Effects of Beef Protein Consumption on Energy Intake
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Sep 2012
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2012
CompletedFirst Posted
Study publicly available on registry
July 20, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedJuly 11, 2013
July 1, 2013
5 months
July 16, 2012
July 10, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
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
Study Arms (3)
Protein intake of 5 energy percent (En%)
EXPERIMENTALProtein intake of 15 En%
EXPERIMENTALProtein intake of 30 En%
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- Healthy
- Age 18-70 years
- BMI 18-35 kg/m2
- Non-smoking
- Weight stable
You may not qualify if:
- Smoking
- Use of medication
- More than moderate alcohol consumption
- Vegetarian
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maastricht University
Maastricht, 6200 MD, Netherlands
Related Publications (7)
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.
PMID: 15836464BACKGROUNDWeigle 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.
PMID: 16002798BACKGROUNDGriffioen-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.
PMID: 22158729BACKGROUNDGosby 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.
PMID: 22022472BACKGROUNDMikkelsen 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.
PMID: 11063440BACKGROUNDMartens 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.
PMID: 25183991DERIVEDMartens 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.
PMID: 24760974DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Margriet S Westerterp-Plantenga, Prof. dr.
Maastricht University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD student
Study Record Dates
First Submitted
July 16, 2012
First Posted
July 20, 2012
Study Start
September 1, 2012
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
July 11, 2013
Record last verified: 2013-07