Nutrition, HealthyPBPNCT05139160
Aminoacidemia and Protein Kinetics in Response to the Ingestion of Plant-based Protein Blends
A study testing Protein quality in people with Nutrition, Healthy, run by McMaster University at 1 site in Canada.
Trial summary
The present investigation aims to study a novel plant based protein isolate blend to determine if it results in similar muscle building responses compared to whey protein isolate. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy
- What is being tested?
- Protein quality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- 15 Aug 2022to 10 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female, between the ages of 18 - 30 years (inclusive)
- Have a body mass index (BMI) between 18-30 kg·m2 (inclusive)
- Be in general good health as assessed by a general health questionnaire
- Non-smoking
- Regular menstrual cycle and not using hormonal contraceptives
- Willing and able to provide informed consent
Who cannot join
- Currently using analgesic or anti-inflammatory drugs
- A history of neuromuscular problems or muscle and/or bone wasting diseases
- Any acute or chronic illness, metabolic disorders
- Currently using corticosteroids
- Use of hormonal contraceptives or anabolic steroids (e.g. testosterone)
Trial locations and contacts
1 site in 1 country.
About this study
The present investigation aims to study a novel plant based protein isolate blend to determine if it results in similar muscle building responses compared to whey protein isolate.
Read the detailed description
Whey protein is considered the 'gold standard' to maintain body proteins (muscle, skin, bone). When isolated from milk, whey protein isolate (WPI) contains all nine essential amino acids (EAA) which are 'building blocks' that are needed to support the maintenance of body proteins. To date, there is no plant-based protein (PBP) isolate that compares to the recommended WPI towards how our body builds or supports our muscles. WPI is considered the 'gold standard' because it contains all of the EAA which provide the right amount of 'building blocks' to support our muscles. Current PBP isolates available contain insufficient amounts of EAA, and are less digestible, resulting in less 'building blocks' available to support our muscles. Recently, plant protein combinations have been designed to provide the right amounts of all the EAAs. Therefore, the aim of the present study is to determine the effects of a novel PBP blend on muscle protein synthesis responses by comparing it to WPI.
- Conditions
- Nutrition, Healthy
- Being tested
- Protein quality
- Keywords
- plant-based protein, whey protein, protein quality, muscle protein synthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein qualityDietary supplement
the present investigation aims to study a novel protein based protein isolate blend with and without leucine an compared with whey protein isolate to determine its impact aminoacidemia and muscle protein synthesis healthy adults.
| Study group | Role | What they receive |
|---|---|---|
| Whey protein isolate | Experimental | Whey protein isolate is the 'gold standard' of protein supplements due to being rich in essential amino acids and leucine. Leucine is a key amino acid the is required to stimulate muscle protein synthesis. Muscle protein synthesis is the major mechanism the underpins muscle growth. The whey protein would ostensibly serve as a positive control. Receives: Dietary Supplement: Protein quality |
| Plant based protein isolate | Experimental | Current plant-based protein isolates available contain insufficient amounts of leucine, and are less digestible, resulting in a reduced muscle protein synthesis responses. The plant based protein would ostensibly serve as a negative control. Receives: Dietary Supplement: Protein quality |
| Plant based protein isolate + leucine | Experimental | Enriching plant-based protein with leucine will increase the 'quality' of said protein source and theoretically should have similar muscle protein synthetic responses to whey protein. Receives: Dietary Supplement: Protein quality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle protein synthesis
A marker of muscle growth
Measured: Over a 5 hour period
Secondary outcomes (5)
Aminoacidemia
Amino acids in the blood
Measured: Over a 5 hour period
Appetite and desire for specific food types in response to test drinks types H
Questionnaire on appetite and palpability of the drinks assessed by a visual analogue scale. 100 mm in length with words anchored at each end, expressing the most positive and the most negative rating used to assess hunger, satiety and fullness. Higher scores mean a better outcome.
Measured: Immediately before, and 30, 60, 120, 180 and 300 minutes after test drinks are consumed.
Palatability of test drinks
Questionnaire of palatability of test drinks assessed by a visual analogue scale. 100 mm in length with words anchored at each end, expressing the most positive and the most negative rating used to assess visual appeal, smell, taste, aftertaste and palatability. Higher scores mean a better outcome.
Measured: Immediately after test drink are consumed.
Questionnaire on safety
Safety will be measured via a questionnaire; e.g. can the participant drink the test drinks and are they okay? Yes or no.
Measured: Over a 5 hour period
Tolerability of test drinks
Tolerability will be measured using Visual Analog Scales anchored by the following descriptors: 0 - no symptoms at all; 100 - worst symptoms participant has ever experienced for the following: nausea, belching, feeling of fullness, vomiting, abdominal distension, flatulence, diarrhoea, dry mouth, and thirst.
Measured: Over a 5 hour period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start15 Aug 2022
- Primary completion1 Apr 2023
- Study completion10 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nutrition, HealthyStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study design will be a randomized, double blind, crossover trial.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stuart Phillips, McMaster University
- Investigators
- Stuart Phillips, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05139160
- Sponsor's protocol ID
- 14040
- Acronym
- PBP
- Status last verified
- Oct 2024
- First submitted
- 9 Nov 2021
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lim C, Janssen TAH, Currier BS, Paramanantharajah N, McKendry J, Abou Sawan S, Phillips SM. Muscle Protein Synthesis in Response to Plant-Based Protein Isolates With and Without Added Leucine Versus Whey Protein in Young Men and Women. Curr Dev Nutr. 2024 May 10;8(6):103769. doi: 10.1016/j.cdnut.2024.103769. eCollection 2024 Jun.
PubMed 38846451
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aminoacidemia and Protein Kinetics in Response to the Ingestion of Plant-based Protein Blends
- ClinicalTrials.gov ID
- NCT05139160
- Acronym / sponsor ID
- PBP / 14040
- Conditions
- Nutrition, Healthy
- Keywords
- plant-based protein, whey protein, protein quality, muscle protein synthesis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 10 Jul 2025 (estimated)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present investigation aims to study a novel plant based protein isolate blend to determine if it results in similar muscle building responses compared to whey protein isolate.
Detailed description
Whey protein is considered the 'gold standard' to maintain body proteins (muscle, skin, bone). When isolated from milk, whey protein isolate (WPI) contains all nine essential amino acids (EAA) which are 'building blocks' that are needed to support the maintenance of body proteins. To date, there is no plant-based protein (PBP) isolate that compares to the recommended WPI towards how our body builds or supports our muscles. WPI is considered the 'gold standard' because it contains all of the EAA which provide the right amount of 'building blocks' to support our muscles. Current PBP isolates available contain insufficient amounts of EAA, and are less digestible, resulting in less 'building blocks' available to support our muscles. Recently, plant protein combinations have been designed to provide the right amounts of all the EAAs. Therefore, the aim of the present study is to determine the effects of a novel PBP blend on muscle protein synthesis responses by comparing it to WPI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- The study design will be a randomized, double blind, crossover trial.
| Arm | Type | Receives |
|---|---|---|
| Whey protein isolate | Experimental | Dietary Supplement: Protein qualityWhey protein isolate is the 'gold standard' of protein supplements due to being rich in essential amino acids and leucine. Leucine is a key amino acid the is required to stimulate muscle protein synthesis. Muscle protein synthesis is the major mechanism the underpins muscle growth. The whey protein would ostensibly serve as a positive control. |
| Plant based protein isolate | Experimental | Dietary Supplement: Protein qualityCurrent plant-based protein isolates available contain insufficient amounts of leucine, and are less digestible, resulting in a reduced muscle protein synthesis responses. The plant based protein would ostensibly serve as a negative control. |
| Plant based protein isolate + leucine | Experimental | Dietary Supplement: Protein qualityEnriching plant-based protein with leucine will increase the 'quality' of said protein source and theoretically should have similar muscle protein synthetic responses to whey protein. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female, between the ages of 18 - 30 years (inclusive)
- Have a body mass index (BMI) between 18-30 kg·m2 (inclusive)
- Be in general good health as assessed by a general health questionnaire
- Non-smoking
- Regular menstrual cycle and not using hormonal contraceptives
Key exclusion criteria (5 listed)
- Currently using analgesic or anti-inflammatory drugs
- A history of neuromuscular problems or muscle and/or bone wasting diseases
- Any acute or chronic illness, metabolic disorders
- Currently using corticosteroids
- Use of hormonal contraceptives or anabolic steroids (e.g. testosterone)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protein qualitythe present investigation aims to study a novel protein based protein isolate blend with and without leucine an compared with whey protein isolate to determine its impact aminoacidemia and muscle protein synthesis healthy adults. | Dietary supplement | Plant based protein isolate, Plant based protein isolate + leucine, Whey protein isolate |
Primary outcome
Muscle protein synthesis
Time frame: Over a 5 hour period
A marker of muscle growth
5 secondary outcomes
Aminoacidemia
Time frame: Over a 5 hour period
Appetite and desire for specific food types in response to test drinks types H
Time frame: Immediately before, and 30, 60, 120, 180 and 300 minutes after test drinks are consumed.
Palatability of test drinks
Time frame: Immediately after test drink are consumed.
Questionnaire on safety
Time frame: Over a 5 hour period
Tolerability of test drinks
Time frame: Over a 5 hour period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Derived from this study: PubMed 38846451Lim C, Janssen TAH, Currier BS, Paramanantharajah N, McKendry J, Abou Sawan S, Phillips SM. Muscle Protein Synthesis in Response to Plant-Based Protein Isolates With and Without Added Leucine Versus Whey Protein in Young Men and Women. Curr Dev Nutr. 2024 May 10;8(6):103769. doi: 10.1016/j.cdnut.2024.103769. eCollection 2024 Jun.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart Phillips, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein quality in people with Nutrition, Healthy, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle protein synthesis (time frame: Over a 5 hour period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05139160, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.