Effects of Beef Protein Consumption on Energy Intake
Primary Purpose
Obesity, Severe Overweight
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Differences in protein content (En%) of meals
Sponsored by

About this trial
This is an interventional treatment trial for Obesity focused on measuring Energy intake, Beef protein, Satiety, Protein leverage hypothesis
Eligibility 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
Sites / Locations
- Maastricht University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Protein intake of 5 energy percent (En%)
Protein intake of 15 En%
Protein intake of 30 En%
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01646749
First Posted
July 16, 2012
Last Updated
July 10, 2013
Sponsor
Maastricht University Medical Center
Collaborators
National Cattlemen's Beef Association
1. Study Identification
Unique Protocol Identification Number
NCT01646749
Brief Title
Effects of Beef Protein Consumption on Energy Intake
Official Title
Effects of Beef Protein Consumption on Energy Intake - The Protein Leverage Hypothesis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maastricht University Medical Center
Collaborators
National Cattlemen's Beef Association
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Severe Overweight
Keywords
Energy intake, Beef protein, Satiety, Protein leverage hypothesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Protein intake of 5 energy percent (En%)
Arm Type
Experimental
Arm Title
Protein intake of 15 En%
Arm Type
Experimental
Arm Title
Protein intake of 30 En%
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Differences in protein content (En%) of meals
Other Intervention Name(s)
All food items will be commercial available.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body weight change
Description
Body weight will be measured on day 1, 6 and 12. Subsequently, the change in body weight over time will be calculated.
Time Frame
11 days
Title
Appetite profile
Description
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.
Time Frame
12 consecutive days
Title
Energy intake
Description
Total energy intake over 12 days will be determined for each subject by adding energy intake during meals to energy intake from snack consumption.
Time Frame
12 consecutive days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margriet S Westerterp-Plantenga, Prof. dr.
Organizational Affiliation
Maastricht University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University
City
Maastricht
ZIP/Postal Code
6200 MD
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
15836464
Citation
Simpson SJ, Raubenheimer D. Obesity: the protein leverage hypothesis. Obes Rev. 2005 May;6(2):133-42. doi: 10.1111/j.1467-789X.2005.00178.x.
Results Reference
background
PubMed Identifier
16002798
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. doi: 10.1093/ajcn.82.1.41.
Results Reference
background
PubMed Identifier
22158729
Citation
Griffioen-Roose S, Mars M, Siebelink E, Finlayson G, Tome 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.
Results Reference
background
PubMed Identifier
22022472
Citation
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.
Results Reference
background
PubMed Identifier
11063440
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. doi: 10.1093/ajcn/72.5.1135.
Results Reference
background
PubMed Identifier
25183991
Citation
Martens EA, Tan SY, Mattes RD, Westerterp-Plantenga MS. No protein intake compensation for insufficient indispensable amino acid intake with a low-protein diet for 12 days. Nutr Metab (Lond). 2014 Aug 20;11:38. doi: 10.1186/1743-7075-11-38. eCollection 2014.
Results Reference
derived
PubMed Identifier
24760974
Citation
Martens EA, Tan SY, Dunlop MV, Mattes RD, Westerterp-Plantenga MS. Protein leverage effects of beef protein on energy intake in humans. Am J Clin Nutr. 2014 Jun;99(6):1397-406. doi: 10.3945/ajcn.113.078774. Epub 2014 Apr 23.
Results Reference
derived
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Effects of Beef Protein Consumption on Energy Intake
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