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Clinical Trials/CTRI/2024/06/068758
CTRI/2024/06/068758
Not yet recruiting
Phase 3

A Prospective, Single Arm, Open-label Clinical Study to Evaluate the Anabolic Efficacy of PRP-02 in Healthy Adults. - Nil

Amway Global Services India (AGSI)0 sites0 target enrollmentTBD
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Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
Amway Global Services India (AGSI)
Status
Not yet recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
Amway Global Services India (AGSI)

Eligibility Criteria

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,

Outcomes

Primary Outcomes

Not specified

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