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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04623450
Other study ID # UREC 19/25
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 5, 2019
Est. completion date September 9, 2021

Study information

Verified date November 2020
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
Health authority
Study type Interventional

Clinical Trial Summary

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).


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date September 9, 2021
Est. primary completion date June 7, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Smoothie
Preload smoothies that are matched for taste, smell, appearance, quantity and calorie but different caloric content.

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 (8)

Appleton KM. Limited compensation at the following meal for protein and energy intake at a lunch meal in healthy free-living older adults. Clin Nutr. 2018 Jun;37(3):970-977. doi: 10.1016/j.clnu.2017.03.032. Epub 2017 Apr 7. — View Citation

Beelen J, de Roos NM, de Groot LC. Protein Enrichment of Familiar Foods as an Innovative Strategy to Increase Protein Intake in Institutionalized Elderly. J Nutr Health Aging. 2017;21(2):173-179. doi: 10.1007/s12603-016-0733-y. — View Citation

Blundell JE, Burley VJ, Cotton JR, Lawton CL. Dietary fat and the control of energy intake: evaluating the effects of fat on meal size and postmeal satiety. Am J Clin Nutr. 1993 May;57(5 Suppl):772S-777S; discussion 777S-778S. doi: 10.1093/ajcn/57.5.772S. — View Citation

Clarkston WK, Pantano MM, Morley JE, Horowitz M, Littlefield JM, Burton FR. Evidence for the anorexia of aging: gastrointestinal transit and hunger in healthy elderly vs. young adults. Am J Physiol. 1997 Jan;272(1 Pt 2):R243-8. — View Citation

Clegg ME, Williams EA. Optimizing nutrition in older people. Maturitas. 2018 Jun;112:34-38. doi: 10.1016/j.maturitas.2018.04.001. Epub 2018 Apr 4. 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

Rolls BJ, Kim-Harris S, Fischman MW, Foltin RW, Moran TH, Stoner SA. Satiety after preloads with different amounts of fat and carbohydrate: implications for obesity. Am J Clin Nutr. 1994 Oct;60(4):476-87. — View Citation

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