None listed
Conditions
Interventions
Intervention1: FEFLG oral capsules: 300 mg, oral
One capsule, once a day,
12 Weeks of Treatment Duration
Control Intervention1: Placebo: 300 mg, oral
One capsule, once a day,
12 Weeks of Treatment
Sponsors
Indus Biotech Limited
Innvocept Global Solutions Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female participant between chronological age of 45 to 70 (both inclusive) years and Levineâ??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
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 investigatorâ??s opinion makes the participant unsuitable for inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy outcome will be the whole blood Measurement of NAD+ levels by ELISA or LCMS or bothTimepoint: Baseline Week 6 Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Phenotypic age calculation using Levines Phenotypic Age calculator in correlation with levels of albumin creatinine glucose CRP lymphocytes percent mean cell volume red blood cell distribution width alkaline phosphatase & white blood cells count. ATP Measurement by ELISA or LCMS or both. Quality of life as measured by validated SF36 questionnaire. Physical fatigue as measured by validated Fatigue severity scale. Aerobic capacity as measured by 6 minute walk test & treadmill stress test. Leg strength as measured by 30 second chair stand test. Measurement of organ function Heart blood pressure Pulse rate 2D Echo & treadmill stress test Lungs Respiratory rate & Spirometry (forced vital capacity (FVC) forced expiratory volume in one second (FEV1) & FEV1 or FVC ratio) Liver liver function test (AST ALT AST or ALT ratio ALP Albumin Bilirubin) Kidney Serum Creatinine & BUN Pancreas fasting insulin & glucose (HOMA IR) Skin Qualitative assessment Brain Mini Cog©Timepoint: Screening Week 6 Week 12 | — |
Countries
India
Contacts
Public ContactDr Manish Rajak
INDUS BIOTECH LIMITED
Outcome results
None listed