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

Muscle Strength Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04814225
• Other study ID #: 21PMHR
• Status: Completed
• Phase: Phase 2
• Start date: April 1, 2021
• Est. completion date: April 18, 2022

Study information

• Verified date: April 2022
• Source: Roquette Canada, LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 18, 2022
• Est. primary completion date: April 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Males & females between 30 and <60 years of age, inclusive

2. Waist circumference < 102 cm (40 inches) in men and < 88 cm (35 inches) in women

3. 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

4. Participant having a sedentary lifestyle defined as not engaging in greater than 60 minutes of regular and structured moderate to vigorous exercise per week

5. 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

6. Agrees to follow and is able to complete the exercise guidelines for the duration of the study

7. Motivated to comply with exercise guidelines as assessed by the Self-Motivation Questionnaire at screening

8. Agrees to avoid vigorous exercise outside of regular routine for 48 hours prior to and after exercise challenge

9. Agrees to maintain their daily caloric intake

10. Willingness to complete questionnaires, records and diaries associated with the study and to complete all study assessments

11. Willing to refrain from taking NSAID for 24 hours prior to and 72 post study appointments

12. Provided voluntary, written, informed consent to participate in the study

13. Healthy as determined by medical history, laboratory results and electrocardiogram (ECG), as assessed by Qualified Investigator (QI)

Exclusion Criteria:

1. Women who are pregnant, breast feeding, or planning to become pregnant during the study

2. Allergy, sensitivity, or intolerance to the investigational product's active or inactive ingredients. Adheres to a vegan diet

3. Engaged in regular and structured resistance training (=2x times per week) as assessed by the QI

4. 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

5. Metal implants that may affect the DEXA scan results as assessed on case-by-case basis by the QI

6. 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

7. Current regular use of a protein supplement unless willing to washout (Section 7.3.2)

8. Current use of over-the-counter medications, dietary supplements, foods/drinks for muscle building or function unless willing to washout (Section 7.3.2)

9. Current use of prescribed medications for muscle building or function (see Section 7.3.1)

10. 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

11. 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.

12. History of kidney stones will be assessed by the QI on a case-by-case basis

13. Self-reported confirmation of a HIV-, Hepatitis B- or C-positive diagnosis, autoimmune disease or those that are immune compromised

14. Self-reported confirmation of blood/bleeding disorders

15. Alcohol intake >2 standard drinks per day

16. 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

17. Participation in other pharmaceutical, weight loss/diet, exercise intervention or clinical research studies 30 days prior to enrollment as assessed by the QI

18. Individuals who are unable to give informed consent

19. 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 Strength

Intervention

Other:
• Test Product 1
Pea Protein powder
• Test Product 2
Pea & Oat Protein Powder
• Test Product 3
Oat Protein Powder
• Comparator
Whey Protein Isolate

Locations

Country	Name	City	State
Canada	KGK Science	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Roquette Canada, LTD.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The difference in change in immune function: cytokine response in (TNF)-a	The difference in change in immune function as assessed by cytokine response in tumour-necrosis factor (TNF)-a from baseline to days 28, 56 and 84 between IPs 1, 2, 3 and comparator	From baseline to days 28, 56 and 84
Other	The difference in change in immune function: cytokine response in IL-6	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	From baseline to days 28, 56 and 84
Other	The difference in change in immune function: cytokine response in IL-10	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	From baseline to days 28, 56 and 84
Other	Munich ChronoType Questionnaire	The difference in Munich ChronoType Questionnaire (MCTQ) at baseline between IPs 1, 2, 3 and comparator	At baseline
Other	The difference in change in exercise recovery	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	At baseline, day 28, 56 and 84
Other	Incidence of pre-emergent and post-emergent adverse events	Incidence of pre-emergent and post-emergent adverse events	From baseline to day 84
Other	Blood pressure (BP)	Systolic and Diastolic	At baseline, day 28, 56 and 84
Other	Heart rate (HR)	Heart rate	At baseline, day 28, 56 and 84
Other	Aspartate aminotransferase (AST)	Aspartate aminotransferase (AST)	At baseline and 84
Other	Alanine aminotransferase (ALT)	Alanine aminotransferase (ALT)	At baseline and 84
Other	Alkaline phosphatase (ALP)	Alkaline phosphatase (ALP)	At baseline and 84
Other	Total bilirubin	Total bilirubin	At baseline and 84
Other	Creatinine	Creatinine	At baseline and 84
Other	Electrolytes (Na, K, Cl)	Electrolytes (Na, K, Cl)	At baseline and 84
Other	Glucose	Glucose	At baseline and 84
Other	Estimated glomerular filtration rate (eGFR)	Estimated glomerular filtration rate (eGFR)	At baseline and 84
Other	Hematology (monocytes, eosinophils, basophils)	Hematology (monocytes, eosinophils, basophils)	At baseline and 84
Other	Red blood cell (RBC) count	Red blood cell (RBC) count	At baseline and 84
Other	Hemoglobin	Hemoglobin	At baseline and 84
Other	Hematocrit	Hematocrit	At baseline and 84
Other	Platelet count	Platelet count	At baseline and 84
Other	Mean corpuscular volume (MCV)	RBC indices: mean corpuscular volume (MCV)	At baseline and 84
Other	Mean corpuscular hemoglobin (MCH)	RBC indices: mean corpuscular hemoglobin (MCH)	At baseline and 84
Other	Mean corpuscular hemoglobin concentration (MCHC)	RBC indices: mean corpuscular hemoglobin concentration (MCHC)	At baseline and 84
Other	Red cell distribution width (RDW)	RBC indices: red cell distribution width (RDW)	At baseline and 84
Primary	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	The difference in change in handgrip strength	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	From baseline to days 28, 56 and 84
Secondary	The difference in change in isometric leg strength	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	From baseline to days 28, 56 and 84
Secondary	The difference in change in upper body strength	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	From baseline to days 28, 56 and 84
Secondary	The difference in change in weight	The difference in change in body composition: weight from baseline to day 84 between IPs 1, 2, 3 and comparator	From baseline to day 84
Secondary	The difference in change in waist circumference	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	From baseline to day 84
Secondary	The difference in change in android/gynoid fat ratio	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	From baseline to day 84
Secondary	The difference in change in fat mass (% or g)	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	From baseline to day 84
Secondary	The difference in change in muscle mass (% or g)	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	From baseline to day 84
Secondary	The difference in change in endurance performance	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	From baseline to days 28, 56 and 84
Secondary	The difference in change in quality of life	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	From baseline to days 28, 56 and 84
Secondary	The difference in change in blood CRP concentrations	The difference in change in blood CRP concentrations from baseline to days 28, 56 and 84 between IPs 1, 2, 3 and comparator	From baseline to days 28, 56 and 84
Secondary	The difference in change in immune function	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	From screening to day 84
Secondary	The difference in change in product tolerability	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	From baseline to days 28, 56 and 84
Secondary	The difference in product perception	The difference in product perception as assessed by the Product Perception Questionnaire at day 84 between IPs 1, 2, 3 and comparator	At day 84