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CTRI Number  CTRI/2025/07/092027 [Registered on: 30/07/2025] Trial Registered Prospectively
Last Modified On: 30/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Crossover Trial 
Public Title of Study   A Clinical Study to Compare How Regular NAD+ and a New Liposomal NAD+ (LNAD+) Are Absorbed in Healthy Adults"  
Scientific Title of Study   A Prospective, Single-Centre, Two-Arm, Interventional, Randomized, Double-Blind, Cross-Over Study to Evaluate and Compare the Pharmacokinetics of NAD+ and its Liposomal Formulation (LNAD+) in Healthy Adult Participants. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
EP_NAD_003_25 Final Version 01 dated 09 Jun 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Chikkalingaiah Siddegowda 
Designation  Consultant 
Affiliation  Medstar Speciality Hospital 
Address  opd room 1 research department, 2nd floor Kodigehalli Main Rd, Shanthivana, Sahakarnagar, Bangalore

Bangalore
KARNATAKA
560092
India 
Phone  9884457106  
Fax    
Email  drchikkalingaiahmedstar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Chikkalingaiah Siddegowda 
Designation  Consultant 
Affiliation  Medstar Speciality Hospital 
Address  opd room 1 research department, 2nd floor Kodigehalli Main Rd, Shanthivana, Sahakarnagar, Bangalore


KARNATAKA
560092
India 
Phone  9884457106  
Fax    
Email  drchikkalingaiahmedstar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Chikkalingaiah Siddegowda 
Designation  Consultant 
Affiliation  Medstar Speciality Hospital 
Address  opd room 1 research department, 2nd floor Kodigehalli Main Rd, Shanthivana, Sahakarnagar, Bangalore


KARNATAKA
560092
India 
Phone  9884457106  
Fax    
Email  drchikkalingaiahmedstar@gmail.com  
 
Source of Monetary or Material Support  
Medstar Speciality Hospital  
 
Primary Sponsor  
Name  Medstar Specialist Hospital 
Address  opd room 1 research department 2 floor Kodigehalli Main Rd, Shanthivana, Sahakarnagar, Bengaluru, Karnataka 560092.  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Chikkalingaiah Siddegowda  Medstar Speciality Hospital  opd room 1 research department 2 floor Medstar Specialist Hospital, Kodigehalli Main Rd, Shanthivana, Sahakarnagar, Bengaluru, Karnataka 560092.
Bangalore
KARNATAKA 		 9884457106

drchikkalingaiahmedstar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Medstar Speciality Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Ageing 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  LNAD+  Formulation- Capsules Route of Administration- Oral A total of four capsules will be administered as a single dose after breakfast. Duration -10 days LNAD+ Arm: Each capsule contains 500 mg, with the active ingredient (NAD+) comprising 50% of the formulation. Each person in the arm will take 4 LNAD+ capsules orally (a total of 2000 mg of LNAD+ (equivalent to 1000 mg of NAD+) 
Intervention  NAD+  Formulation- Capsules Route of Administration- Oral A total of four capsules will be administered as a single dose after breakfast. Duration -10 days NAD+ Arm: Each capsule contains 250 mg. Each person in the arm will take 4 NAD+ capsules orally (a total of 1000 mg of NAD+).  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Adult male/female healthy participants aged 18 to 65 years;

2. Participants with Body Mass Index (BMI) between 18.5 and 24.99 kg/m2;

3. Participants who are willing to provide written Informed Consent for participating in the study;

4. Participants who are able to follow verbal and written study directions;

5. Participants willing to abstain from consumption of foods, medications, or dietary supplements containing the investigational drug (or related compounds) from 3 days prior the start of the study and throughout its duration. 
 
ExclusionCriteria 
Details  1. Participants with history of allergic reactions or hypersensitivity to the investigational drug or related supplements;

2. Participants having abnormal screening laboratory test values or other lab test result(s) that would preclude study participation in the judgment of the investigator;

3. Participants with any acute illness diagnosed within 3 months before screening;

4. Participants with a medical history or active diagnosis of chronic diseases or conditions affecting the urinary, cardiovascular, neuroendocrine (including diabetes), immune, central nervous, hematopoietic, gastrointestinal, hepatic, or visual systems, hereditary diseases, or other significant systemic disorders, as well as those with acute infectious diseases within 28 days prior to the study, known allergies or positive test results for sexually transmitted infections such as HIV, hepatitis B, hepatitis C, or syphilis;

5. Female participants with positive result for urinary beta human chorionic gonadotropin or gestation period or breastfeeding;

6. Participants who smoked more than 2 cigarettes a day within 6 months before screening

7. Participants unwilling to refrain from high intensity physical activity for a minimum of 3 days before start of the study and throughout its duration.

8.Participants who have a history of recent injuries or is hospitalized within the past 3 months 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
NAD+ concentrations will be assessed by determining the following:
· Whole blood concentration
· Plasma concentration
· Erythrocyte concentration 		 Time frame: 0h, 0.5h, 1.0h, 1.5h, 2.0h, 3.0h, 4.0h, 6.0h, 8.0h, 12.0h, and 24.0h 
 
Secondary Outcome  
Outcome  TimePoints 
Pharmacokinetic parameters will be assessed by determining the following: · Peak Plasma Concentration (Cmax) · Time to peak drug concentration (Tmax), Area under curve (AUC) and half life  Time frame: 0h, 0.5h, 1.0h, 1.5h, 2.0h, 3.0h, 4.0h, 6.0h, 8.0h, 12.0h, and 24.0h 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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   Phase 2 
Date of First Enrollment (India)   20/08/2025 
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="0"
Days="10" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

This study is designed to fill that void. Using a randomized, double-blind, crossover design, the trial will compare the pharmacokinetics of orally administered native NAD and its liposomal formulation LNAD in healthy adults. By measuring parameters across both formulations, the study aims to:

· Quantify systemic exposure of NAD from both formulations,

· Evaluate whether liposomal encapsulation significantly enhances oral bioavailability, and

· Determine interindividual variability in pharmacokinetic response.

 
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