| CTRI Number |
CTRI/2023/11/059982 [Registered on: 17/11/2023] Trial Registered Prospectively |
| Last Modified On: |
11/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
To Investigate the change in oral bioavailability of Nicotinamide Mononucleotide (NMN, 500mg) when 5mg Bioperine is added to NMN 500mg in normal healthy volunteers. |
|
Scientific Title of Study
|
A pilot two arm, two period, cross over, open label, Single-centre, comparative trial to Investigate the change in oral bioavailability of Nicotinamide Mononucleotide (NMN, 500mg) when 5mg Bioperine is added to NMN 500mg in normal healthy volunteers. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PRPL-NMN-03-2023 Version 00 Dated 27 Oct 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr T Shivakumar |
| Designation |
Principal Investigator |
| Affiliation |
TR Super Speciality Hospital |
| Address |
Department of General Medicine, Ground Floor 125-1 Kothanur Dinne Main Road JP Nagar 8th Phase Opposite Aspira Apartment Bengaluru
Bangalore
KARNATAKA
560076
India |
| Phone |
9448071435 |
| Fax |
|
| Email |
trhospital@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Satish G |
| Designation |
Vice President |
| Affiliation |
Sami Sabinsa Group Limited |
| Address |
19 1 & 19 2 I Main II Phase Peenya Industrial Area
Bengaluru
Bangalore
KARNATAKA
560058
India |
| Phone |
08068527777 |
| Fax |
|
| Email |
satish.g@sami-sabinsagroup.com |
|
Details of Contact Person
Public Query
|
| Name |
Satish G |
| Designation |
Vice President |
| Affiliation |
Sami Sabinsa Group Limited |
| Address |
19 1 & 19 2 I Main II Phase Peenya Industrial Area
Bengaluru
KARNATAKA
560058
India |
| Phone |
08068527777 |
| Fax |
|
| Email |
satish.g@sami-sabinsagroup.com |
|
|
Source of Monetary or Material Support
|
| Sami Samibnsa Group Limited
19 1 and 19 2 I Main II Phase Peenya Industrial Area Bengaluru 560058 |
|
|
Primary Sponsor
|
| Name |
Sami-Sabinsa Group Limited |
| Address |
19/1 and 19/2, I Main, II Phase, Peenya Industrial Area
Bangalore |
| Type of Sponsor |
Other [Manufactures and markets phytonutrients, standardized herbal extracts and nutritional supplements.] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr T Shivakumar |
TR Super Speciality Hospital |
Department of General Medicine Ground Floor 125-1 Kothanur Dinne Main Road JP Nagar 8th Phase Opposite Aspira Apartment Bengaluru.
Bangalore
KARNATAKA |
08042657777
trhospital@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACE Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nicotinamide Mononucleotide |
Nicotinamide Mononucleotide (500 mg) capsule on Day-1 and Day-5 with 240ml of water. |
| Intervention |
Nicotinamide Mononucleotide and Bioperine |
Nicotinamide Mononucleotide (500 mg) and Bioperine (5 mg) capsule on Day-1 and Day-5 with 240ml of water. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Male subjects and/or non-pregnant, non-lactating female subjects of childbearing potential and/or female subjects who have attained menopause.
2. Subject of age 18 to 45 years and above with BMI of 18.50 – 30.0 Kg/m2.
3. Subjects with normal vital parameters Blood Pressure (120/80 to 139/89 mmHg), pulse rate (70-100 beats/min) and temperature (97.00F-99.00F) and general clinical examination or those considered not clinically significant as decided by the investigator.
4. Subject who agree not consume coffee, tea, cola, chocolate or any other xanthine containing food or drinks within 3 days prior to start of the study and during the washout period.
5. Subject with no current or recent (within 2 weeks before randomization) treatment with any another investigational product.
6. Negative pregnancy test for females and does not plan to become pregnant during course of the study
|
|
| ExclusionCriteria |
| Details |
1. History of uncontrolled systemic diseases such as cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric and hematological disorders, based on clinical investigator’s judgment.
2. History of chronic alcoholism/ chronic smoking/ drug of abuse.
3. Subjects with hypersensitivity to NMN and BIOPERINE or any of the excipients.
4. Pregnant or lactating female subjects.
5. History of consumption of tobacco containing products within 48 hours prior to the proposed time of dosing.
6. Subjects who are positive for hepatitis B, anti-hepatitis C and Human Immunodeficiency Virus (HIV 1&2).
7. Present or past history of intake of vitamins & mineral supplements, herbal medicines or any prescription drugs other than the drugs already included in patient’s treatment regimen or over the counter (OTC) medicines within 14 days which can potentially alter/interfere / modify the PK parameters of NMN and BIOPERINE or any other medication judged to be clinically significant by the investigator.
8. Subjects who had donated blood/had any other blood loss over 01 unit of blood during the last 01 months before study initiation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the change in bioavailability between two different formulations - NMN Arm (A) vs NMN with Bioperine between Arm (B) |
Day-1 and Day-5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy, safety and tolerability of the above formulations in the study subjects by monitoring the incidence of any adverse events (AEs) |
Screening to Day-5 |
|
|
Target Sample Size
|
Total Sample Size="6"
Sample Size from India="6"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="6" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/11/2023 |
| Date of Study Completion (India) |
29/11/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="10" |
|
Recruitment Status of Trial (Global)
|
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
Modification(s)
|
Nicotinamide Mononucleotide is a derivative of Niacin (Vitamin B3) and is precursor to NAD+ which is essential co enzyme for several biological process involving energy metabolism and DNA repair. The absorption and bioavailability of NMN and its analogues greatly varies from person to person because of PK and PD parameters. The present study is aimed to improve the bioavailability and pharmacodynamic changes in normal healthy volunteers. |