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

Muscle Injury Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05946746
• Other study ID #: PN23.002
• Status: Recruiting
• Phase: N/A
• Start date: August 9, 2023
• Est. completion date: May 23, 2024

Study information

• Verified date: March 2024
• Source: Nuritas Ltd
• Contact: Niamh Mohan, PhD
• Phone: +35314301290
• Email: mohan.niamh[@]nuritas.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: May 23, 2024
• Est. primary completion date: January 23, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 40 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Muscle Injury

Intervention

Dietary Supplement:
• PeptiStrong
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 cellulose
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.

Locations

Country	Name	City	State
Canada	KGK Science Inc. 275 Dundas Street, TD Tower A, Suite G02	London	Southwestern Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Nuritas Ltd

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	effect of PeptiStrong in conjunction with exercise on future exploratory endpoints including blood biomarkers of muscle homeostasis pre and post exercise	To evaluate the effect of a daily administration of PeptiStrong versus placebo, when supplemented over 56 days in conjunction with a whole body exercise program on blood biomarker interleukin-6 (IL-6).	56 days supplementation
Other	effect of PeptiStrong in conjunction with exercise on future exploratory endpoints including blood biomarkers of muscle homeostasis pre and post exercise	To evaluate the effect of a daily administration of PeptiStrong versus placebo, when supplemented over 56 days in conjunction with a whole body exercise program on blood biomarker lactate dehydrogenase (LDH).	56 days supplementation
Other	effect of PeptiStrong in conjunction with exercise on future exploratory endpoints including blood biomarkers of muscle homeostasis pre and post exercise	To evaluate the effect of a daily administration of PeptiStrong versus placebo, when supplemented over 56 days in conjunction with a whole body exercise program on blood biomarker C-reactive protein (CRP).	56 days supplementation
Other	effect of PeptiStrong in conjunction with exercise on future exploratory endpoints including blood biomarkers of muscle homeostasis pre and post exercise	To evaluate the effect of a daily administration of PeptiStrong versus placebo, when supplemented over 56 days in conjunction with a whole body exercise program on blood biomarker Creatine Kinase (CK)	56 days supplementation
Other	effect of PeptiStrong in conjunction with exercise on future exploratory endpoints including blood biomarkers of muscle homeostasis pre and post exercise	To evaluate the effect of a daily administration of PeptiStrong versus placebo, when supplemented over 56 days in conjunction with a whole body exercise program on blood biomarker tumour necrosis factor (TNFa)	56 days supplementation
Other	effect of PeptiStrong in conjunction with exercise on future exploratory endpoints including blood biomarkers of muscle homeostasis pre and post exercise	To evaluate the effect of a daily administration of PeptiStrong versus placebo, when supplemented over 56 days in conjunction with a whole body exercise program on blood biomarker acylcarnitine.	56 days supplementation
Other	effect of PeptiStrong in conjunction with exercise on future exploratory endpoints including blood biomarkers of muscle homeostasis pre and post exercise	To evaluate the effect of a daily administration of PeptiStrong versus placebo, when supplemented over 56 days in conjunction with a whole body exercise program on free fatty acids (FFA).	56 days supplementation
Other	effect of PeptiStrong in conjunction with exercise on future exploratory endpoints including blood biomarkers of muscle homeostasis pre and post exercise	To evaluate the effect of a daily administration of PeptiStrong versus placebo, when supplemented over 56 days in conjunction with a whole body exercise program on blood biomarker nicotinamide adenine dinucleotide (NAD+).	56 days supplementation
Primary	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	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)	56 days supplementation
Secondary	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)	56 days supplementation
Secondary	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)	56 days supplementation
Secondary	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)	56 days supplementation
Secondary	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)	56 days supplementation
Secondary	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)	56 days supplementation