Clinical trial NCT05507801: Protein and Satiety in Older Adults (PROSAT)
Official title: The Effect of Protein on Appetite and Food Intake in More and Less Active Older Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appetitive Behavior
Gastric Emptying
Physical Activity
Energy Intake
Keywords: protein
physical activity
older adults
appetite
energy intake
satiety
Lead sponsor: University of Reading
Sponsor class: OTHER
Collaborators: name: Ministry of National Education, Turkey
First posted: 2022-08-19
Enrollment: 38
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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).

Eligibility criteria: 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).

Primary outcomes:
measure: Ad-libitum meal consumption
timeFrame: 2 days in total
Secondary outcomes:
measure: Ratings of appetite
timeFrame: 2 days in total
measure: Gastric Emptying
timeFrame: 2 days in total
measure: Ratings of palatability
timeFrame: 2 days in total
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: University of Reading
Study officials:
References:
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citation: Morell P, Fiszman S. Revisiting the role of protein-induced satiation and satiety. Food Hydrocolloids. 2017 Jul 1;68:199-210.
citation: Timiras PS. Physiological basis of aging and geriatrics, CRC Press. 2022
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citation: 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.
citation: 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.