The Effects of PeptiStrong and Exercise to Enhance Muscle Strength in Young Subjects

NCT05946746 | Completed

• 1 other identifier: PN23.002
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Muscle Injury

Keywords

Muscle health; Muscle strength; Muscle fatigue; Muscle contraction; Physical endurance; Physical fitness; Musculoskeletal health; Body composition; Dietary supplements; Peptides

Outcome Measures

Primary Outcomes (1)

• 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 .

  56 days supplementation

Secondary Outcomes (6)

• To assess the effects of PeptStrong in conjunction with exercise

  56 days supplementation

• To assess the effects of PeptStrong in conjunction with exercise

  56 days supplementation

• To assess the effects of PeptStrong in conjunction with exercise

  56 days supplementation

• To assess the effects of PeptStrong in conjunction with exercise

  56 days supplementation

• To assess the effects of PeptStrong in conjunction with exercise

  56 days supplementation

Other Outcomes (8)

• effect of PeptiStrong in conjunction with exercise on future exploratory endpoints including blood biomarkers of muscle homeostasis pre and post exercise

  56 days supplementation

• effect of PeptiStrong in conjunction with exercise on future exploratory endpoints including blood biomarkers of muscle homeostasis pre and post exercise

  56 days supplementation

• effect of PeptiStrong in conjunction with exercise on future exploratory endpoints including blood biomarkers of muscle homeostasis pre and post exercise

  56 days supplementation

Study Arms (2)

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

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

Dietary Supplement: Placebo SMCC silicated micro-crystalline cellulose

Interventions

PeptiStrong DIETARY_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.

PeptiStrong - fava bean hydrolysate preparation

Placebo SMCC silicated micro-crystalline cellulose DIETARY_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.

Silicated micro-crystalline cellulose (SMCC)

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Nuritas Ltd: lead

Study Sites (1)

KGK Science Inc. 275 Dundas Street, TD Tower A, Suite G02

London, Southwestern Ontario, ON N6B 3L1, Canada

Location

Related Publications (1)

• 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.

  PMID: 40771513 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Double blind
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: July 14, 2023
• Study Start: August 9, 2023
• Primary Completion: January 23, 2024
• Study Completion: May 23, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)