Effects of Beef Protein Consumption on Energy Intake

Obesity Clinical Trial

Official title:

Effects of Beef Protein Consumption on Energy Intake - The Protein Leverage Hypothesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01646749
• Other study ID #: NL41371
• Status: Completed
• Phase: N/A
• First received: July 16, 2012
• Last updated: July 10, 2013
• Start date: September 2012
• Est. completion date: February 2013

Study information

• Verified date: July 2013
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Severe Overweight

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	National Cattlemen's Beef Association

Country where clinical trial is conducted

Netherlands, 

References & Publications (5)

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. doi: 10.1371/journal.pone.0025929. Epub 2011 Oct 12. — View Citation

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. doi: 10.3945/ajcn.111.020503. Epub 2011 Dec 7. — View Citation

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. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight change	Body weight will be measured on day 1, 6 and 12. Subsequently, the change in body weight over time will be calculated.	11 days	No
Primary	Appetite profile	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.	12 consecutive days	No
Primary	Energy intake	Total energy intake over 12 days will be determined for each subject by adding energy intake during meals to energy intake from snack consumption.	12 consecutive days	No