Protein and Satiety in Older Adults (PROSAT)

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05507801
• Other study ID #: UREC 21/40
• Status: Recruiting
• Phase: N/A
• Start date: November 19, 2021
• Est. completion date: August 23, 2022

Study information

• Verified date: August 2022
• Source: University of Reading
• Contact: Miriam Clegg, BSc, PhD
• Phone: +44 (0)118 378 8723
• Email: m.e.clegg[@]reading.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: August 23, 2022
• Est. primary completion date: August 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Appetitive Behavior
• Energy Intake
• Gastric Emptying
• Physical Activity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United Kingdom	University of Reading	Reading

Sponsors (2)

Lead Sponsor	Collaborator
University of Reading	Ministry of National Education, Turkey

Country where clinical trial is conducted

United Kingdom, 

References & Publications (7)

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. Review. — View Citation

Deutz NE, Bauer JM, Barazzoni R, Biolo G, Boirie Y, Bosy-Westphal A, Cederholm T, Cruz-Jentoft A, Krznariç 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. — View 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. — View 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. — View Citation

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

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. Review. — View Citation

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

Outcome

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

External Links

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