None listed
Conditions
Interventions
Intervention1: LN22198, 1000mg/day: Two capsules in the morning after breakfast for 60 days.
Intervention2: LN22199, 1000mg/day: Two capsules in the morning after breakfast for 60 days.
Control Interv
Sponsors
Laila Nutraceuticals
Eligibility
Inclusion criteria
Inclusion criteria: 1. Ambulatory, male and female subjects of age between 55 and 70 years with a Body Mass Index (BMI) of 24 to 29.9 kg/m2. 2. Subjects considered as healthy by principal investigator through medical history and laboratory results during screening. 3. Subjects ready to avoid taking vitamin B3 (Niacin, Nicotinic acid or niacinamide) or multivitamins two weeks prior to randomization and for the entire duration of the study period. 4. Subjects agree not to change their normal daily routine and diet. 5. Subjects agree to refrain from caffeine consumption on days when study visits included blood collection for metabolite measurement. 6. Subjects ready to discontinue the use of supplementations including herbal extracts that may affect the study outcome. 7. Subjects voluntarily agree to participate, sign written informed consent and comply with study protocol.
Exclusion criteria
Exclusion criteria: 1. Subjects underwent treatment for COVID-19 within last 3 months or tested positive during the study will be excluded. 2. Expectation of any surgery during the study period. 3. Subjects with fasting glucose levels ( >126 mg/dL) and blood pressure (Systolic > 140 mmHg and Diastolic >90 mmHg). 4. Subjects with history of renal or liver impairment, any endocrine, inflammatory, cardiovascular, gastro-intestinal, neurological, psychiatric, neoplastic or metabolic disease. 5. Subjects suffering from COPD or having history of any respiratory or breathing disorders. 6. Subjects with HIV Positive status. 7. Alcohol intake >2 standard drinks per day or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) and smokers. 8. Subjects with history of pellagra or niacin deficiency. 9. Participation in any other trials involving investigational or marketed products within 30 days prior to the screening visit. 10. Clinically significant or abnormal laboratory results during screening. 11. Allergies to any of the study ingredient in the investigational products. 12. Any other condition that, in the opinion of the investigator, would adversely affect the subjects ability to complete the study or its measures or which may pose significant risk to the participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to the end of the study period in: Blood cellular Nicotinamide adenine dinucleotide (NAD+) levelsTimepoint: Day 1, Day 30 and Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to the end of the study period in: 1-MNA (1-MeNAM), Me-2-Py, Methionine and Homocysteine in urineTimepoint: Day 1, Day 30 and Day 60;Change from baseline to the end of the study period in: CD38 activity in isolated peripheral blood mononuclear cell (PBMC).Timepoint: Day 1, Day 30 and Day 60;Change from baseline to the end of the study period in: GDF-15, NFL, TNF- Alpha and IL-6 in serumTimepoint: Day 1 and Day 60;Change from baseline to the end of the study period in: Mini-Mental State ExaminationTimepoint: Day 1, Day 30 and Day 60;Change from baseline to the end of the study period in: NAD Metabolites in blood (cellular NAAD and NMN) Timepoint: Day 1, Day 30 and Day 60;Change from baseline to the end of the study period in: Newcastle mitochondrial quality of life measure (NMQ)Timepoint: Day 1, Day 30 and Day 60;Change from baseline to the end of the study period in: Quality of life questionnaire (SF-36)Timepoint: Day 1, Day 30 and Day 60;Change from baseline to the end of the study period in: Six minute walk testTimepoint: Day 1, Day 30 and Day 60 | — |
Countries
India
Contacts
Public ContactMr Prason Kumar J
Laila Nutraceuticals
Outcome results
None listed