MedPath

A prospective randomized double blind placebo controlled parallel arm clinical study for Healthy Aging

Phase 2
Registration Number
CTRI/2023/07/055305
Lead Sponsor
Indus Biotech Limited
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1. Male and female participant between chronological age of 45 to 70 (both inclusive) years and Levine’s phenotypic age equal to or above chronological age

2. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial

3. Willing to maintain the current diet and exercise during the study period

Exclusion Criteria

1. Pregnant women, women who are breastfeeding, or women who intend to fall pregnant

2. History of significant allergies, allergy, or sensitivity to any of the ingredients in active or placebo formula

3. Participant that have participated in any other clinical trial during the past 3 months

4. Any kind of substance abuse (alcohol, tobacco or any other substance)

5. Participant with clinically significant abnormal laboratory results or uncontrolled disease who are cognitively impaired and or who are unable to give informed consent

6. Intake of supplements containing fenugreek

7. Any condition in the investigator’s opinion makes the participant unsuitable for inclusion

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The primary efficacy outcome will be the whole blood Measurement of NAD+ levels by ELISA or LCMS or bothTimepoint: Baseline <br/ ><br>Week 6 <br/ ><br>Week 12
Secondary Outcome Measures
NameTimeMethod
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