Dietary Protein Requirements on Unbalanced Diets

Study Overview
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Brief Summary
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The objective of this study is to determine ad libitum daily energy and protein intake, energy balance and appetite profile in response to protein/carbohydrate and fat ratio over 12 consecutive days, also as a function of age, gender, BMI and FTO polymorphisms.

Detailed Description
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Following the protein leverage hypothesis, energy intake may be a derivative of protein intake. Therefore, in response to an unbalanced menu relative to the usual daily intake target, protein intake should be prioritized. Individuals may over-consume carbohydrate and fat of a menu containing a lower ratio of protein to carbohydrate and fat until the daily intake target amount of protein is ingested, and not the target of total energy intake because of a deficit of protein intake. In contrast, individuals may under-consume energy when the menu has an increased protein to carbohydrate and fat ratio. The protein leverage hypothesis requires evidence for why protein intake is more important than carbohydrate or fat in relation to food intake regulation.

Official Title
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Dietary Protein Requirements and Caloric Over-consumption on Unbalanced Diets

Conditions
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Obesity, Overweight

Intervention / Treatment
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* Dietary Supplement: Differences in protein content of meals


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI 18-35 kg/m2 age between 18-70 years healthy non-smoking not using a more than moderate amount of alcohol (> 10 consumptions/wk) weight stable (weight change < 3 kg during the last 6 months) not using medication or supplements except for oral contraceptives in women Exclusion Criteria: not healthy smoking using a more than moderate amount of alcohol not being weight stable using medication or supplements except for oral contraceptives in women do not meet the criteria for BMI and age pregnant or lactating allergic for the used food items

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<br> | Dietary Supplement: Differences in protein content of meals<br>* Differences in protein content (energy percent) of meals<br>|
| Experimental: Protein intake of 15 energy percent<br> | Dietary Supplement: Differences in protein content of meals<br>* Differences in protein content (energy percent) of meals<br>|
| Experimental: Protein intake of 30 energy percent<br> | Dietary Supplement: Differences in protein content of meals<br>* Differences in protein content (energy percent) of meals<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| energy intake |  | 12 consecutive days | 
| protein intake |  | 12 consecutive days | 
| energy balance |  | 12 consecutive days | 
| appetite profile |  | 12 consecutive days | 

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