NCT05420142

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2022

Shorter than P25 for phase_2

Geographic Reach
2 countries

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 14, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2022

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 15, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

September 26, 2022

Status Verified

September 1, 2022

Enrollment Period

2 months

First QC Date

May 4, 2022

Last Update Submit

September 23, 2022

Conditions

AgingUndernutritionAppetite LossAge-Related Sarcopenia

Keywords

Amino AcidGut hormonesOlder adultsSuccessful ageingPlant proteinFibre

Outcome Measures

Primary Outcomes (1)

  • Acute change in amino acid appearance in peripheral blood following a test meal ingestion

    Arterialised blood samples will be drawn from antecubital vein and centrifuged at 4˚C for 10 minutes at 4000rpm and frozen at -80˚C until analysed. Samples will be analysed using HPLC methods and expressed in μmol/L.

    Blood samples will be taken at baseline, and at 30, 60, 90, 120, 150, & 180 minutes following ingestion of test sample

Secondary Outcomes (2)

  • Acute changes in appetite and desire to eat

    baseline, 30, 60, 90, 120, 150, & 180 minutes following ingestion of a sample meal

  • Sensory properties and palatability of the test meal after ingestion

    Immediately following test meal ingestion (single measure)

Study Arms (4)

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

EXPERIMENTAL

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.

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

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

EXPERIMENTAL

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.

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

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

EXPERIMENTAL

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.

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

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

ACTIVE COMPARATOR

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.

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

Interventions

Net peripheral AA appearance following ingestion of 3 selected PPF products compared to wheyDIETARY_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.Test meal incorporating the study groups innovative plant protein and fibre (variety 3) product.Test meal incorporating the study groups innovative plant protein and fibre (variety 5) product.Test meal incorporating the study groups innovative plant protein and fibre (variety 6) product.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University college Dublin

Dublin, Leinster, Ireland

Location

University of Padua Department of Biomedical Science, Neuromuscular Physiology Laboratory

Padua, 35131, Italy

Location

MeSH Terms

Conditions

MalnutritionAnorexia

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Helen Roche, Prof

    University College Dublin

    PRINCIPAL INVESTIGATOR

  • Katy Horner, Dr

    University College Dublin

    PRINCIPAL INVESTIGATOR

  • Dominique Dardevet, Dr

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

    PRINCIPAL INVESTIGATOR

  • Giuseppe De Vito, Prof

    University of Padua Department of Biomedical Science, Neuromuscular Physiology Laboratory

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2022

First Posted

June 15, 2022

Study Start

March 14, 2022

Primary Completion

May 12, 2022

Study Completion

July 31, 2022

Last Updated

September 26, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)IE(1)