| CTRI Number |
CTRI/2022/12/048047 [Registered on: 13/12/2022] Trial Registered Prospectively |
| Last Modified On: |
21/07/2023 |
| 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 LN22198 and LN22199 supplementation on blood NAD levels in healthy aging subjects. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LN/AA/LN22198/22 Version 01, 01-Sep-2022 |
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
|
|
|
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 |
Kovelamudivari Street, Suryaraopet,
Vijayawada-520002, India.
Krishna
ANDHRA PRADESH |
91-7893062708
drctresearch@gmail.com |
| Dr M Meena kumari |
Latha Super Specialities Hospital |
29-14-58, Besides SBI Zonal Office,
Prakasam Road, Suryaraopet,
Vijayawada - 520002, India.
Krishna
ANDHRA PRADESH |
91-9985464003
meenamedikonda@gmail.com |
| Dr Y Mounika |
Lifeline Trimurthy Hospital |
D. No.29-19 80, Dornakal Road, Suryaraopeta, Vijayawada, Andhra Pradesh 520002
Krishna
ANDHRA PRADESH |
91-9908967553
drmounikayelisetti@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. Y. Mounika |
Approved |
| Institutional Ethics Committee - Anu Hospitals for Dr. G. Ramesh |
Approved |
| Institutional Ethics Committee- Latha Super Specialities Hospital for Dr. M. Meena kumari |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Anti-aging |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LN22198, 1000mg/day |
Two capsules in the morning after breakfast for 60 days. |
| Intervention |
LN22199, 1000mg/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 cellular Nicotinamide adenine dinucleotide (NAD+) levels |
Day 1, Day 30 and Day 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change from baseline to the end of the study
period in: NAD Metabolites in blood (cellular NAAD and NMN)
|
Day 1, Day 30 and Day 60 |
Change from baseline to the end of the study
period in: 1-MNA (1-MeNAM), Me-2-Py, Methionine and Homocysteine in urine |
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). |
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 serum |
Day 1 and Day 60 |
Change from baseline to the end of the study
period in: Six minute walk test |
Day 1, Day 30 and Day 60 |
Change from baseline to the end of the study
period in: Quality of life questionnaire (SF-36) |
Day 1, Day 30 and Day 60 |
Change from baseline to the end of the study
period in: Mini-Mental State Examination |
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) |
Day 1, Day 30 and Day 60 |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/12/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Suspended |
|
Publication Details
|
NIL |
|
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 LN22198 and LN22199 supplementation on blood NAD levels in healthy aging subjects. A total of 105 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 LN22198 or LN22199 or placebo at 1:1:1 ratio. The participants will be instructed to take two capsules 500 mg each(1000mg/day) in the morning after breakfast for 60 days. The outcome measures include blood cellular Nicotinamide adenine dinucleotide (NAD+) levels, NAD Metabolites in blood (cellular NAAD and NMN), 1-MNA (1-MeNAM), Methionine, Me-2-Py and Homocysteine in urine, CD38 activity in isolated peripheral blood mononuclear cell (PBMC), GDF-15, NFL, TNF- Alpha and IL-6 in serum, Six-minute walk test, Quality of life questionnaire (SF-36), Mini-Mental State Examination, Newcastle mitochondrial quality of life measure (NMQ). Besides, the study will also record the vital signs and adverse events to evaluate the herbal composition’s safety and tolerability. The safety assessment of LN22198 and LN22199 will also include routine laboratory investigations on blood, urine, and clinical chemistry at screening and the final visit of the intervention. |