Clinical Trials Directory

Trials / Completed

CompletedNCT05420142

Determination of In-vivo Plasma AA Appearance From Plant Protein Fibre Products

Innovative plAnt Protein Fibre and Physical Activity Solutions to Address Poor appEtite and prevenT undernutrITion in oldEr Adults (APPETITE): Determination of In-vivo Plasma AA Appearance From Plant Protein Fibre Products

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
9 (actual)
Sponsor
University College Dublin · Academic / Other
Sex
All
Age
65 Years
Healthy volunteers
Accepted

Summary

This study aims to assess the digestibility and efficacy of the study groups previously developed innovative plant-based protein and fibre products.

Detailed description

Older people are at high risk of undernutrition, which leads to serious adverse health outcomes, but effective preventive strategies are lacking. Effective, new strategies should focus on the etiology of undernutrition and directly address potential causes and mechanisms underpinning undernutrition. Reduced food intake and restricted dietary diversity are direct consequences of poor appetite. Recent studies have shown, that older persons with a poor appetite demonstrate lower intake of protein and dietary fibre, and of several nutrient-rich food groups (e.g. meat, fish, wholegrains, vegetables), after adjustment for energy intake and other potential confounders, but a higher consumption of food groups low in micronutrients (e.g. fats, oils, sweets, and sodas), compared to those with good appetite. Enhancing dietary protein and fibre intake in older Europeans is a key objective because intake of both nutrients is sub- optimal, not only in those with poor appetite. Adequate protein intake prevents excessive decline in muscle mass and function (sarcopenia), a widespread health-issue in older persons, intensified by undernutrition. Adequate dietary fibre intake prevents constipation and impedes the development of many chronic diseases prevalent in older people. Thus, targeting adequate protein and fibre intake may be particularly beneficial in this vulnerable population. A preparatory short-term study will be performed to assess in 10 healthy older adults the net peripheral Amino Acid (AA) appearance following ingestion of 3 selected Plant-based Proteins and Fibre (PPF) products previously developed by the wider study collaborators, compared to the reference of 30 g whey protein. Plasma concentrations of AA from arterialised blood will be measured by ion exchange chromatography in blood samples (1 drawn before and 6 during 3 hours postprandial). This step will allow the research group to compare in-vitro (previous work) and in-vivo digestibility of several PPF mixtures and identify the product with both optimal amino acid composition and sensory properties as well as optimal post-prandial plasma amino acid profile to be used in further studies.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTNet peripheral AA appearance following ingestion of 3 selected PPF products compared to wheyThe intervention will assess the effects of three difference varieties of plant-based protein and fibre supplements on net peripheral amino acid appearance in blood compared to whey protein with matched fibre content as a control arm.

Timeline

Start date
2022-03-14
Primary completion
2022-05-12
Completion
2022-07-31
First posted
2022-06-15
Last updated
2022-09-26

Locations

2 sites across 2 countries: Ireland, Italy

Source: ClinicalTrials.gov record NCT05420142. Inclusion in this directory is not an endorsement.