Protein and Satiety in Older Adults (PROSAT)

NCT ID: NCT05507801

Last Updated: 2024-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-19

Study Completion Date

2022-08-23

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).

Conditions

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Appetitive Behavior Gastric Emptying Physical Activity Energy Intake

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
Single (Participants)

Study Groups

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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.

Group Type EXPERIMENTAL

High Protein Milkshake

Intervention Type OTHER

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.

Normal Milkshake

Intervention Type OTHER

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.

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.

Group Type EXPERIMENTAL

High Protein Milkshake

Intervention Type OTHER

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.

Normal Milkshake

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

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).
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ministry of National Education, Turkey

OTHER_GOV

Sponsor Role collaborator

University of Reading

OTHER

Sponsor Role lead

Responsible Party

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Miriam Clegg

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Reading

Reading, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Deutz NE, Bauer JM, Barazzoni R, Biolo G, Boirie Y, Bosy-Westphal A, Cederholm T, Cruz-Jentoft A, Krznaric Z, Nair KS, Singer P, Teta D, Tipton K, Calder PC. Protein intake and exercise for optimal muscle function with aging: recommendations from the ESPEN Expert Group. Clin Nutr. 2014 Dec;33(6):929-36. doi: 10.1016/j.clnu.2014.04.007. Epub 2014 Apr 24.

Reference Type BACKGROUND
PMID: 24814383 (View on PubMed)

Morell P, Fiszman S. Revisiting the role of protein-induced satiation and satiety. Food Hydrocolloids. 2017 Jul 1;68:199-210.

Reference Type BACKGROUND

Timiras PS. Physiological basis of aging and geriatrics, CRC Press. 2022

Reference Type BACKGROUND

Ahmed T, Haboubi N. Assessment and management of nutrition in older people and its importance to health. Clin Interv Aging. 2010 Aug 9;5:207-16. doi: 10.2147/cia.s9664.

Reference Type BACKGROUND
PMID: 20711440 (View on PubMed)

St-Onge MP, Gallagher D. Body composition changes with aging: the cause or the result of alterations in metabolic rate and macronutrient oxidation? Nutrition. 2010 Feb;26(2):152-5. doi: 10.1016/j.nut.2009.07.004. Epub 2009 Dec 8.

Reference Type BACKGROUND
PMID: 20004080 (View on PubMed)

Margetts BM, Thompson RL, Elia M, Jackson AA. Prevalence of risk of undernutrition is associated with poor health status in older people in the UK. Eur J Clin Nutr. 2003 Jan;57(1):69-74. doi: 10.1038/sj.ejcn.1601499.

Reference Type BACKGROUND
PMID: 12548299 (View on PubMed)

Giezenaar C, Trahair LG, Luscombe-Marsh ND, Hausken T, Standfield S, Jones KL, Lange K, Horowitz M, Chapman I, Soenen S. Effects of randomized whey-protein loads on energy intake, appetite, gastric emptying, and plasma gut-hormone concentrations in older men and women. Am J Clin Nutr. 2017 Sep;106(3):865-877. doi: 10.3945/ajcn.117.154377. Epub 2017 Jul 26.

Reference Type BACKGROUND
PMID: 28747330 (View on PubMed)

Related Links

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Other Identifiers

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UREC 21/40

Identifier Type: -

Identifier Source: org_study_id

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