NCT01320189

Brief Summary

The objective of this study is to determine ad libitum daily energy and protein intake, energy balance and appetite profile in response to protein/carbohydrate and fat ratio over 12 consecutive days, also as a function of age, gender, BMI and FTO polymorphisms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started May 2011

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

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

March 16, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 22, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

July 11, 2013

Status Verified

July 1, 2013

Enrollment Period

9 months

First QC Date

March 16, 2011

Last Update Submit

July 10, 2013

Conditions

ObesityOverweight

Keywords

Energy intakeProtein requirementSatietyProtein leverage hypothesis

Outcome Measures

Primary Outcomes (4)

  • energy intake

    12 consecutive days

  • protein intake

    12 consecutive days

  • energy balance

    12 consecutive days

  • appetite profile

    12 consecutive days

Study Arms (3)

Protein intake of 5 energy percent

EXPERIMENTAL
Dietary Supplement: Differences in protein content of meals

Protein intake of 15 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 15 energy percentProtein intake of 30 energy percentProtein intake of 5 energy percent

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI 18-35 kg/m2
  • age between 18-70 years
  • healthy
  • non-smoking
  • not using a more than moderate amount of alcohol (\> 10 consumptions/wk)
  • weight stable (weight change \< 3 kg during the last 6 months)
  • not using medication or supplements except for oral contraceptives in women

You may not qualify if:

  • not healthy
  • smoking
  • using a more than moderate amount of alcohol
  • not being weight stable
  • using medication or supplements except for oral contraceptives in women
  • do not meet the criteria for BMI and age
  • 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, Maastricht, 6200 MD, Netherlands

Location

Related Publications (6)

  • Simpson SJ, Raubenheimer D. Obesity: the protein leverage hypothesis. Obes Rev. 2005 May;6(2):133-42. doi: 10.1111/j.1467-789X.2005.00178.x.

    PMID: 15836464RESULT

  • Sorensen A, Mayntz D, Raubenheimer D, Simpson SJ. Protein-leverage in mice: the geometry of macronutrient balancing and consequences for fat deposition. Obesity (Silver Spring). 2008 Mar;16(3):566-71. doi: 10.1038/oby.2007.58. Epub 2008 Jan 17.

    PMID: 18239565RESULT

  • Weigle DS, Breen PA, Matthys CC, Callahan HS, Meeuws KE, Burden VR, Purnell JQ. A high-protein diet induces sustained reductions in appetite, ad libitum caloric intake, and body weight despite compensatory changes in diurnal plasma leptin and ghrelin concentrations. Am J Clin Nutr. 2005 Jul;82(1):41-8. doi: 10.1093/ajcn.82.1.41.

    PMID: 16002798RESULT

  • Leidy HJ, Tang M, Armstrong CL, Martin CB, Campbell WW. The effects of consuming frequent, higher protein meals on appetite and satiety during weight loss in overweight/obese men. Obesity (Silver Spring). 2011 Apr;19(4):818-24. doi: 10.1038/oby.2010.203. Epub 2010 Sep 16.

    PMID: 20847729RESULT

  • Martens EA, Tan SY, Mattes RD, Westerterp-Plantenga MS. No protein intake compensation for insufficient indispensable amino acid intake with a low-protein diet for 12 days. Nutr Metab (Lond). 2014 Aug 20;11:38. doi: 10.1186/1743-7075-11-38. eCollection 2014.

    PMID: 25183991DERIVED

  • Martens EA, Lemmens SG, Westerterp-Plantenga MS. Protein leverage affects energy intake of high-protein diets in humans. Am J Clin Nutr. 2013 Jan;97(1):86-93. doi: 10.3945/ajcn.112.046540. Epub 2012 Dec 5.

    PMID: 23221572DERIVED

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

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

    Maastricht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 16, 2011

First Posted

March 22, 2011

Study Start

May 1, 2011

Primary Completion

February 1, 2012

Study Completion

April 1, 2012

Last Updated

July 11, 2013

Record last verified: 2013-07

Locations

NL(1)