A clinical study to evaluate the the Anabolic Efficacy of PRP-02 in Healthy Human Adults.

Phase 3

• Registration Number: CTRI/2024/06/068758
• Lead Sponsor: Amway Global Services India (AGSI)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Healthy vegetarian, adult male and female subjects, aged 18 to 45 years (both inclusive)

2.Subjects who are not taking any supplements with anabolic agents (muscle building) and/or protein powder in the past 4 weeks.

3.Subjects who have a habitual protein intake of less than or equal to 0.8 g/kg/day based on a food frequency questionnaire

4.Subjects with Body mass index (BMI) between 19-24.9 (kg/m2) with a stable weight over the past 3 months

5.Females of childbearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test at screening

6.Subjects willing to adhere with their routine diet, physical activity, and general lifestyle throughout the study.

7.Subjects who are able to understand the benefits and risks of the study protocol, follow the protocol and come for follow-up visits.

8.Must be willing and able to give informed consent and comply with the study procedures.

Exclusion Criteria

1.Subjects diagnosed with Type 1 and 2 diabetes mellitus

2.Subjects currently on medication/ HRT (Hormone Replacement Therapy)

3.Subjects with musculoskeletal disorders that make it difficult to exercise

4.Women in the reproductive age group not willing to use standard contraceptive measures.

5.Subjects with history of

oEndocrine hypothalamic- pituitary disease, women with PCOS, adrenal disorder, hypothyroidism

oChronic kidney disease,

oRenal stones,

oLiver dysfunction (with elevated enzyme levels),

oEating disorders,

oChronic gastrointestinal disorders

oInflammatory bowel disease (IBD) or celiac disease,

oMetabolic disorders like hypertension, cardiovascular diseases - that might impair the outcomes

oMalignancy which is currently active or in remission for less than five years after last treatment

6.Subjects with unstable weight (± 5 % fluctuation in their body weight for past 3 months at study entry)

7.Subjects who have undergone a surgical procedure within 1 month of signing informed consent and currently participating or has participated in a study with an investigational drug or device

8.Subjects who maybe allergic to soy or wheat or pea.

9.Known HIV or Hepatitis B positive or any other immuno-compromised state

10.Pregnant and lactating women

11.Currently participating or having participated in another clinical trial during the last 30 days prior to screening or are likely to simultaneously participate in another clinical study.

12.Subjects who are doubtful to comply with study procedures for mental, psychological or social reasons.

13.Subjects who are not willing to sign the informed consent and follow the study protocol.

14.Any additional condition(s) that in the Investigators opinion that may interfere with subject treatment, assessment or compliance with the protocol and would warrant exclusion from the study or prevent the subject from completing the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified