Effects of Beef Protein Consumption on Energy Intake

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity, Severe Overweight

Intervention / Treatment
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* Dietary Supplement: Differences in protein content (En%) of meals


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Protein intake of 5 energy percent (En%)<br> | Dietary Supplement: Differences in protein content (En%) of meals<br>* 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.<br>* Other names: All food items will be commercial available.;|
| Experimental: Protein intake of 15 En%<br> | Dietary Supplement: Differences in protein content (En%) of meals<br>* 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.<br>* Other names: All food items will be commercial available.;|
| Experimental: Protein intake of 30 En%<br> | Dietary Supplement: Differences in protein content (En%) of meals<br>* 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.<br>* Other names: All food items will be commercial available.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Energy intake, Beef protein, Satiety, Protein leverage hypothesis