Blood NAD levels in healthy aging subjects

Completed

Brief Summary: The purpose of this study is to evaluate the effect of LN22199, NR and its combination on blood NAD levels in healthy aging subjects. A total of 140 male and female subjects of age between 55 and 70 years will be included in the study. Assessment of inclusion and exclusion criteria will be done based on clinical and laboratory investigations. The eligible subjects will be randomized as per the computer-generated randomization list. The subjects will be assigned to either LN22199 or NR or (LN22199 + NR) or placebo at 1:1:1:1 ratio. The participants will be instructed to take two capsules in the morning after breakfast for 60 days. The outcome measures include Blood Nicotinamide adenine dinucleotide (NAD+) levels, NAD Metabolites (NAAD, NMN & NR), 1-MeNAM and Nicotinamide in blood, 1-MNA (1-MeNAM), Me-2-Py, Nicotinamide, Methionine and Homocysteine in urine, NADase activity in isolated peripheral blood mononuclear cell (PBMC), Six minute walk test (SMWT), Quality of life questionnaire (SF-36), Mini Mental State Examination-2 (SV), Newcastle mitochondrial quality of life measure, GDF-15, NFL, TNF- alpha and IL-6 in serum. Besides, the study will also record the vital signs and adverse events to evaluate the herbal compositionâ€™s safety and tolerability. The safety assessment includes routine laboratory investigations on blood, urine, and clinical chemistry at screening and the final visit of the intervention.

Recruitment & Eligibility

Inclusion Criteria

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.
Subjects considered as healthy by principal investigator through medical history and laboratory results during screening.
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.
Subjects agree not to change their normal daily routine and diet.
Subjects agree to refrain from caffeine consumption on days when study visits included blood collection for metabolite measurement.
Subjects ready to discontinue the use of supplementations including herbal extracts that may affect the study outcome.
Subjects voluntarily agree to participate, sign written informed consent and comply with study protocol.

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.

Primary Outcome Measures

Name	Time	Method
Change from baseline to the end of the study period in: Blood Nicotinamide adenine dinucleotide (NAD+) levels	Day 1, Day 30 & Day 60

Secondary Outcome Measures

Name	Time	Method
Change from baseline to the end of the study period in:	NAD Metabolites (NAAD, NMN & NR), 1-MeNAM & Nicotinamide in blood
change from baseline to the end of the study period in:	1-MNA (1-MeNAM), Me-2-Py, Nicotinamide, Methionine & Homocysteine in urine
change from baseline to the end of the study period in:	GDF-15, NFL, TNF- alpha & IL-6 in serum

Locations (3): Anu Hospitals
🇮🇳
Krishna, ANDHRA PRADESH, India
Latha Super Specialities Hospital
🇮🇳
Krishna, ANDHRA PRADESH, India
Premier super speciality Hospital- MGAKI
🇮🇳
Krishna, ANDHRA PRADESH, India
Anu Hospitals
🇮🇳Krishna, ANDHRA PRADESH, India
Dr G Ramesh
Principal investigator
08662438881
drctresearch@gmail.com