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
  Purpose

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.


Condition Intervention
Obesity
Overweight
Dietary Supplement: Differences in protein content of meals

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Dietary Protein Requirements and Caloric Over-consumption on Unbalanced Diets

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • 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 ]

Enrollment: 81
Study Start Date: May 2011
Study Completion Date: April 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Protein intake of 5 energy percent Dietary Supplement: Differences in protein content of meals
Differences in protein content (energy percent) of meals
Experimental: Protein intake of 15 energy percent Dietary Supplement: Differences in protein content of meals
Differences in protein content (energy percent) of meals
Experimental: Protein intake of 30 energy percent Dietary Supplement: Differences in protein content of meals
Differences in protein content (energy percent) of meals

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01320189

Locations
Netherlands
Maastricht University, Department of Human Biology, Nutrition and Toxicology Research Institute Maastricht (NUTRIM)
Maastricht, Netherlands, 6200 MD
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Margriet S. Westerterp-Plantenga, Prof. dr. Maastricht University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eveline Martens, PhD, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01320189     History of Changes
Other Study ID Numbers: NL36167
Study First Received: March 16, 2011
Last Updated: July 10, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Energy intake
Protein requirement
Satiety
Protein leverage hypothesis

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 22, 2014