NCT04623450

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 28, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2021

Completed
Last Updated

November 12, 2020

Status Verified

November 1, 2020

Enrollment Period

2.1 years

First QC Date

October 28, 2020

Last Update Submit

November 9, 2020

Conditions

Appetitive BehaviorGastric Emptying

Keywords

younger adultsolder adultsappetitesatietymacronutrients

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.

    3 days in total

Secondary Outcomes (3)

  • Ratings of appetite

    3 days in total

  • Gastric Emptying

    3 days in total

  • Ratings of palatability

    3 days in total

Study Arms (3)

High Carbohydrate Meal

EXPERIMENTAL

A smoothie including maltodextrin and low-fat strawberry yoghurt - 289 kcal, 61g carbohydrate, 6.7g protein, 1.9g fat.

Other: Smoothie

High Fat Meal

EXPERIMENTAL

A smoothie including double cream and low-fat strawberry yoghurt - 312 kcal, 13.3g carbohydrate, 7g protein, 25.5g fat.

Other: Smoothie

High Protein Meal

EXPERIMENTAL

A smoothie including whey protein and low-fat strawberry yoghurt - 307 kcal, 13.6g carbohydrate, 57g protein, 2.7g fat.

Other: Smoothie

Interventions

SmoothieOTHER

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

High Carbohydrate MealHigh Fat MealHigh Protein Meal

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • either aged \>65 years or \<40 years
  • healthy

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Reading

Reading, United Kingdom

RECRUITING

Related Publications (8)

  • 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: 24814383BACKGROUND

  • 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. doi: 10.1152/ajpregu.1997.272.1.R243.

    PMID: 9039015BACKGROUND

  • 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.

    PMID: 8475895BACKGROUND

  • 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. doi: 10.1093/ajcn/60.4.476.

    PMID: 7661908BACKGROUND

  • 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.

    PMID: 29704915BACKGROUND

  • 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: 28747330BACKGROUND

  • 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.

    PMID: 28431774BACKGROUND

  • 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.

    PMID: 28112772BACKGROUND

MeSH Terms

Conditions

Appetitive Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Central Study Contacts

Miriam Clegg, BSc, PhD

CONTACT

+44 (0)118 378 8723m.e.clegg@reading.ac.uk

Lisa Methven, BSc, PhD

CONTACT

+44 (0)118 378 8714l.methven@reading.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

October 28, 2020

First Posted

November 10, 2020

Study Start

May 5, 2019

Primary Completion

June 7, 2021

Study Completion

September 9, 2021

Last Updated

November 12, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

No personal identification data will be shared. The study is not under an obligation to share data, however, it is possible that some of the individual (unliked / non-identifiable) data will be useful in a meta-analysis and, hence sharing individual participant data (IPD) will be considered.

Locations

GB(1)