Safety, Efficacy, and Bioavailability of PS2 in Different Doses A Pilot Study

A Prospective, Randomized, Double-Blind, Parallel-Group Study to Evaluate the Safety, Efficacy, and Bioavailability of PS2 in Physical Performance. - Nil

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/02/080585

Enrollment

Registered

2025-02-14

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: PS2: 1g orally once a day for 7 days Intervention2: PS2: 3g orally once a day for 7 days Intervention3: PS2: 5g orally once a day for 7 days Control Intervention1: Placebo: 5g orally on

Eligibility

Inclusion criteria

Inclusion criteria: 1.BMI between 18.5 and 29.9 kg/m 2.Non-smokers and non-alcoholic participants 3.Engaged in moderate physical activity 4.Willing to maintain their habitual diet and exercise routine during the study period 5.Able to provide informed consent and comply with the study protocol.

Exclusion criteria

Exclusion criteria: 1.History of cardiovascular, metabolic, renal, or gastrointestinal disorders 2.Use of medications affecting nitric oxide metabolism 3.Recent use of nitrate-rich dietary supplements 4.Regular use of antibacterial mouthwash (as it affects nitrate metabolism) 5.Pregnancy or lactation 6.Allergic to PS2 or any supplement components

Design outcomes

Primary

Measure	Time frame
Evaluate the effect of PS2 in Physical PerformanceTimepoint: Baseline and Day 7	—

Secondary

Measure	Time frame
Assess the bioavailability markers after the acute supplementation of PS2 in different dosesTimepoint: Day 1;Safety ParametersTimepoint: Baseline and Day 7	—

Countries

India

Contacts

Public ContactJestin V Thomas

Leads Clinical Research and Bio Services Pvt. Ltd

jestin.leadsclinbio@gmail.com9845125293

Outcome results