Investigation of the Efficacy and Safety of Three Test Products and Comparator on Muscular Performance After the Initiation of a Resistance Training Program

NCT04814225 | Completed Phase 2

• 1 other identifier: 21PMHR
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this randomized, triple-blind, comparator controlled, parallel clinical trial is to investigate the functional equivalence of three test products compared to whey protein on muscular performance in a healthy, sedentary adult population.

Conditions

Muscle Strength

Keywords

pea protein; oat protein; whey protein

Outcome Measures

Primary Outcomes (1)

• The difference in composite whole-body muscle strength

  The difference in composite whole-body muscle strength, as assessed by the sum of handgrip, elbow flexion and extension and knee flexion and extension strength from baseline to day 84 between IPs 1, 2, 3 and comparator.

  From baseline to day 84

Secondary Outcomes (14)

• The difference in change in handgrip strength

  From baseline to days 28, 56 and 84

• The difference in change in isometric leg strength

  From baseline to days 28, 56 and 84

• The difference in change in upper body strength

  From baseline to days 28, 56 and 84

• The difference in change in weight

  From baseline to day 84

• The difference in change in waist circumference

  From baseline to day 84

Other Outcomes (25)

• The difference in change in immune function: cytokine response in (TNF)-α

  From baseline to days 28, 56 and 84

• The difference in change in immune function: cytokine response in IL-6

  From baseline to days 28, 56 and 84

• The difference in change in immune function: cytokine response in IL-10

  From baseline to days 28, 56 and 84

Study Arms (4)

Pea Protein Powder

EXPERIMENTAL

Participants will be instructed to mix the IP with 250 mL room temperature water once/day for 12 weeks.

Other: Test Product 1

Pea & Oat Protein Powder

EXPERIMENTAL

Participants will be instructed to mix the IP with 250 mL room temperature water once/day for 12 weeks.

Other: Test Product 2

Oat Protein Powder

EXPERIMENTAL

Participants will be instructed to mix the IP with 250 mL room temperature water once/day for 12 weeks.

Other: Test Product 3

Whey Protein Isolate

ACTIVE COMPARATOR

Participants will be instructed to mix the IP with 250 mL room temperature water once/day for 12 weeks.

Other: Comparator

Interventions

Test Product 1 OTHER

Pea Protein powder

Pea Protein Powder

Test Product 2 OTHER

Pea \& Oat Protein Powder

Pea & Oat Protein Powder

Test Product 3 OTHER

Oat Protein Powder

Oat Protein Powder

Comparator OTHER

Whey Protein Isolate

Whey Protein Isolate

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males \& females between 30 and \<60 years of age, inclusive
• Waist circumference \< 102 cm (40 inches) in men and \< 88 cm (35 inches) in women
• Female participant is not of child-bearing potential, defined as females who have undergone a sterilization 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,
• Females of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
• Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
• Double-barrier method
• Intrauterine devices
• Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
• Vasectomy of partner at least 6 months prior to screening
• Participant having a sedentary lifestyle defined as not engaging in greater than 60 minutes of regular and structured moderate to vigorous exercise per week
• 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
• Agrees to follow and is able to complete the exercise guidelines for the duration of the study
• Motivated to comply with exercise guidelines as assessed by the Self-Motivation Questionnaire at screening
• Agrees to avoid vigorous exercise outside of regular routine for 48 hours prior to and after exercise challenge

You may not qualify if:

• Women who are pregnant, breast feeding, or planning to become pregnant during the study
• Allergy, sensitivity, or intolerance to the investigational product's active or inactive ingredients. Adheres to a vegan diet
• Engaged in regular and structured resistance training (≥2x times per week) as assessed by the QI
• Currently experiencing any medical condition that interferes 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 that may affect the DEXA scan results as assessed on case-by-case basis by the QI
• Participants who have followed a specific diet (e.g. ketogenic, paleo, etc.) or have had a change of diet within 30 days of baseline as assessed by the QI
• Current regular use of a protein supplement unless willing to washout (Section 7.3.2)
• Current use of over-the-counter medications, dietary supplements, foods/drinks for muscle building or function unless willing to washout (Section 7.3.2)
• Current use of prescribed medications for muscle building or function (see Section 7.3.1)
• Current use of prescribed steroidal anti-inflammatory medications (see Section 7.3.1), or anti-inflammatory over-the-counter medications or supplements (see Section 7.3.2) unless willing to washout
• Significant cardiovascular event or revascularization in the past 6 months. Participants with history of cardiovascular event or revascularization will be assessed case by case by the QI. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis.
• History of kidney stones will be assessed by the QI on a case-by-case basis
• Self-reported confirmation of a HIV-, Hepatitis B- or C-positive diagnosis, autoimmune disease or those that are immune compromised
• Self-reported confirmation of blood/bleeding disorders
• Alcohol intake \>2 standard drinks per day

Sponsors & Collaborators

• Roquette Canada, LTD.: lead

Study Sites (1)

KGK Science

London, Ontario, N6A 5R8, Canada

Location

Study Officials

• David Crowley, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A randomized, triple-blind, comparator controlled, parallel clinical trial

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 24, 2021
• Study Start: April 1, 2021
• Primary Completion: April 18, 2022
• Study Completion: April 18, 2022
• Last Updated: April 27, 2022

Record last verified: 2022-04

Locations

CA (1)