Protein and Satiety in Older Adults (PROSAT)

Study Overview
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Brief Summary
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This study aims to assess the effect of protein on appetite, food intake and gastric emptying in older adults (≥ 65 years) that are more and less active.

Detailed Description
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To investigate the differences in food intake in older adults that are more or less active and assess any differential responses to protein intake. To compare the effect of meals with high or low protein level but equal in energy and volume on appetite and gastric emptying in older adults that are more or less active (≥ 65 years).

Official Title
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The Effect of Protein on Appetite and Food Intake in More and Less Active Older Adults.

Conditions
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Appetitive Behavior, Gastric Emptying, Physical Activity, Energy Intake

Intervention / Treatment
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* Other: High Protein Milkshake
* Other: Normal Milkshake


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy aged ≥ 65 years Exclusion Criteria: having diabetes or disability or any disease that are likely to influence physical activity or appetite. having an allergy to any of the test foods; disliking or cannot eat any of the test foods; being obese (BMI > 30 kg/m2); taking medications known to influence appetite, food intake or body weight in the past three months; being on a weight loss diet; smoking more than 10 cigarettes a day; not meeting the cut-off point criteria based on the accelerometer data (108.25 ≤ min/per day of moderate and vigorous activity for women or 162 ≥ min/per day moderate and vigorous activity for women and 100.1 ≤ min/per day of moderate and vigorous activity for men or 133.25 ≥ min/per day moderate and vigorous activity for men).

Ages Eligible for Study
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Minimum Age: 65 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 Physically Active Group<br>Based on accelerometer data, women with 162 ≥ min/per day moderate and vigorous activity or men 133.25 ≥ min/per day moderate and vigorous activity. | Other: High Protein Milkshake<br>* A milkshake with high protein level; including whey protein, fat free strawberry yogurt and whole milk - 337 kcal, 27 g carbohydrate, 57 g protein, 16 g fat.<br>Other: Normal Milkshake<br>* A milkshake with normal protein level; including nesquik (strawberry), fat free strawberry yogurt, whole milk, double cream, whey protein and sweetener - 331 kcal, 64 g carbohydrate, 17 g protein, 19 g fat.<br>|
| Experimental: Low Physically Active Group<br>Based on accelerometer data, women with 108.25 ≤ min/per day moderate and vigorous activity or men 100.1 ≤ min/per day moderate and vigorous activity. | Other: High Protein Milkshake<br>* A milkshake with high protein level; including whey protein, fat free strawberry yogurt and whole milk - 337 kcal, 27 g carbohydrate, 57 g protein, 16 g fat.<br>Other: Normal Milkshake<br>* A milkshake with normal protein level; including nesquik (strawberry), fat free strawberry yogurt, whole milk, double cream, whey protein and sweetener - 331 kcal, 64 g carbohydrate, 17 g protein, 19 g fat.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ad-libitum meal consumption | Consumption of the ad-libitum meal is measured (g). Participants are instructed to eat until they feel comfortable full and are given 20 min to consume the meal. | 2 days in total | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratings of appetite | Appetite are assessed using a 100 mm Visual Analogue Scales (VAS, scale 0-100). | 2 days in total | 
| Gastric Emptying | Gastric emptying is measured using of 100 microliters of 13C Octanoic Acid breath test | 2 days in total | 
| Ratings of palatability | Palatability ratings are assessed using a 100 mm Visual Analogue Scales (VAS, scale 0-100). | 2 days in total | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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protein, physical activity, older adults, appetite, energy intake, satiety