Clinical trial NCT05420142: Determination of In-vivo Plasma AA Appearance From Plant Protein Fibre Products
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Aging
Undernutrition
Appetite Loss
Age-Related Sarcopenia
Keywords: Amino Acid
Gut hormones
Older adults
Successful ageing
Plant protein
Fibre
Lead sponsor: University College Dublin
Sponsor class: OTHER
Collaborators: name: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
name: University of Padova
name: Fraunhofer Institute for Interfacial Engineering and Biotechnology
First posted: 2022-06-15
Enrollment: 9
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Community-dwelling, Age 65+ years, not a heavy smoker (≤10/day), BMI 18-30 kg/m2

Exclusion Criteria:

* Medical condition or medication known to impact appetite or energy intake, consumes more than 14 (female) or 21 (male) units of alcohol per week, inability to come to study centre, self-reported cognitive impairment or diagnosis of clinical depression, heavy smoker (\>10/day)

Primary outcomes:
measure: Acute change in amino acid appearance in peripheral blood following a test meal ingestion
timeFrame: Blood samples will be taken at baseline, and at 30, 60, 90, 120, 150, & 180 minutes following ingestion of test sample
Secondary outcomes:
measure: Acute changes in appetite and desire to eat
timeFrame: baseline, 30, 60, 90, 120, 150, & 180 minutes following ingestion of a sample meal
measure: Sensory properties and palatability of the test meal after ingestion
timeFrame: Immediately following test meal ingestion (single measure)
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: University college Dublin
state: Leinster
city: Padova
country: Italy
facility: University of Padua Department of Biomedical Science, Neuromuscular Physiology Laboratory
Study officials:
affiliation: University College Dublin
name: Helen Roche, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University College Dublin
name: Katy Horner, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement (INRAE)
name: Dominique Dardevet, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Padua Department of Biomedical Science, Neuromuscular Physiology Laboratory
name: Giuseppe De Vito, Prof
role: PRINCIPAL_INVESTIGATOR
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