Factors That Determine the Responses to Food Ingestion: Protein Load

Study Overview
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Brief Summary
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Aim: to determine to what extent meal composition influences postprandial sensations. Experimental design: randomized cross-ower study comparing the responses to a high protein (47.3% protein, 39.4% carbohydrates, 13.3% lipids) versus a balanced (22.2% protein, 67.85% carbohydrates, 9.95% lipids). In each participant the meals (both containing 20.8 g protein and diluted to a volume of 200 mL) will be tested on separate days. Healthy, non-obese participants (8 men and 8 women) will be instructed to eat a standard dinner the day before, to consume a standard breakfast at home after overnight fast, and to report to the laboratory, where the test meal will be administered 3 h after breakfast. Studies will be conducted in a quiet, isolated room with participants sitting on a chair. Perception will be measured at 5 min intervals 10 min before and 20 min after ingestion, at 10 min intervals up to 60 min after the meal and at 30 min up to 120 min after ingestion. Blood samples for biochemical and hormonal determinations will be taken before and after ingestion.

Official Title
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Factores Que Determinan la Respuesta a la Ingesta: Efecto de la Carga Proteica

Conditions
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Healthy

Intervention / Treatment
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* Other: High-protein supplement
* Other: Balanced supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: non-obese Exclusion Criteria: history of gastrointestinal symptoms prior obesity use of medications history of anosmia and ageusia current dieting alcohol abuse psychological disorders eating disorders

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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-protein supplement<br>The high-protein supplements contains 47.3% protein, 39.4% carbohydrates, 13.3% lipids. A dose containing 20.8 g protein and diluted to a volume of 200 mL will be administered (187 Kcal). | Other: High-protein supplement<br>* High protein supplement 200 mL<br>|
| Active Comparator: Balanced supplement<br>The high-protein supplements 22.2% protein, 67.85% carbohydrates, 9.95% lipids. A dose containing 20.8 g protein and diluted to a volume of 200 mL will be administered (399.3 Kcal) | Other: Balanced supplement<br>* Balanced supplement 200 mL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in digestive well-being measured after the test meal | Change in average well-being measured by 10 score scales at the end of the test meal. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in satiety measured after the test meal | Change in average satiety measured by 10 score scales at the end of the test meal | 1 day | 
| Change in fullness sensation measured after the test meal | Change in average fullness measured by 10 score scales at the end of the test meal | 1 day | 
| Change in abdominal discomfort/pain sensation measured after the test meal | Change in average abdominal discomfort/pain measured by 10 score scales at the end of the test meal | 1 day | 
| Change in mood measured after the test meal | Change in average mood measured by 10 score scales at the end of the test meal. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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meal ingestion, meal composition, postprandial responses, hedonic sensations, homeostatic sensations