| CTRI Number |
CTRI/2025/10/096463 [Registered on: 24/10/2025] Trial Registered Prospectively |
| Last Modified On: |
27/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An observational study in adults with obesity to assess the effect and safety of Fast&Up Lean Body (L-Carnitine Tartrate) for weight loss. |
Scientific Title of Study
Modification(s)
|
Prospective observational study to assess the effectiveness and tolerability of L-Carnitine Tartrate in obese adults for weight loss |
| Trial Acronym |
LCARN25 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vivek Redkar |
| Designation |
Director |
| Affiliation |
Redkar Hospital & Research Centre |
| Address |
Medicine Department. Room No. 07, Oxelbag, Dhargal, Pernem
North Goa
GOA
403513
India |
| Phone |
7969792774 |
| Fax |
0231-2991534 |
| Email |
drvivekredkar14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhananjay Lad |
| Designation |
Director |
| Affiliation |
CROM Clinical Research & Medical Tourism Pvt. Ltd. |
| Address |
In front of AYUSH cell, MOPA International Airport Flyover junction, NH-17, Goa-Mumbai Highway, Dhargal, Oxelbag
North Goa
GOA
403513
India |
| Phone |
9158592177 |
| Fax |
0231-2991534 |
| Email |
clinicalresearchgoa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhananjay Lad |
| Designation |
Director |
| Affiliation |
CROM Clinical Research & Medical Tourism Pvt. Ltd. |
| Address |
In front of AYUSH cell, MOPA International Airport Flyover junction, NH-17, Goa-Mumbai Highway, Dhargal, Oxelbag
GOA
403513
India |
| Phone |
9158592177 |
| Fax |
0231-2991534 |
| Email |
clinicalresearchgoa@gmail.com |
|
|
Source of Monetary or Material Support
|
| CROM Clinical Research & Medical Tourism Pvt. Ltd.
In front of AYUSH cell, MOPA International Airport Flyover junction, NH-17, Goa-Mumbai Highway, Dhargal, Oxelbag, North Goa, GOA,403513, India |
|
|
Primary Sponsor
|
| Name |
Fullife Healthcare Pvt. Ltd. |
| Address |
1901 & 1902, 19th floor Lotus grandeur, Veera Desai road ext. Andheri West, Greater
Mumbai, Maharashtra-400053 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Vivek Redkar |
Redkar Hospital & Research Centre |
Medicine Department, Room no. 07, Oxelbag, Dhargal, Pernem
North Goa
GOA |
7969792774
0231-2991534
drvivekredkar14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Redkar Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E668||Other obesity, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Adults aged 21–65 years (men or women)
2.BMI 25–35 kg/m²
3.Newly initiated on Fast&Up Lean Body
4.Willing to follow physician-recommended lifestyle/diet/exercise advice
5.Willing to comply with product intake and follow-up visits
6.Willing to provide informed consent. |
|
| ExclusionCriteria |
| Details |
1.Pregnant or lactating women
2.Known hypersensitivity to L-Carnitine Tartrate or excipients
3.Severe hepatic dysfunction, severe renal impairment, or hypertension
4.Obesity due to hormonal conditions (e.g., hypothyroidism, PCOS, T2DM)
5.Use of weight-reducing supplements/medications, hormonal therapy, pre/pro/synbiotics, multivitamins, antacids, antibiotics, steroids, laxatives within last 2 months
6.Participation in another interventional clinical trial for weight loss
7.Current or recent (within 3 months) treatment diet |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean absolute and percent change in body weight from baseline to follow-up (measured using digital weighing scale) |
Baseline to follow-up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Change in BMI, waist-hip ratio, waist and hip circumference
2.Lean body mass, visceral fat, body fat %, skeletal muscle %, bone mass, metabolism, protein %, obesity degree %, body age (via BIA – Omron Karada Scan)
3.RAND 36-Item Health Survey 1.0 Questionnaire (SF-36) at baseline, week 4, week 8
4.Patient global satisfaction (0–3 scale) at week 8
5.Physician global satisfaction (0–3 scale) at week 8
6.Adherence and discontinuation
7.Adverse event reporting. |
Baseline to follow-up |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/11/2025 |
| 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="2"
Days="0" |
|
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
|
This is a single-centre, prospective, observational study designed to evaluate the effectiveness and tolerability of Fast&Up Lean Body (L-Carnitine Tartrate 1000 mg) in obese adults with a BMI between 25–35 kg/m².
Participants will receive 2 effervescent tablets (2000 mg L-Carnitine Tartrate) daily, dissolved in water and taken 30 minutes before physical activity, for 8 weeks.
The primary outcome is the mean absolute and percent change in body weight from baseline to follow-up visits.
The secondary outcomes include changes in BMI, waist–hip ratio, waist and hip circumference, lean body mass, visceral fat, body fat %, skeletal muscle %, metabolic parameters (assessed using bioelectrical impedance analysis), quality of life (RAND SF-36 questionnaire), patient and physician global satisfaction, treatment adherence, and adverse events.
A total of 50 participants will be enrolled at one site. Data will be analyzed using descriptive statistics, chi-square tests for categorical variables, and ANOVA for continuous variables.
The study will be conducted in compliance with the Declaration of Helsinki, ICH-GCP, Indian GCP, and ICMR guidelines. Written informed consent will be obtained from all participants. |