenditure

    Time frame: 48 hours

  2. substrate oxidation

    Time frame: 48 hours

  3. sleep

    Time frame: 48 hours

Secondary outcomes

  1. body composition

    Time frame: 48 hours

  2. fat distribution

    Time frame: 48 hours

07

Study locations

1 of 1 sites recruiting
  • Maastricht University, Department of Human Biology, Nutrition and Toxicology Research Institute Maastricht (NUTRIM)
    Maastricht, 6200 MD, Netherlands
    Recruiting
08

References and documents

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. PubMed 26367529 ↗
  • 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. PubMed 25466951 ↗
  • 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. PubMed 25330327 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01551238
Responsible party
Sponsor
First posted
Mar 12, 2012
Start date
Mar 2012
Primary completion
Dec 2013 (estimated)
Completion
Dec 2013 (estimated)
Last update
May 3, 2013

Study contacts

Hanne K. Gonnissen, Msc.
Contact
hkj.gonnissen@maastrichtuniversity.nl
+31433884596
Eveline A. Martens, Msc.
Contact
eap.martens@maastrichtuniversity.nl
+31433884596
Margriet S. Westerterp-Plantenga, Prof. dr.
principal investigator · Maastricht University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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