Dietary Protein Requirements on Unbalanced Diets

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eveline Martens, Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01320189
First received: March 16, 2011
Last updated: July 10, 2013
Last verified: July 2013

March 16, 2011
July 10, 2013
May 2011
February 2012   (final data collection date for primary outcome measure)
  • energy intake [ Time Frame: 12 consecutive days ] [ Designated as safety issue: No ]
  • protein intake [ Time Frame: 12 consecutive days ] [ Designated as safety issue: No ]
  • energy balance [ Time Frame: 12 consecutive days ] [ Designated as safety issue: No ]
  • appetite profile [ Time Frame: 12 consecutive days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01320189 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Dietary Protein Requirements on Unbalanced Diets
Dietary Protein Requirements and Caloric Over-consumption on Unbalanced Diets

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.

Following the protein leverage hypothesis, energy intake may be a derivative of protein intake. Therefore, in response to an unbalanced menu relative to the usual daily intake target, protein intake should be prioritized. Individuals may over-consume carbohydrate and fat of a menu containing a lower ratio of protein to carbohydrate and fat until the daily intake target amount of protein is ingested, and not the target of total energy intake because of a deficit of protein intake. In contrast, individuals may under-consume energy when the menu has an increased protein to carbohydrate and fat ratio. The protein leverage hypothesis requires evidence for why protein intake is more important than carbohydrate or fat in relation to food intake regulation.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Obesity
  • Overweight
Dietary Supplement: Differences in protein content of meals
Differences in protein content (energy percent) of meals
  • Experimental: Protein intake of 5 energy percent
    Intervention: Dietary Supplement: Differences in protein content of meals
  • Experimental: Protein intake of 15 energy percent
    Intervention: Dietary Supplement: Differences in protein content of meals
  • Experimental: Protein intake of 30 energy percent
    Intervention: Dietary Supplement: Differences in protein content of meals

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
81
April 2012
February 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01320189
NL36167
No
Eveline Martens, Maastricht University Medical Center
Maastricht University Medical Center
Not Provided
Principal Investigator: Margriet S. Westerterp-Plantenga, Prof. dr. Maastricht University
Maastricht University Medical Center
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP