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

NCT ID: NCT04814225

Last Updated: 2022-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2022-04-18

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.

Conditions

Muscle Strength

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Pea Protein Powder

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

Group Type: EXPERIMENTAL

Test Product 1

Intervention Type: OTHER

Pea Protein powder

Pea & Oat Protein Powder

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

Group Type: EXPERIMENTAL

Test Product 2

Intervention Type: OTHER

Pea \& Oat Protein Powder

Oat Protein Powder

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

Group Type: EXPERIMENTAL

Test Product 3

Intervention Type: OTHER

Oat Protein Powder

Whey Protein Isolate

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

Group Type: ACTIVE_COMPARATOR

Comparator

Intervention Type: OTHER

Whey Protein Isolate

Interventions

Test Product 1

Pea Protein powder

Intervention Type: OTHER

Test Product 2

Pea \& Oat Protein Powder

Intervention Type: OTHER

Test Product 3

Oat Protein Powder

Intervention Type: OTHER

Comparator

Whey Protein Isolate

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Roquette Canada, LTD.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Crowley, MD

Role: PRINCIPAL_INVESTIGATOR

KGK Science Inc.

Locations

KGK Science

London, Ontario, Canada

Countries

Canada

Other Identifiers

21PMHR

Identifier Type: -

Identifier Source: org_study_id