Protein and Satiety in Older Adults (PROSAT)

June 6, 2024 updated by: Miriam Clegg, University of Reading

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High Physically Active Group
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
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.
Other: Normal Milkshake
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.
Experimental: Low Physically Active Group
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
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.
Other: Normal Milkshake
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ad-libitum meal consumption
Time Frame: 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.
2 days in total

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Reading

Collaborators

Ministry of National Education, Turkey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2021

Primary Completion (Actual)

August 23, 2022

Study Completion (Actual)

August 23, 2022

Study Registration Dates

First Submitted

August 11, 2022

First Submitted That Met QC Criteria

August 16, 2022

First Posted (Actual)

August 19, 2022

Study Record Updates

Last Update Posted (Actual)

June 7, 2024

Last Update Submitted That Met QC Criteria

June 6, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UREC 21/40

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No personal identification data will be shared. The study is not under an obligation to share data, however, it is possible that some of the individual (unliked / non-identifiable) data will be useful in a meta-analysis and, hence sharing individual participant data (IPD) will be considered.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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