Dietary Protein Requirements on Unbalanced Diets - Full Text View

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:

MedlinePlus related topics: Dietary Proteins Obesity

U.S. FDA Resources

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 ]

Estimated Enrollment:	90
Study Start Date:	May 2011
Estimated Study Completion Date:	September 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:

Simpson SJ, Raubenheimer D. Obesity: the protein leverage hypothesis. Obes Rev. 2005 May;6(2):133-42. Review.

Sørensen 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. Epub 2008 Jan 17.

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.

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). 2010 Sep 16; [Epub ahead of print]

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Sofie Lemmens, 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 4, 2012
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 May 21, 2013