Protein and Satiety in Older Adults (PROSAT)

Not Applicable

Completed

• Conditions: Appetitive Behavior; Gastric Emptying; Physical Activity; Energy Intake
• Interventions: Other: High Protein Milkshake; Other: Normal Milkshake

• Registration Number: NCT05507801
• Lead Sponsor: University of Reading

Brief Summary

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

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).

Study Timeline

• Study Start: 2021-11-19
• Study First Submitted: 2022-08-11
• Study First Submitted QC: 2022-08-16
• Study First Posted: 2022-08-19
• Primary Completion: 2022-08-23
• Study Completion: 2022-08-23
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-06
• Last Update Posted: 2024-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High Physically Active Group	High Protein Milkshake	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.
High Physically Active Group	Normal Milkshake	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.
Low Physically Active Group	High Protein Milkshake	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.
Low Physically Active Group	Normal Milkshake	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.

Primary Outcome Measures

Name	Time	Method
Ad-libitum meal consumption	2 days in total	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Reading; 🇬🇧 Reading, United Kingdom