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The Anabolic Properties of Fortified Plant-based Protein in Older People (Strongplant)

Primary Purpose

Muscle Protein Synthesis, Sarcopenia

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Fortified plant-based protein blend
Plant-based protein blend
Whey protein
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Muscle Protein Synthesis focused on measuring Muscle metabolism, Dietary protein, Plant protein

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: Male sex Aged between 60 and 75 y inclusive BMI between 18.5 and 30 kg/m2 Exclusion Criteria: Vegetarian and vegan diet Intolerant to milk products Soy allergy Pea allergy Participating in a structured (progressive) exercise program or >2.5h of vigorous physical activity per week. Smoking regularly (i.e. >5 cigarettes/week) Diagnosed GI tract disorders or diseases Diagnosed musculoskeletal disorders Diagnosed metabolic disorders (e.g. diabetes) Diagnosed with phenylketonuria (PKU) Hypertension (blood pressure above 140/90 mmHg) Donated blood 3 months prior to test day Use of any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories). Chronic use of gastric acid suppressing medication Chronic use of anti-coagulants Recent (<1 year) participation in amino acid tracer studies (L-[ring-13C6]-phenylalanine and L-[3,5-2H2]-tyrosine)

Sites / Locations

  • Maastricht University Medical Center+Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Fortified plant protein blend

Normal plant protein blend

Whey protein

Arm Description

20g of plant-based protein blend fortified with 2 g leucine

20g of plant-based protein blend

20g of whey protein

Outcomes

Primary Outcome Measures

Postprandial muscle protein fractional synthesic rate
Muscle protein synthesis rates are calculated using L-ring-13C6-phenylalanine tracer and provided as 1 integrated value over the specified timeframe using plasma as precursor.

Secondary Outcome Measures

Postabsorptive ('basal') muscle protein fractional synthesis rate
Muscle protein synthesis rates are calculated using L-ring-13C6-phenylalanine tracer and provided as 1 integrated value over the specified timeframe using plasma as precursor.
Plasma amino acids concentrations
Post-prandial plasma amino acid availability
Plasma glucose concentrations
Post-prandial plasma glucose availability
Plasma insulin concentrations
Post-prandial plasma insulin availability

Full Information

First Posted
January 20, 2023
Last Updated
September 21, 2023
Sponsor
Maastricht University Medical Center
Collaborators
Danone Nutricia
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1. Study Identification

Unique Protocol Identification Number
NCT05711095
Brief Title
The Anabolic Properties of Fortified Plant-based Protein in Older People
Acronym
Strongplant
Official Title
The Effect of Ingesting a Novel Fortified Plant-based Protein Mix on Acute Muscle Protein Synthesis in Older People
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 21, 2023 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Danone Nutricia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Rationale: Consumption of sufficient dietary protein is fundamental to skeletal muscle mass maintenance and overall health. Conventional animal-based protein sources such as meat, poultry, fish, eggs, and dairy are considered high-quality sources of dietary protein. However, the production of sufficient amounts of these conventional animal-based proteins to meet future global food demands will be challenging. Consequently, there is a great interest in more sustainable alternatives for these high-quality protein sources. Plant-derived proteins can be produced on a more sustainable scale, but are generally considered lower quality protein sources compared to animal-based sources because of incomplete essential amino acid profiles, resulting in lower anabolic properties for skeletal muscle building. Blending different plant-derived proteins can be a solution, but will never match the profile of other high-quality animal-derived proteins, likely necessitating the fortification of such plant-based protein blends with essential amino acids such as leucine. Objective: To assess post-prandial muscle protein synthesis rates in older males in response to ingesting a blend of plant protein fortified with free leucine compared to (gold standard) whey protein and compared to the plant protein blend without additional leucine. Study design: randomized, parallel-group, double-blind, combined superiority non-inferiority, intervention trial. Study population: 45 healthy (BMI 18.5-30 kg/m2) older males (age: 60-75 y inclusive). Intervention: Subjects will consume a beverage containing 20g whey protein isolate, 20g of a plant protein blend or the same plant protein blend fortified with 2g leucine. Continuous intravenous stable isotope amino acid tracer infusions will be applied, with plasma and muscle samples collected at different time points throughout the experimental test day. Main study parameters/endpoints: The primary outcome will be postprandial (0-4h) muscle protein synthesis rates following beverage ingestion.
Detailed Description
Aging is accompanied by a loss of skeletal muscle mass and muscle strength. Besides physical activity, the consumption of sufficient dietary protein is fundamental to skeletal muscle mass maintenance and overall health. As older individuals express anabolic resistance to protein intake, it is thought that older people can improve the anabolic response by ingesting higher protein doses. However, ingesting large protein doses is not always feasible. Alternatively, protein quality represents an important factor affecting the anabolic response to food intake. Conventional animal-based protein sources such as meat and dairy are generally considered high-quality sources of dietary protein because they meet all of the indispensable amino acid requirements for humans and are highly digestible. However, the production of sufficient amounts of these conventional animal-based proteins to meet future global food demands represents a massive challenge. Presently, there is a great interest in plant-based proteins as a more sustainable alternative for animal-based proteins. Current data shows that plant-based proteins are generally of a lesser quality when compared to animal-based protein, like whey protein, as evidenced by a lower indispensable amino acid content and deficiencies in one or more specific amino acids (i.e. lysine, leucine and/or methionine). This also translates to a compromised bioavailability and lesser anabolic properties. Studies show that ingestion of a single bolus of a plant protein increases muscle protein synthesis rates to a lesser extent when compared to animal-based proteins. Combining different types of plant-derived proteins to overcome the amino acid deficiencies has been proposed as a strategy to increase the anabolic properties of plant-derived proteins. However, it is not possible to match the amino acid composition to that of the gold standard, whey protein. Another strategy to improve the anabolic properties of plant-derived proteins is fortification with free essential amino acids. Previously, ingestion of 40g of protein as a lysine fortified meat substitute was shown to increase muscle protein synthesis rates to a similar level as the ingestion of chicken. However, it is unclear whether this similarity was caused by the lysine enrichment or by the ingestion of a really high dose of protein that could have maximized muscle protein synthesis rates. Therefore, the principle of fortification is still to be investigated with the ingestion of a much lower (submaximal, but more realistic) dose of 20g protein. Therefore, the aim of the current study is to assess postprandial muscle protein synthesis rates in older males in response to ingestion of a blend of plant protein (20g) fortified with free leucine, as compared to the blend of plant protein without additional leucine, and compared to whey protein as the gold standard. Two primary hypotheses will be tested: it is hypothesized that postprandial muscle protein synthesis rates will be higher following ingestion of the fortified plant protein blend when compared to the normal plant protein blend it is hypothesized that postprandial muscle protein synthesis rates will be at least as high following ingestion of the fortified plant protein blend when compared to whey protein.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Protein Synthesis, Sarcopenia
Keywords
Muscle metabolism, Dietary protein, Plant protein

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, parallel-group, double-blind, combined superiority non-inferiority, intervention trial
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Randomization of interventional drinks will be performed by an independent researcher who will also prepare the drinks on the morning of the test day. Drinks will be prepared in a non-transparent shaker and matched for taste.
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fortified plant protein blend
Arm Type
Experimental
Arm Description
20g of plant-based protein blend fortified with 2 g leucine
Arm Title
Normal plant protein blend
Arm Type
Experimental
Arm Description
20g of plant-based protein blend
Arm Title
Whey protein
Arm Type
Active Comparator
Arm Description
20g of whey protein
Intervention Type
Dietary Supplement
Intervention Name(s)
Fortified plant-based protein blend
Intervention Description
20 grams of protein dissolved in 500 mL water from a non-transparent shaker
Intervention Type
Dietary Supplement
Intervention Name(s)
Plant-based protein blend
Intervention Description
20 grams of protein dissolved in 500 mL water from a non-transparent shaker
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey protein
Intervention Description
20 grams of protein dissolved in 500 mL water from a non-transparent shaker
Primary Outcome Measure Information:
Title
Postprandial muscle protein fractional synthesic rate
Description
Muscle protein synthesis rates are calculated using L-ring-13C6-phenylalanine tracer and provided as 1 integrated value over the specified timeframe using plasma as precursor.
Time Frame
0-4 hours
Secondary Outcome Measure Information:
Title
Postabsorptive ('basal') muscle protein fractional synthesis rate
Description
Muscle protein synthesis rates are calculated using L-ring-13C6-phenylalanine tracer and provided as 1 integrated value over the specified timeframe using plasma as precursor.
Time Frame
-3 - 0 hours
Title
Plasma amino acids concentrations
Description
Post-prandial plasma amino acid availability
Time Frame
0-4 hours
Title
Plasma glucose concentrations
Description
Post-prandial plasma glucose availability
Time Frame
0-4 hours
Title
Plasma insulin concentrations
Description
Post-prandial plasma insulin availability
Time Frame
0-4 hours
Other Pre-specified Outcome Measures:
Title
Age in years
Description
Reported by participants
Time Frame
Baseline
Title
Bodymass in kg
Description
Scale
Time Frame
Baseline
Title
Height in m
Description
Stadiometer
Time Frame
Baseline
Title
BMI in kg/m^2
Description
Calculated from height and body mass
Time Frame
Baseline
Title
Whole body lean mass in kg
Description
DEXA
Time Frame
Baseline
Title
Appendicular lean mass in kg
Description
DEXA
Time Frame
Baseline
Title
Bodyfat percentage
Description
DEXA
Time Frame
Baseline
Title
Dietary macronutrient intake
Description
Assessed by written dietary intake records
Time Frame
2 days prior to experimental trial day
Title
Drink palatability
Description
Assessed by a visual analogue scale (VAS) after drink ingestion. Whether higher scores mean a better or worse outcome depends on the question
Time Frame
On experimental trial day directly after drink ingestion

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male sex Aged between 60 and 75 y inclusive BMI between 18.5 and 30 kg/m2 Exclusion Criteria: Vegetarian and vegan diet Intolerant to milk products Soy allergy Pea allergy Participating in a structured (progressive) exercise program or >2.5h of vigorous physical activity per week. Smoking regularly (i.e. >5 cigarettes/week) Diagnosed GI tract disorders or diseases Diagnosed musculoskeletal disorders Diagnosed metabolic disorders (e.g. diabetes) Diagnosed with phenylketonuria (PKU) Hypertension (blood pressure above 140/90 mmHg) Donated blood 3 months prior to test day Use of any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories). Chronic use of gastric acid suppressing medication Chronic use of anti-coagulants Recent (<1 year) participation in amino acid tracer studies (L-[ring-13C6]-phenylalanine and L-[3,5-2H2]-tyrosine)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Kuin, MD
Phone
0031433881810
Email
lisa.kuin@maastrichtuniversity.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Wesley Hermans, MSc
Phone
0031433881810
Email
w.hermans@maastrichtuniversity.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc van Loon, PhD
Organizational Affiliation
Maastricht University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center+
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229ER
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luc van Loon, PhD
Phone
0031433881810
Email
l.vanloon@maastrichtuniversity.nl
First Name & Middle Initial & Last Name & Degree
Luc van Loon, PhD
First Name & Middle Initial & Last Name & Degree
Lisa Kuin, MD
First Name & Middle Initial & Last Name & Degree
Wesley Hermans, MSc

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Anabolic Properties of Fortified Plant-based Protein in Older People

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