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

NCT ID: NCT05420142

Last Updated: 2022-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-14

Study Completion Date

2022-07-31

Brief Summary

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

Detailed Description

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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

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Aging Undernutrition Appetite Loss Age-Related Sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Test meal incorporating the study groups innovative plant protein and fibre (variety 3) product.

The standardised test meal was prepared in a single dose using Knorr low sodium chicken stock cubes (9g = 1 stock cube), 65.64g of plant protein and fibre variety 3 (3.09g leucine), 28.6g butter, 5.12g cornflour, and 300ml water. The test meal is consumed in a single sitting in the morning following an overnight fast. Blood samples are acquired at baseline and at set intervals over the subsequent 3-hours to examine the net peripheral amino acid appearance.

Group Type EXPERIMENTAL

Net peripheral AA appearance following ingestion of 3 selected PPF products compared to whey

Intervention Type DIETARY_SUPPLEMENT

The 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.

Test meal incorporating the study groups innovative plant protein and fibre (variety 5) product.

The standardised test meal was prepared in a single dose using Knorr low sodium chicken stock cubes (9g = 1 stock cube), 67.78g of plant protein and fibre variety 3 (3.09g leucine), 27.79g butter, 4.63g cornflour, and 300ml water. The test meal is consumed in a single sitting in the morning following an overnight fast. Blood samples are acquired at baseline and at set intervals over the subsequent 3-hours to examine the net peripheral amino acid appearance.

Group Type EXPERIMENTAL

Net peripheral AA appearance following ingestion of 3 selected PPF products compared to whey

Intervention Type DIETARY_SUPPLEMENT

The 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.

Test meal incorporating the study groups innovative plant protein and fibre (variety 6) product.

The standardised test meal was prepared in a single dose using Knorr low sodium chicken stock cubes (9g = 1 stock cube), 57.66g of plant protein and fibre variety 3 (3.09g leucine), 31.72g butter, 6.62g cornflour, and 300ml water. The test meal is consumed in a single sitting in the morning following an overnight fast. Blood samples are acquired at baseline and at set intervals over the subsequent 3-hours to examine the net peripheral amino acid appearance.

Group Type EXPERIMENTAL

Net peripheral AA appearance following ingestion of 3 selected PPF products compared to whey

Intervention Type DIETARY_SUPPLEMENT

The 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.

Test meal incorporating the control comparator (whey protein isolates), plus 10g of added pea fibre.

The standardised test meal was prepared in a single dose using Knorr low sodium chicken stock cubes (9g = 1 stock cube), 36.59g of unflavoured Optimum Nutrition gold standard 100% whey protein (3.09g leucine), 33.23g butter, 9.09g cornflour, and 300ml water. The test meal is consumed in a single sitting in the morning following an overnight fast. Blood samples are acquired at baseline and at set intervals over the subsequent 3-hours to examine the net peripheral amino acid appearance.

Group Type ACTIVE_COMPARATOR

Net peripheral AA appearance following ingestion of 3 selected PPF products compared to whey

Intervention Type DIETARY_SUPPLEMENT

The 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.

Interventions

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Net peripheral AA appearance following ingestion of 3 selected PPF products compared to whey

The 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

OTHER

Sponsor Role collaborator

University of Padova

OTHER

Sponsor Role collaborator

Fraunhofer Institute for Interfacial Engineering and Biotechnology

OTHER

Sponsor Role collaborator

University College Dublin

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Helen Roche, Prof

Role: PRINCIPAL_INVESTIGATOR

University College Dublin

Katy Horner, Dr

Role: PRINCIPAL_INVESTIGATOR

University College Dublin

Dominique Dardevet, Dr

Role: PRINCIPAL_INVESTIGATOR

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement (INRAE)

Giuseppe De Vito, Prof

Role: PRINCIPAL_INVESTIGATOR

University of Padua Department of Biomedical Science, Neuromuscular Physiology Laboratory

Locations

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University college Dublin

Dublin, Leinster, Ireland

Site Status

University of Padua Department of Biomedical Science, Neuromuscular Physiology Laboratory

Padua, , Italy

Site Status

Countries

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Ireland Italy

Other Identifiers

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APPETITE_AA3.1

Identifier Type: -

Identifier Source: org_study_id

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