A Randomized, Triple-blind, Comparator Controlled, Parallel Clinical Trial to Study the Efficacy and Safety of Three Test Products and Comparator on Muscular Performance in a Healthy, Sedentary Adult Population After the Initiation of a Resistance Training Program
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Muscle Strength
- Sponsor
- Roquette Canada, LTD.
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- The difference in composite whole-body muscle strength
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Detailed Description
Whey, a by-product of cheese manufacturing, is commonly used as an ingredient in meat products, dairy products, baked goods, snacks, beverages, and infant formula. Its widespread use is due to its advantageous effects on health, economics, and high nutritional value by containing lactose, minerals, vitamins, and soluble proteins. Due to allergies, dietary restrictions and/or personal dietary choices there is a need for an alternative protein source(s), and plant-based protein options are in demand for these reasons. Roquette produces the NUTRALYS® Pea Protein family of ingredients, supplying the widest range of pea protein ingredients to the food industry suitable for use in a plethora of plant-based foods. Few studies have examined the equivalence between pea protein and whey on muscle performance in sedentary adults. 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
The difference in composite whole-body muscle strength
Time Frame: From baseline to day 84
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.
Secondary Outcomes
- The difference in change in weight(From baseline to day 84)
- The difference in change in android/gynoid fat ratio(From baseline to day 84)
- The difference in change in product tolerability(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 fat mass (% or g)(From baseline to day 84)
- 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 waist circumference(From baseline to day 84)
- The difference in change in muscle mass (% or g)(From baseline to day 84)
- The difference in change in quality of life(From baseline to days 28, 56 and 84)
- The difference in change in blood CRP concentrations(From baseline to days 28, 56 and 84)
- The difference in change in immune function(From screening to day 84)
- The difference in product perception(At day 84)
- The difference in change in endurance performance(From baseline to days 28, 56 and 84)