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Dietary Protein Requirements on Unbalanced Diets

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01320189
First Posted: March 22, 2011
Last Update Posted: July 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eveline Martens, Maastricht University Medical Center
  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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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 Eveline Martens, Maastricht University Medical Center:

Primary Outcome Measures:
  • energy intake [ Time Frame: 12 consecutive days ]
  • protein intake [ Time Frame: 12 consecutive days ]
  • energy balance [ Time Frame: 12 consecutive days ]
  • appetite profile [ Time Frame: 12 consecutive days ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: March 16, 2011
First Posted: March 22, 2011
Last Update Posted: July 11, 2013
Last Verified: July 2013

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

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms