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CTRI Number  CTRI/2024/04/065369 [Registered on: 08/04/2024] Trial Registered Prospectively
Last Modified On: 15/04/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Comparative Study of Three Urolithin A Formulations  
Scientific Title of Study   A Comparative Pharmacokinetic Profiles of Three Urolithin A Formulations in Healthy Volunteers: A Randomized, Open-label, Single-dose, Parallel-arm Study 
Trial Acronym  NIL 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
MHC/CT/23-24/055 Version: 2.00; Dated, 07 August 2024  Protocol Number 
MHC/CT/23-24/055 Version: 3.00; Dated, 29 January 2025  Protocol Number 
MHC/CT/23-24/055, Version: 1.00; Dated, 01 March 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ramshyam Agarwal 
Designation  Principal Investigator 
Affiliation  Lokmanya Medical Research Centre and Hospital 
Address  Fourth floor OPD No 401 314 B Telco Road Chinchwad

Pune
MAHARASHTRA
411033
India 
Phone  8087282022  
Fax  -  
Email  ramshyam.research@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gayatri Ganu 
Designation  Managing Director 
Affiliation  Mprex Healthcare Pvt. Ltd. 
Address  Fifth-floor, Office Number 501, 514 Crossroads, Bhumkar Square, Wakad

Pune
MAHARASHTRA
411057
India 
Phone  8554912644  
Fax  -  
Email  clinical@mprex.in  
 
Details of Contact Person
Public Query  
Name  Dr Gayatri Ganu 
Designation  Managing Director 
Affiliation  Mprex Healthcare Pvt. Ltd. 
Address  Fifth-floor, Office Number 501, 514 Crossroads, Bhumkar Square, Wakad

Pune
MAHARASHTRA
411057
India 
Phone  8554912644  
Fax  -  
Email  clinical@mprex.in  
 
Source of Monetary or Material Support  
Amazentis SA, Innovation Park, Building C, Ecublens-1024, Switzerland 
 
Primary Sponsor  
Name  Amazentis SA 
Address  EPFL Innovation Park, Bâtiment C 1015 Lausanne, Switzerland. 
Type of Sponsor  Pharmaceutical industry-Global 
 
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 Ramshyam Agarwal  Lokmanya Medical Research Centre and Hospital  Fourth floor OPD No 401 314 B Telco Road Chinchwad,
Pune
MAHARASHTRA 		 8087282022
-
ramshyam.research@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethics Committee Lokmanya Medical Research Centre  Approved 
Institutional Ethics Committee Lokmanya Medical Research Centre  Approved 
Institutional Ethics Committee Lokmanya Medical Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Human Volunteers 
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Formulation A: Mitopure (Urolithin A) soft-gel capsules  Single dose of Mitopure (Urolithin A) two soft-gel capsules of 250 mg delivering total of 500 mg Urolithin A, to be taken with 240 mL water on an empty stomach, oral in overnight fasted participants. 
Intervention  Formulation B: Strawberry Urolithin A Gummy  Single dose of Strawberry (Urolithin A) Gummy, two gummies containing 500 mg Urolithin A, to be taken with 240 mL water on an empty stomach, oral in overnight fasted participants. 
Intervention  Formulation C: Pro Athletes Muscle recovery powder  Pro Athletes Muscle recovery powder, Single dose of half a scoop of the powder containing 500 mg Urolithin A to be taken with 240 mL milk on an empty stomach, oral in overnight fasted participants. 
Intervention  Formulation D : Mitopure - Urolithin A vegan softgel capsule – Commercial formulation   Mitopure - Urolithin A vegan softgel capsule, two vegan soft-gel capsules, each containing 250 mg of Urolithin A for a total dose of 500 mg Urolithin A. The capsules should be taken orally with 240 ± 2 mL of room temperature water on an empty stomach while in a sitting posture, following an overnight fast.  
Intervention  Formulation E : Urolithin A oval vegan softgel capsule  Two oval vegan softgel capsules containing a total of 500 mg of Urolithin A (each softgel delivering 250 mg of Urolithin A). Mode of Administration: Capsules should be taken orally with 240 ± 2 mL of room temperature water on an empty stomach, after an overnight fast 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1.Healthy male and female participants aged between 18 and 45 years (both inclusive); 2.Non-smoker subject or smoker of not more than 5 cigarettes a day; 3.Body Mass Index (BMI) between 18.50-30.00 kg/m2 inclusive; 4.Trial participants in normal health as determined by personal medical history, clinical examination including vital signs, and clinically acceptable results of laboratory examinations (including serological tests), individual values out of the normal range can be accepted if judged clinically non relevant by the Investigator; 5.Normal ECG recording on a 12-lead ECG and/or chest X-ray (PA view) significant at the screening visit or considered not clinically significant (NCS) by investigators; 6.A negative alcohol breath test result at housing; 7.Trial participant able to communicate effectively, provide voluntary written informed consent and available for the entire study duration; 8.Trial participants willing to adhere to the protocol requirements as evidenced by written informed consent approved by the ethics committee; 9.Ability to fast for at least 14.00 hours and consume standard meals; 10.Accept to refrain consuming certain foods and supplements at least two weeks before inclusion; 11.Female participants must have a negative urine pregnancy test prior to housing; 12.Trial participants that can provide adequate evidence of their identity; 13.The participants agree to refrain from consuming dietary supplements that could potentially impact either muscle or mitochondrial function or contain Urolithin A, such as resveratrol, pomegranate and ellagitannins, nicotinamide riboside, whey protein, leucine, iso-leucine, l-carnitine, creatinine, coenzyme Q10, vitamin A, niacin, folic acids, vitamin C, vitamin E and probiotic foods and supplements, during the 2 weeks before inclusion and throughout the study; 14.Females of childbearing potential agree to use appropriate contraceptive measures like non-hormonal intrauterine devices, barrier methods, and spermicidal agents during the study and 07 days after completion of the study; 15.Male agreeing to use appropriate contraceptive measures like the Double Barrier method (Condom), and should not donate sperm, etc. during the study and 07 days after completion of the study. 
 
ExclusionCriteria 
Details  1.Known hypersensitivity to Urolithin A or related product or any component of intervention, presence or history of drug hypersensitivity, allergic disease or lactose intolerance;
2.Any history or presence of clinically significant medical condition, such as, but not limited to, cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic or infectious disease, thyroid disease, adrenal dysfunction, or organic intracranial lesion;
3.Any treatment which could bring about induction or inhibition of the hepatic microsomal enzyme system within one month of starting the study;
4.History or presence of alcoholism or drug abuse;
5.History or presence of gastric and/or duodenal ulceration;
6.History or presence of cancer;
7.Difficulty with donating blood;
8.Use of any prescribed medication (including herbal remedies) during the two weeks before the start of the study or OTC medicinal products (including herbal remedies) during the week before study initiation and throughout the study;
9.Use of medications such as benzodiazepines, anticonvulsants, or barbiturates for one month before the start of the study and throughout the study;
10.Trial participant consumed tobacco/tobacco-containing products, pan or pan masala, gutkha, and masala (containing beetle nut and tobacco) for at least 48.00 hours before initiation of the study and throughout the study;
11.Trial participant consumed caffeine and/or xanthine-containing foods or beverages (i.e., coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) and grapefruit juice and poppy-containing foods for at least 48.00 hours before initiation of the study and throughout the study;
12.Major illness during the 90 days before screening;
13.Participation in a drug research study within 90 days of screening;
14.Positive screening test result for any one or more of the following: HIV, Hepatitis B, Hepatitis C, and VDRL;
15.History or presence of easy bruising or bleeding;
16.Abnormal diet pattern for whatever reason (e.g., low sodium, fasting, and high protein diets) during the four weeks preceding the study;
17.Females of childbearing potential with any one of the following reported and documented on the medical history:
i.Postmenopausal with spontaneous amenorrhea for at least one year, or
ii.Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or
iii.Total hysterectomy and an absence of bleeding for at least 3 months;
iv.Female volunteers who have used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 07 days before dosing;
18.Pregnant women and nursing mothers;
19.Male and females of childbearing potential unwilling to employ appropriate and reliable method of contraception like non-hormonal intrauterine devices, barrier methods, and spermicidal agents, Double Barrier method (Condom) during the study till 07 days after the completion of the study;
20.Male volunteers willing to donate sperm during the study till 07 days after the completion of the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Plasma Pharmacokinetics parameters of all three Urolithin A formulations  Pharmacokinetic blood samples will be collected
at pre-dose [within 45 min before IP
administration] and post-dose at 1h; 4h; 6h; 8h;
12h; 24h; and 72h. (Total 08 Time points). 
 
Secondary Outcome  
Outcome  TimePoints 
1.Screening, pre-dose, and post-dose vital signs.
2.Chest X-ray ((P/A view) at screening.
3.Clinical examination, ECGs, and clinical laboratory testing (hematology, blood chemistry, and urinalysis) at screening and end of the study.
4.Adverse events, serious adverse events throughout the study.
5.Tolerability of the investigational product from administration to end of the study 		 From Screening to end of the study 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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)   17/04/2024 
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="2"
Days="0" 
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   Functional food and food supplements that have been precisely calibrated to deliver bioactive natural ingredients are a desirable way to unlock health benefits to a wider target population, i.e., those unable to derive the benefits of dietary components that impart various health promoting benefits. Amazentis has developed a food supplement and food product that contains MITOPURE (UA) at specific levels after a controlled manufacturing process such as soft-gel capsules, gummies and powder. In the case of MITOPURE, which is a metabolite of a natural product present in food, one can only guarantee precise dosing levels by providing the bio-actives in a specific formulation. Practically, it would not be possible to consume food products and receive the similar benefits of MITOPURE due to (1) seasonality (2) content level and (3) interpersonal variations of metabolism.
This clinical trial aims to comprehensively evaluate and compare the pharmacokinetic profiles of three distinct formulations of Urolithin A in healthy volunteers. Urolithin A, a metabolite derived from ellagic acid in foods, has garnered attention for its potential health benefits, including its association with improved muscle recovery and antioxidant properties. The formulations under investigation include a soft-gel capsule (Mitopure - Formulation A), a gummy variant (Strawberry Urolithin A Gummy - Formulation B), and a powder designed for pro athletes (Pro Athletes Muscle Recovery Powder - Formulation C).
The study adopts a randomized, open-label, single-dose, parallel-arm approach. The primary objective is to elucidate and compare the plasma pharmacokinetic parameters across the three Urolithin A formulations. By employing a rigorous methodology involving pharmacokinetic sampling at predetermined time points, this trial aims to provide detailed insights into the absorption, distribution, metabolism, and excretion of Urolithin A. Safety considerations are paramount, with secondary objectives focusing on assessing the safety and tolerability of the Urolithin A formulations. Adverse events and tolerability will be diligently monitored throughout the study, contributing to a comprehensive safety profile.
This study’s design as an open-label, single-dose, non-randomized trial aligns with the objective of characterizing the concentration-time profiles of Urolithin A formulation in a controlled setting. The inclusion criteria, stringent fasting requirements, standardized fluid intake and strict dietary restriction protocols ensure homogeneity among the study participants, enhancing the reliability of the outcomes.
Ultimately, this clinical trial aims to contribute valuable insights into the pharmacokinetic behavior of different Urolithin A formulations, facilitating informed decisions for future developments and applications in the realm of health and wellness.
 
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