Macronutrients and Satiety in Older and Younger Adults (MACROSAT)

November 9, 2020 updated by: Miriam Clegg, University of Reading

The Effect of Different Macronutrients on Appetite and Satiety in Older and Younger Adults

This study aims to compare the effect of meals high in protein, fat and carbohydrate but equal in energy and volume on energy intake, perceived appetite and gastric emptying in younger (<40 years) and older (> 65 years) people living in the United Kingdom (UK).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

To assess if increasing protein intake in older adults will have a compensatory decrease in energy intake due to protein's satiating effects.

To compare the effect of meals high in protein, fat and carbohydrate but equal in energy and volume on energy intake and perceived appetite in younger (<40 years) and older adults (>65 years).

To compare the effect of meals high in protein, fat and carbohydrate but equal in energy and volume on gastric emptying in younger (<40 years) and older adults (>65 years).

Study Type

Interventional

Enrollment (Anticipated)

40

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • either aged >65 years or <40 years
  • healthy

Exclusion Criteria:

  • having a disease and/or using a medication that can impact on appetite in the past three months;
  • having an allergy to any of the test foods;
  • disliking or cannot eat any of the test foods;
  • being pregnant or breastfeeding;
  • being obese (BMI > 30 kg/m2);
  • being on a weight loss diet;
  • smoking more than 10 cigarettes a day.

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 Carbohydrate Meal
A smoothie including maltodextrin and low-fat strawberry yoghurt - 289 kcal, 61g carbohydrate, 6.7g protein, 1.9g fat.
Other: Smoothie
Preload smoothies that are matched for taste, smell, appearance, quantity and calorie but different caloric content.
Experimental: High Fat Meal
A smoothie including double cream and low-fat strawberry yoghurt - 312 kcal, 13.3g carbohydrate, 7g protein, 25.5g fat.
Other: Smoothie
Preload smoothies that are matched for taste, smell, appearance, quantity and calorie but different caloric content.
Experimental: High Protein Meal
A smoothie including whey protein and low-fat strawberry yoghurt - 307 kcal, 13.6g carbohydrate, 57g protein, 2.7g fat.
Other: Smoothie
Preload smoothies that are matched for taste, smell, appearance, quantity and calorie but different caloric content.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ad-libitum meal consumption
Time Frame: 3 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.
3 days in total

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ratings of appetite
Time Frame: 3 days in total
Appetite are assessed using a 100 mm Visual Analogue Scales (VAS, scale 0-100).
3 days in total
Gastric Emptying
Time Frame: 3 days in total
Gastric emptying is measured using of 13C octanoic acid breath test
3 days in total
Ratings of palatability
Time Frame: 3 days in total
Palatability ratings are assessed using a 100 mm Visual Analogue Scales (VAS, scale 0-100).
3 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

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)

May 5, 2019

Primary Completion (Anticipated)

June 7, 2021

Study Completion (Anticipated)

September 9, 2021

Study Registration Dates

First Submitted

October 28, 2020

First Submitted That Met QC Criteria

November 9, 2020

First Posted (Actual)

November 10, 2020

Study Record Updates

Last Update Posted (Actual)

November 12, 2020

Last Update Submitted That Met QC Criteria

November 9, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UREC 19/25

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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