Investigation of the Efficacy and Safety of Three Test Products and Comparator on Muscular Performance After the Initiation of a Resistance Training Program
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Pea Protein Powder Participants will be instructed to mix the IP with 250 mL room temperature water once/day for 12 weeks. |
Other: Test Product 1
Pea Protein powder
|
| Experimental: Pea & Oat Protein Powder Participants will be instructed to mix the IP with 250 mL room temperature water once/day for 12 weeks. |
Other: Test Product 2
Pea & Oat Protein Powder
|
| Experimental: Oat Protein Powder Participants will be instructed to mix the IP with 250 mL room temperature water once/day for 12 weeks. |
Other: Test Product 3
Oat Protein Powder
|
| Active Comparator: Whey Protein Isolate Participants will be instructed to mix the IP with 250 mL room temperature water once/day for 12 weeks. |
Other: Comparator
Whey Protein Isolate
|
Outcome Measures
Primary Outcome Measures
- The difference in composite whole-body muscle strength [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 Outcome Measures
- The difference in change in handgrip strength [From baseline to days 28, 56 and 84]
The difference in change in muscle strength as assessed by handgrip strength from baseline to days 28, 56 and 84 between IPs 1, 2, 3 and comparator
- The difference in change in isometric leg strength [From baseline to days 28, 56 and 84]
The difference in change in muscle strength as assessed by isometric leg strength from baseline to days 28, 56 and 84 between IPs 1, 2, 3 and comparator
- The difference in change in upper body strength [From baseline to days 28, 56 and 84]
The difference in change in muscle strength as assessed by upper body strength from baseline to days 28, 56 and 84 between IPs 1, 2, 3 and comparator
- The difference in change in weight [From baseline to day 84]
The difference in change in body composition: weight from baseline to day 84 between IPs 1, 2, 3 and comparator
- The difference in change in waist circumference [From baseline to day 84]
The difference in change in body composition: waist circumference as assessed by physical measurements from baseline to day 84 between IPs 1, 2, 3 and comparator
- The difference in change in android/gynoid fat ratio [From baseline to day 84]
The difference in change in body composition: android/gynoid fat ratio as assessed by DXA from baseline to day 84 between IPs 1, 2, 3 and comparator
- The difference in change in fat mass (% or g) [From baseline to day 84]
The difference in change in body composition: fat mass (% or g) as assessed by DXA from baseline to day 84 between IPs 1, 2, 3 and comparator
- The difference in change in muscle mass (% or g) [From baseline to day 84]
The difference in change in body composition: muscle mass (% or g) as assessed by DXA from baseline to day 84 between IPs 1, 2, 3 and comparator
- The difference in change in endurance performance [From baseline to days 28, 56 and 84]
The difference in change in endurance performance as assessed by Treadmill Walk Test from baseline to days 28, 56 and 84 between IPs 1, 2, 3 and comparator
- The difference in change in quality of life [From baseline to days 28, 56 and 84]
The difference in change in quality of life as assessed by RAND SF-36 Quality of Life Questionnaire from baseline to days 28, 56 and 84 between IPs 1, 2, 3 and comparator
- The difference in change in blood CRP concentrations [From baseline to days 28, 56 and 84]
The difference in change in blood CRP concentrations from baseline to days 28, 56 and 84 between IPs 1, 2, 3 and comparator
- The difference in change in immune function [From screening to day 84]
The difference in change in immune function as assessed by white blood cell (WBC), lymphocyte and neutrophil counts from screening to day 84 between IPs 1, 2, 3 and comparator
- The difference in change in product tolerability [From baseline to days 28, 56 and 84]
The difference in change in product tolerability as assessed by Modified Gastrointestinal Symptoms Rating Scale (GSRS) from baseline to days 28, 56 and 84 between IPs 1, 2, 3 and comparator
- The difference in product perception [At day 84]
The difference in product perception as assessed by the Product Perception Questionnaire at day 84 between IPs 1, 2, 3 and comparator
Other Outcome Measures
- 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 as assessed by cytokine response in tumour-necrosis factor (TNF)-α from baseline to days 28, 56 and 84 between IPs 1, 2, 3 and comparator
- 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 as assessed by cytokine response in interleukin (IL)-6 from baseline to days 28, 56 and 84 between IPs 1, 2, 3 and comparator
- The difference in change in immune function: cytokine response in IL-10 [From baseline to days 28, 56 and 84]
The difference in change in immune function as assessed by cytokine response in IL-10 from baseline to days 28, 56 and 84 between IPs 1, 2, 3 and comparator
- Munich ChronoType Questionnaire [At baseline]
The difference in Munich ChronoType Questionnaire (MCTQ) at baseline between IPs 1, 2, 3 and comparator
- The difference in change in exercise recovery [At baseline, day 28, 56 and 84]
The difference in change in exercise recovery as assessed by Delayed Onset Muscle Soreness (DOMS) Questionnaire completed 24-, 48-, and 72-hours following the maximum exercise test performed at baseline, day 28, 56 and 84 between IPs 1, 2, 3 and comparator
- Incidence of pre-emergent and post-emergent adverse events [From baseline to day 84]
Incidence of pre-emergent and post-emergent adverse events
- Blood pressure (BP) [At baseline, day 28, 56 and 84]
Systolic and Diastolic
- Heart rate (HR) [At baseline, day 28, 56 and 84]
Heart rate
- Aspartate aminotransferase (AST) [At baseline and 84]
Aspartate aminotransferase (AST)
- Alanine aminotransferase (ALT) [At baseline and 84]
Alanine aminotransferase (ALT)
- Alkaline phosphatase (ALP) [At baseline and 84]
Alkaline phosphatase (ALP)
- Total bilirubin [At baseline and 84]
Total bilirubin
- Creatinine [At baseline and 84]
Creatinine
- Electrolytes (Na, K, Cl) [At baseline and 84]
Electrolytes (Na, K, Cl)
- Glucose [At baseline and 84]
Glucose
- Estimated glomerular filtration rate (eGFR) [At baseline and 84]
Estimated glomerular filtration rate (eGFR)
- Hematology (monocytes, eosinophils, basophils) [At baseline and 84]
Hematology (monocytes, eosinophils, basophils)
- Red blood cell (RBC) count [At baseline and 84]
Red blood cell (RBC) count
- Hemoglobin [At baseline and 84]
Hemoglobin
- Hematocrit [At baseline and 84]
Hematocrit
- Platelet count [At baseline and 84]
Platelet count
- Mean corpuscular volume (MCV) [At baseline and 84]
RBC indices: mean corpuscular volume (MCV)
- Mean corpuscular hemoglobin (MCH) [At baseline and 84]
RBC indices: mean corpuscular hemoglobin (MCH)
- Mean corpuscular hemoglobin concentration (MCHC) [At baseline and 84]
RBC indices: mean corpuscular hemoglobin concentration (MCHC)
- Red cell distribution width (RDW) [At baseline and 84]
RBC indices: red cell distribution width (RDW)
Eligibility Criteria
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
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
-
Agrees to maintain their daily caloric intake
-
Willingness to complete questionnaires, records and diaries associated with the study and to complete all study assessments
-
Willing to refrain from taking NSAID for 24 hours prior to and 72 post study appointments
-
Provided voluntary, written, informed consent to participate in the study
-
Healthy as determined by medical history, laboratory results and electrocardiogram (ECG), as assessed by Qualified Investigator (QI)
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
-
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
-
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 pharmaceutical, weight loss/diet, exercise intervention or clinical research studies 30 days prior to enrollment 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | KGK Science | London | Ontario | Canada | N6A 5R8 |
Sponsors and Collaborators
- Roquette Canada, LTD.
Investigators
- Principal Investigator: David Crowley, MD, KGK Science Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21PMHR