Effects of Beef Protein Consumption on Energy Intake

This study is not yet open for participant recruitment.

Verified July 2012 by Maastricht University Medical Center

Sponsor:

Collaborator:

National Cattlemen's Beef Association

Information provided by (Responsible Party):

Eveline Martens, Maastricht University Medical Center

ClinicalTrials.gov Identifier:

NCT01646749

First received: July 16, 2012

Last updated: July 18, 2012

Last verified: July 2012

History of Changes

Purpose

The purpose of this study is to determine ad libitum daily energy intake, body weight changes and appetite profile in response to protein/carbohydrate and fat ratio over 12 consecutive days, and in relation to age, gender, body mass index (BMI) and fat mass and obesity-associated (FTO) gene alleles.

Condition	Intervention
Obesity Severe Overweight	Dietary Supplement: Differences in protein content (En%) 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:	Effects of Beef Protein Consumption on Energy Intake - The Protein Leverage Hypothesis

Resource links provided by NLM:

MedlinePlus related topics: Obesity

U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:

Body weight change [ Time Frame: 11 days ] [ Designated as safety issue: No ]
Body weight will be measured on day 1, 6 and 12. Subsequently, the change in body weight over time will be calculated.
Appetite profile [ Time Frame: 12 consecutive days ] [ Designated as safety issue: No ]
Appetite profile will be measured by means of questionnaires: visual analogue scales (VAS). Area under the curve (AUC) will be calculated over 12 consecutive days.
Energy intake [ Time Frame: 12 consecutive days ] [ Designated as safety issue: No ]
Total energy intake over 12 days will be determined for each subject by adding energy intake during meals to energy intake from snack consumption.

Estimated Enrollment:	30
Study Start Date:	September 2012
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Protein intake of 5 energy percent (En%)	Dietary Supplement: Differences in protein content (En%) of meals The three applied conditions will differ in the relative protein content of the meals, including 5 En%, 15 En% and 30 En% from protein. Beef protein will be used as main meat protein source in the 15 En% and 30 En% protein conditions. The resulting macronutrient compositions of the diets will be En% Protein/Carbohydrate/Fat; 5/60/35, 15/50/35, and 30/35/35. All meals (breakfast, lunch, dinner) within each condition will have the same macronutrient composition. All food items, and the energy density, weight and volume of the meals will be the same between conditions. All snack items will be very low in protein content. Other Name: All food items will be commercial available.
Experimental: Protein intake of 15 En%	Dietary Supplement: Differences in protein content (En%) of meals The three applied conditions will differ in the relative protein content of the meals, including 5 En%, 15 En% and 30 En% from protein. Beef protein will be used as main meat protein source in the 15 En% and 30 En% protein conditions. The resulting macronutrient compositions of the diets will be En% Protein/Carbohydrate/Fat; 5/60/35, 15/50/35, and 30/35/35. All meals (breakfast, lunch, dinner) within each condition will have the same macronutrient composition. All food items, and the energy density, weight and volume of the meals will be the same between conditions. All snack items will be very low in protein content. Other Name: All food items will be commercial available.
Experimental: Protein intake of 30 En%	Dietary Supplement: Differences in protein content (En%) of meals The three applied conditions will differ in the relative protein content of the meals, including 5 En%, 15 En% and 30 En% from protein. Beef protein will be used as main meat protein source in the 15 En% and 30 En% protein conditions. The resulting macronutrient compositions of the diets will be En% Protein/Carbohydrate/Fat; 5/60/35, 15/50/35, and 30/35/35. All meals (breakfast, lunch, dinner) within each condition will have the same macronutrient composition. All food items, and the energy density, weight and volume of the meals will be the same between conditions. All snack items will be very low in protein content. Other Name: All food items will be commercial available.

Detailed Description:

The protein leverage hypothesis requires specific evidence whether energy intake would depend on a possible protein intake target in humans. Meat protein as complete protein may show most beneficial effects on variables regarding 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:

Healthy
Age 18-70 years
BMI 18-35 kg/m2
Non-smoking
Weight stable

Exclusion Criteria:

Smoking
Use of medication
More than moderate alcohol consumption
Vegetarian

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01646749

Contacts

Contact: Eveline AP Martens, Msc.	+31433884596	eap.martens@maastrichtuniversity.nl
Contact: Margriet S Westerterp-Plantenga, Prof. dr.	+31433881566	m.westerterp@maastrichtuniversity.nl

Locations

Netherlands
Maastricht University	Not yet recruiting
Maastricht, Netherlands, 6200 MD
Contact: Eveline AP Martens, Msc. +31433884596 eap.martens@maastrichtuniversity.nl
Contact: Margriet S Westerterp-Plantenga, Prof. dr. +31433881566 m.westerterp@maastrichtuniversity.nl
Principal Investigator: Margriet S Westerterp-Plantenga, Prof. dr.

Sponsors and Collaborators

Maastricht University Medical Center

National Cattlemen's Beef Association

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.

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.

Griffioen-Roose S, Mars M, Siebelink E, Finlayson G, Tomé D, de Graaf C. Protein status elicits compensatory changes in food intake and food preferences. Am J Clin Nutr. 2012 Jan;95(1):32-8. Epub 2011 Dec 7.

Gosby AK, Conigrave AD, Lau NS, Iglesias MA, Hall RM, Jebb SA, Brand-Miller J, Caterson ID, Raubenheimer D, Simpson SJ. Testing protein leverage in lean humans: a randomised controlled experimental study. PLoS One. 2011;6(10):e25929. Epub 2011 Oct 12.

Mikkelsen PB, Toubro S, Astrup A. Effect of fat-reduced diets on 24-h energy expenditure: comparisons between animal protein, vegetable protein, and carbohydrate. Am J Clin Nutr. 2000 Nov;72(5):1135-41.

Responsible Party:	Eveline Martens, PhD student, Maastricht University Medical Center
ClinicalTrials.gov Identifier:	NCT01646749 History of Changes
Other Study ID Numbers:	NL41371
Study First Received:	July 16, 2012
Last Updated:	July 18, 2012
Health Authority:	Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Maastricht University Medical Center:

Energy intake
Beef protein
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 19, 2013

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