Muscle InjuryNCT05946746
The Effects of PeptiStrong and Exercise to Enhance Muscle Strength in Young Subjects
A study testing PeptiStrong in people with Muscle Injury, run by Nuritas Ltd at 1 site in Canada.
Trial summary
A randomised, double-blind, placebo controlled study to evaluate the effect of PeptiStrong supplementation in conjunction with an exercise program to enhance muscle strength and endurance in young male and female subjects. Read more about this study
- Who is it for?
- Ages 19 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Injury
- What is being tested?
- PeptiStrong
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteCanada
- Study dates
- 9 Aug 2023to 23 May 2024
- 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 19 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males \& females between 19 and 40 years of age
- BMI between 18.5 to 29.9 kg/m2, inclusive
- Females not of childbearing potential, defined as those who have undergone a sterilisation procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening, or, Individuals of child bearing potential must have a negative baseline urine pregnant test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control include:
- Hormonal contraceptives including oral contraception, hormone birth control patch, vaginal contraceptive ring, injectable contraceptives, or hormone implant.
- Double-barrier method Intrauterine devices Non-heterosexual lifestyle or agrees to use contraception if planning to change to heterosexual partner Vasectomy of partner at least 6 months prior to screening Abstinence and agrees to use contraception if planning on becoming sexually active
- Willing and be capable of performing the recommended physical training and exercise regimen (3 x/week) for the duration of the study, as determined by the QI
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- Motivated to comply with exercise guidelines as assessed by the Self-motivation Questionnaire at screening
- Self-reported stable body weight for the past 3 months defined as not having gained or lost more than 5 kg of body weight throughout the 3 months prior to baseline as assessed by the QI.
- Agrees to refrain from taking NSAIDs and alcohol consumption for 24 and 48 hours, respectively, prior to each clinic visit
- Agrees to avoid vigorous exercise (e.g. running, swimming laps, tennis singles, uphill hiking, weight lifting) for 48 hours prior to the exercise challenge.
- Agrees to maintain current lifestyle habits as much as possible throughout the study depending on ability to maintain the following: diet and caloric intake, medications, supplements and sleep
- Willingness to complete questionnaires, records and diaries associated with the study and to complete all study assessments
- Provided voluntary, written, informed consent to participate in the study
- Healthy as determined by medical history, physical examination, ECG, and vital signs, as assessed by the QI
Who cannot join
- Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
- Allergy, sensitivity, or intolerance to the investigational product or placebo ingredients
- Has participated in structured resistance/power exercise training for >3 hours/week in the 6 months prior to baseline, as assessed by the QI
- Currently experiencing any medical condition (e.g., orthopedic injury, surgery, neuromuscular problems, musculoskeletal injury and/or disease) that may interfere with the ability to undergo physical strength testing during the study and/or ability to complete exercise guidelines as assessed by the QI
- Metal implants or other physical characteristics/limitations that may affect DEXA scan results, as assessed by the QI
- Participants who have followed a specific diet (e.g. ketogenic, paleo, high-protein, vegetarian etc) or have had a change of diet within 30 days of baseline as assessed by the QI
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- Have a history of being diagnosed with phenylketonuria or another disease affecting amino acid metabolism (i.e., maple syrup urine disease, etc.)
- Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
- Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
- Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
- Current or history of significant diseases of the gastrointestinal tract, as assessed by the QI
- Current unstable significant psychiatric condition (e.g., clinical depression, eating disorders) and/or sleep disorders, as assessed by the QI
- Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
- Type I or Type II diabetes
- Current unstable diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months
- Current use of any prescribed or over-the-counter medications and/or supplements that may affect muscle mass, muscle strength, or metabolism, as assessed by the QI
- Alcohol intake average ˃2 standard drinks per day as assessed by the QI
- Alcohol or drug abuse within the last 12 months
- Regular use of tobacco, vapes or nicotine products within 6 months of baseline and during the study period, as assessed by the QI
- Blood donation 30 days prior to screening, during the study, or a planned donation within 30 days of the last study appointment as assessed by the QI
- Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
- Individuals who are unable to give informed consent
- Any other condition, chronic disease, or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
Trial locations and contacts
1 site in 1 country.
Canada1 site
KGK Science Inc. 275 Dundas Street, TD Tower A, Suite G02
London, Southwestern Ontario, ON N6B 3L1
About this study
Official title: A Randomised, Double-blind, Placebo Controlled Study to Evaluate the Effect of PeptiStrong Supplementation in Conjunction with an Exercise Program to Enhance Muscle Strength in Young Subjects
A randomised, double-blind, placebo controlled study to evaluate the effect of PeptiStrong supplementation in conjunction with an exercise program to enhance muscle strength and endurance in young male and female subjects.
Read the detailed description
This study aims to further investigate the use of PeptiStrong as a sports supplement by evaluating its efficacy for improving muscle strength in healthy males and females. PeptiStrong will be supplemented as a single oral dose of 2.4g/day into the volunteers' diet for 56 days in conjunction with a predefined whole body exercise programme to be performed 3 times per week. The primary outcome will measure the difference in muscle strength as assessed by one-repetition maximum (1RM) using leg extension from baseline to Day 56 between PeptiStrong and placebo.
Secondary endpoints investigated during the trial will include changes in strength via the leg extension at Day 28 between PeptiStrong and Placebo, strength via bench press 1RM at Days 28 and 56, muscle endurance using 80% of baseline 1RM to failure via bench press and leg extension, number of repetitions on leg extension, muscle size measurements, muscle mass via DEXA scanning, arm, chest, thigh and waist circumference, safety and tolerability via adverse event reporting and vital sign recording. In addition to the measurements described above, volunteers will be asked to fill out a quality of life questionnaire for subjective endpoint analysis and also to record their food intake at predefined intervals during the trial.
- Conditions
- Muscle Injury
- Being tested
- PeptiStrong, Placebo SMCC silicated micro-crystalline cellulose
- Keywords
- Muscle health, Muscle strength, Muscle fatigue, Muscle contraction, Physical endurance, Physical fitness, Musculoskeletal health, Body composition, Dietary supplements, Peptides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PeptiStrongDietary supplement
PeptiStrong is a protein hydrolysate derived from Vicia faba. It is a free-flowing powder, pale yellow in colour. For the purposes of the trial, PeptiStrong will be encapsulated in size '00' hydroxypropyl methylcellulose capsules.
Placebo SMCC silicated micro-crystalline celluloseDietary supplement
Placebo - SMCC silicated microcrystalline cellulose (INCI name: MCC, cellulose gel), For the purposes of the trial, SMCC will be encapsulated in size '00' hydropropyl methylcellulose.
| Study group | Role | What they receive |
|---|---|---|
| PeptiStrong - fava bean hydrolysate preparation | Experimental | PeptiStrong 2.4g/day will be supplemented as 5 capsules (480mg each) taken with approx. 150mL water at breakfast once per day for 56 days Receives: Dietary Supplement: PeptiStrong |
| Silicated micro-crystalline cellulose (SMCC) | Placebo comparator | The placebo 2.4g/day will be supplemented as 5 capsules taken with approx. 150mL water at breakfast once per day for 56 days Receives: Dietary Supplement: Placebo SMCC silicated micro-crystalline cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
randomised, double-blind, placebo controlled study to evaluate the effect of PeptiStrong in conjunction with an exercise program on muscle strength in young males and females.
A randomised, double-blind placebo controlled study to evaluate the effect of PeptiStrong, a fava bean derived protein hydrolysate versus placebo when supplemented in conjunction with an exercise program on muscle strength in young males and females. PeptiStrong or placebo will be orally administered once per day for 56 days. Whole body training programmes will be performed thrice weekly. The difference in muscle strength from a baseline measurement at day 0 (Visit 2) to day 56 (Visit 4) will be measured by a 1RM using a leg extension .
Measured: 56 days supplementation
Secondary outcomes (6)
To assess the effects of PeptStrong in conjunction with exercise
To evaluate the effect of a daily administration of PeptiStrong versus placebo, when consumed over a 56 day period in conjunction with an exercise program three times per week on strength via leg extension 1RM (V2-V3)
Measured: 56 days supplementation
To assess the effects of PeptStrong in conjunction with exercise
To evaluate the effect of a daily administration of PeptiStrong versus placebo, when consumed over a 56 day period in conjunction with an exercise program three times per week on strength via bench press 1RM (V2-V4)
Measured: 56 days supplementation
To assess the effects of PeptStrong in conjunction with exercise
To evaluate the effect of a daily administration of PeptiStrong versus placebo, when consumed over a 56 day period in conjunction with an exercise program three times per week on Muscle endurance using 80% of baseline 1RM to failure via leg and bench press (V2-4)
Measured: 56 days supplementation
To assess the effects of PeptStrong in conjunction with exercise
To evaluate the effect of a daily administration of PeptiStrong versus placebo, when consumed over a 56 day period in conjunction with an exercise program three times per week on number of repetitions on leg extension (V2-4)
Measured: 56 days supplementation
To assess the effects of PeptStrong in conjunction with exercise
To evaluate the effect of a daily administration of PeptiStrong versus placebo, when consumed over a 56 day period in conjunction with an exercise program three times per week on measurement of arm, chest, thigh and waist circumference (V2-4)
Measured: 56 days supplementation
To assess the effects of PeptStrong in conjunction with exercise
To evaluate the effect of a daily administration of PeptiStrong versus placebo, when consumed over a 56 day period in conjunction with an exercise program three times per week on skeletal muscle mass and fat mass using DEXA (V1 and V4)
Measured: 56 days supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start9 Aug 2023
- Primary completion23 Jan 2024
- Study completion23 May 2024
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 Muscle InjuryStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuritas Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946746
- Sponsor's protocol ID
- PN23.002
- Status last verified
- Nov 2024
- First submitted
- 7 Jun 2023
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mohan NM, Khaldi N, Keogh B, Franklyn Miller A. Randomised, double-blind, placebo-controlled study to evaluate the effect on human strength and endurance after resistance training and supplementation of Vicia faba protein hydrolysate compared with placebo. BMJ Nutr Prev Health. 2025 Mar 26;8(1):e001050. doi: 10.1136/bmjnph-2024-001050. eCollection 2025.
PubMed 40771513
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo Controlled Study to Evaluate the Effect of PeptiStrong Supplementation in Conjunction with an Exercise Program to Enhance Muscle Strength in Young Subjects
- ClinicalTrials.gov ID
- NCT05946746
- Acronym / sponsor ID
- PN23.002
- Conditions
- Muscle Injury
- Keywords
- Muscle health, Muscle strength, Muscle fatigue, Muscle contraction, Physical endurance, Physical fitness, Musculoskeletal health, Body composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Nuritas LtdIndustry (pharma, biotech, devices)
- Study start
- 9 Aug 2023 (actual)
- Primary completion
- 23 Jan 2024 (actual)
- Study completion
- 23 May 2024 (actual)
- First posted
- 14 Jul 2023 (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.
A randomised, double-blind, placebo controlled study to evaluate the effect of PeptiStrong supplementation in conjunction with an exercise program to enhance muscle strength and endurance in young male and female subjects.
Detailed description
This study aims to further investigate the use of PeptiStrong as a sports supplement by evaluating its efficacy for improving muscle strength in healthy males and females. PeptiStrong will be supplemented as a single oral dose of 2.4g/day into the volunteers' diet for 56 days in conjunction with a predefined whole body exercise programme to be performed 3 times per week. The primary outcome will measure the difference in muscle strength as assessed by one-repetition maximum (1RM) using leg extension from baseline to Day 56 between PeptiStrong and placebo.
Secondary endpoints investigated during the trial will include changes in strength via the leg extension at Day 28 between PeptiStrong and Placebo, strength via bench press 1RM at Days 28 and 56, muscle endurance using 80% of baseline 1RM to failure via bench press and leg extension, number of repetitions on leg extension, muscle size measurements, muscle mass via DEXA scanning, arm, chest, thigh and waist circumference, safety and tolerability via adverse event reporting and vital sign recording. In addition to the measurements described above, volunteers will be asked to fill out a quality of life questionnaire for subjective endpoint analysis and also to record their food intake at predefined intervals during the trial.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PeptiStrong - fava bean hydrolysate preparation | Experimental | Dietary Supplement: PeptiStrongPeptiStrong 2.4g/day will be supplemented as 5 capsules (480mg each) taken with approx. 150mL water at breakfast once per day for 56 days |
| Silicated micro-crystalline cellulose (SMCC) | Placebo comparator | Dietary Supplement: Placebo SMCC silicated micro-crystalline celluloseThe placebo 2.4g/day will be supplemented as 5 capsules taken with approx. 150mL water at breakfast once per day for 56 days |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Males \& females between 19 and 40 years of age
- BMI between 18.5 to 29.9 kg/m2, inclusive
- Females not of childbearing potential, defined as those who have undergone a sterilisation procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening, or, Individuals of child bearing potential must have a negative baseline urine pregnant test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control include:
- Hormonal contraceptives including oral contraception, hormone birth control patch, vaginal contraceptive ring, injectable contraceptives, or hormone implant.
- Double-barrier method Intrauterine devices Non-heterosexual lifestyle or agrees to use contraception if planning to change to heterosexual partner Vasectomy of partner at least 6 months prior to screening Abstinence and agrees to use contraception if planning on becoming sexually active
Key exclusion criteria (23 listed)
- Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
- Allergy, sensitivity, or intolerance to the investigational product or placebo ingredients
- Has participated in structured resistance/power exercise training for >3 hours/week in the 6 months prior to baseline, as assessed by the QI
- Currently experiencing any medical condition (e.g., orthopedic injury, surgery, neuromuscular problems, musculoskeletal injury and/or disease) that may interfere with the ability to undergo physical strength testing during the study and/or ability to complete exercise guidelines as assessed by the QI
- Metal implants or other physical characteristics/limitations that may affect DEXA scan results, as assessed by the QI
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 |
|---|---|---|
| PeptiStrongPeptiStrong is a protein hydrolysate derived from Vicia faba. It is a free-flowing powder, pale yellow in colour. For the purposes of the trial, PeptiStrong will be encapsulated in size '00' hydroxypropyl methylcellulose capsules. | Dietary supplement | PeptiStrong - fava bean hydrolysate preparation |
| Placebo SMCC silicated micro-crystalline cellulosePlacebo - SMCC silicated microcrystalline cellulose (INCI name: MCC, cellulose gel), For the purposes of the trial, SMCC will be encapsulated in size '00' hydropropyl methylcellulose. | Dietary supplement | Silicated micro-crystalline cellulose (SMCC) |
Primary outcome
randomised, double-blind, placebo controlled study to evaluate the effect of PeptiStrong in conjunction with an exercise program on muscle strength in young males and females.
Time frame: 56 days supplementation
A randomised, double-blind placebo controlled study to evaluate the effect of PeptiStrong, a fava bean derived protein hydrolysate versus placebo when supplemented in conjunction with an exercise program on muscle strength in young males and females. PeptiStrong or placebo will be orally administered once per day for 56 days. Whole body training programmes will be performed thrice weekly. The difference in muscle strength from a baseline measurement at day 0 (Visit 2) to day 56 (Visit 4) will be measured by a 1RM using a leg extension .
6 secondary outcomes
To assess the effects of PeptStrong in conjunction with exercise
Time frame: 56 days supplementation
To assess the effects of PeptStrong in conjunction with exercise
Time frame: 56 days supplementation
To assess the effects of PeptStrong in conjunction with exercise
Time frame: 56 days supplementation
To assess the effects of PeptStrong in conjunction with exercise
Time frame: 56 days supplementation
To assess the effects of PeptStrong in conjunction with exercise
Time frame: 56 days supplementation
To assess the effects of PeptStrong in conjunction with exercise
Time frame: 56 days supplementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Derived from this study: PubMed 40771513Mohan NM, Khaldi N, Keogh B, Franklyn Miller A. Randomised, double-blind, placebo-controlled study to evaluate the effect on human strength and endurance after resistance training and supplementation of Vicia faba protein hydrolysate compared with placebo. BMJ Nutr Prev Health. 2025 Mar 26;8(1):e001050. doi: 10.1136/bmjnph-2024-001050. eCollection 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PeptiStrong in people with Muscle Injury, run by Nuritas Ltd 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 14 inclusion and 23 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: finished, as of the sponsor's last update on 20 Nov 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
randomised, double-blind, placebo controlled study to evaluate the effect of PeptiStrong in conjunction with an exercise program on muscle strength in young males and females. (time frame: 56 days supplementation). 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 NCT05946746, 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 20 Nov 2024.