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CTRI Number  CTRI/2023/10/058217 [Registered on: 03/10/2023] Trial Registered Prospectively
Last Modified On: 01/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Blood NAD levels in healthy aging subjects  
Scientific Title of Study   A randomized, double-blind, placebo-controlled clinical study to evaluate the effect of LN22199, nicotinamide ribose (NR) and its combination on blood NAD levels in healthy aging subjects. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
LN/AA/LN22199/23 Version 02, 28-Apr-2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mr Prason Kumar J  
Designation  Overall Trial Coordinator  
Affiliation  Laila Nutraceuticals 
Address  40-15-14, First Floor, R&D Division, Clinical Research Department, Brindavan colony, Labbipet, Vijayawada

Krishna
ANDHRA PRADESH
520010
India 
Phone  08662464445  
Fax  08662475278   
Email  prason@lailanutra.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Golakoti Trimurtulu  
Designation  Senior Vice-president-Technical  
Affiliation  Laila Nutraceuticals 
Address  Ground Floor, R&D Division, Survey No. 181/2,181/3,181/4B, JRD Tata Industrial Estate, Kanur, Vijayawada

Krishna
ANDHRA PRADESH
520007
India 
Phone  08666636666  
Fax  08662546216  
Email  drgt@lailanutra.in  
 
Details of Contact Person
Public Query  
Name  Mr Prason Kumar J  
Designation  Manager-Clinical Research  
Affiliation  Laila Nutraceuticals 
Address  40-15-14,First Floor,R&D Division,Clinical Research Department, Brindavan colony, Labbipet, Vijayawada

Krishna
ANDHRA PRADESH
520010
India 
Phone  08662464445  
Fax  08662475278   
Email  prason@lailanutra.in  
 
Source of Monetary or Material Support  
Laila Nutraceuticals Internal funding, 40-15-14, Brindavan colony, Labbipet, Vijayawada, Krishna,Andhra Pradesh- 520010  
 
Primary Sponsor  
Name  Laila Nutraceuticals  
Address  40-15-14, Brindavan Colony, Labbipet, Vijayawada, Krishna, Andhra Pradesh-520010,India  
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr G Ramesh  Anu Hospitals  Department of gastroenterology, Room No : 01, Ground Floor, Kovelamudivari Street, Suryaraopet, Vijayawada-520002, India.
Krishna
ANDHRA PRADESH 		 08662438881

drctresearch@gmail.com 
Dr Thabish Syed   Latha Super Specialities Hospital  Department of cardiology, Second floor, 29-14-58, Besides SBI Zonal Office, Prakasam Road, Suryaraopet, Vijayawada -520002, India.
Krishna
ANDHRA PRADESH 		 08662498482

syedthabish@gmail.com 
Dr Varun Kumar B  Premier super speciality Hospital- MGAKI  Department of Nephrology, Room No : 02, First floor 54-15-14/2A, Near Novotel hotel, NH-5 Service Rd, Bharathi Nagar, Vijayawada-520008, India,
Krishna
ANDHRA PRADESH 		 08662434849

varun.vims@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethics Committee - Aditya Multi Speciality Hospital for Dr. Varun Kumar. B  Approved 
Institutional Ethics Committee - Anu Hospitals for Dr. G. Ramesh   Approved 
Institutional Ethics Committee- Latha Super Specialities Hospital for Dr. Thabish Syed   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Anti-aging 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  LN22199 500 mg Plus NR 500 mg (1:1) : 1000 mg/day  Two capsules in the morning after breakfast for 60 days. 
Intervention  LN22199 : 1000 mg/day   Two capsules in the morning after breakfast for 60 days. 
Intervention  NR : 500 mg/day  Two capsules in the morning after breakfast for 60 days. 
Comparator Agent  Placebo  Two capsules in the morning after breakfast for 60 days. 
 
Inclusion Criteria  
Age From  55.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
Change from baseline to the end of the study period in:
NAD Metabolites (NAAD, NMN & NR), 1-MeNAM & Nicotinamide in blood  		 Day 1, Day 30 & Day 60  
change from baseline to the end of the study period in:
1-MNA (1-MeNAM), Me-2-Py, Nicotinamide, Methionine & Homocysteine in urine  		 Day 1, Day 30 & Day 60  
change from baseline to the end of the study period in:
NADase activity in isolated peripheral blood mononuclear cell (PBMC)  		 Day 1, Day 30 & Day 60  
change from baseline to the end of the study period in:
Six minute walk test (SMWT)
 		 Day 1, Day 30 & Day 60  
change from baseline to the end of the study period in:
Quality of life questionnaire (SF-36)  		 Day 1, Day 30 & Day 60  
change from baseline to the end of the study period in:
Mini Mental State Examination-2 (SV)  		 Day 1, Day 30 & Day 60  
change from baseline to the end of the study period in:
Newcastle mitochondrial quality of life measure (NMQ)  		 Day 1, Day 30 & Day 60 
change from baseline to the end of the study period in:
GDF-15, NFL, TNF- alpha & IL-6 in serum
 		 Day 1 & Day 60  
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
Final Enrollment numbers achieved (Total)= "140"
Final Enrollment numbers achieved (India)="140" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/10/2023 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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 composition’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.

 
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