Protein and Satiety in Older Adults (PROSAT)

NCT05507801 | Completed

• 1 other identifier: UREC 21/40
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Appetitive Behavior; Gastric Emptying; Physical Activity; Energy Intake

Keywords

protein; physical activity; older adults; appetite; energy intake; satiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Ratings of appetite

  2 days in total

• Gastric Emptying

  2 days in total

• Ratings of palatability

  2 days in total

Study Arms (2)

High Physically Active Group

EXPERIMENTAL

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; Other: Normal Milkshake

Low Physically Active Group

EXPERIMENTAL

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; Other: Normal Milkshake

Interventions

High Protein Milkshake 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.

High Physically Active Group; Low Physically Active Group

Normal Milkshake 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.

High Physically Active Group; Low Physically Active Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• healthy
• aged ≥ 65 years

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Reading: lead
• Ministry of National Education, Turkey: collaborator

Study Sites (1)

University of Reading

Reading, United Kingdom

Location

Related Publications (7)

• 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.

  PMID: 24814383 BACKGROUND

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

  BACKGROUND

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

  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.

  PMID: 20711440 BACKGROUND

• 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.

  PMID: 20004080 BACKGROUND

• 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.

  PMID: 12548299 BACKGROUND

• 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.

  PMID: 28747330 BACKGROUND

Related Links

• Healthy eating overview-Maintaining a healthy weight.
• Exercise as you get older.

MeSH Terms

Conditions

Appetitive Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single (Participants)
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 19, 2022
• Study Start: November 19, 2021
• Primary Completion: August 23, 2022
• Study Completion: August 23, 2022
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)