| CTRI Number |
CTRI/2024/12/078448 [Registered on: 23/12/2024] Trial Registered Prospectively |
| Last Modified On: |
21/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Clinical study to see if the supplement HT099 can help overweight adults reduce body fat and improve cholesterol and other blood fat levels. |
|
Scientific Title of Study
|
A Double Blind, Placebo-Controlled, Randomized, Parallel-Group Clinical Trial to
Investigate the Effectiveness of HT099 Intake on Body Fat Composition and Blood Lipid Levels in
Overweight Adults. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LCBS-NMK-147, Version 1.0 dated 25 Sep 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harshith C S |
| Designation |
Assistant Professor |
| Affiliation |
BGS Global Institute of Medical Sciences |
| Address |
No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA
560060
India |
| Phone |
9741073960 |
| Fax |
|
| Email |
drharshithcs.research@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd |
| Address |
Department of Clinical Research, No.9, 1st Floor, Mythri Legacy, Chelekere Main Road, Kalyan Nagar
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd |
| Address |
Department of Clinical Research, No.9, 1st Floor, Mythri Legacy, Chelekere Main Road, Kalyan Nagar
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Leads Clinical Research and Bio Services Pvt. Ltd. No.9, 1st Floor, Mythri Legacy, Chelekere Main Road, Kalyan Nagar, Bangalore 560043, Karnataka, India
|
|
|
Primary Sponsor
|
| Name |
Leads Clinical Research and Bio Services Pvt. Ltd. |
| Address |
No.9, 1st Floor, Mythri Legacy, Chelekere Main Road, Kalyan Nagar, Bangalore 560043, Karnataka, India
|
| Type of Sponsor |
Other [Manufacturer of natural plant based Food ingredients and Nutraceutical ingredients] |
|
|
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 Harshith C S |
BGS Global Institute of Medical Sciences |
Room No. 3, Department of General Medicine, Ground Floor, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA |
9741073960
drharshithcs.research@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee BGS Global Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E663||Overweight, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Peach Blossom Enzyme-Treated Extract (HT099) |
Oral administration of single dose of HT099 tablet everyday for 84 days |
| Comparator Agent |
Placebo |
Oral administration of single dose of Placebo tablet everyday for 84 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Overweight subjects with BMI between 25-30 kg/m² 2. Subject willing to adhere with their routine diet and exercise regimen throughout the study 3. Females of childbearing age, who agree to use approved birth control methods during the study, and
have negative urine pregnancy test (UPT) at screening 4. Subject willing and able to give informed consent and comply with the study procedures |
|
| ExclusionCriteria |
| Details |
1. Hypertension patients with systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg, or those taking diuretics 2. Diabetes patients with fasting blood glucose ≥ 126 mg/dL or random blood glucose ≥ 200 mg/dL, or those taking oral hypoglycemic agents or insulin 3.Subjects with heart, kidney, liver, thyroid, or cerebrovascular diseases 4. Subjects with gallbladder disease, gastrointestinal diseases, gout, or porphyria 5. Subjects with psychiatric disorders such as depression, schizophrenia, alcoholism, or drug addiction 6. Subjects taking obesity treatments (lipase inhibitors, antidepressants, appetite suppressants, contraceptives, steroids, or female hormones) 7. Pregnant or breastfeeding women 8. Subjects who have taken obesity programs or diet supplements within 30 days prior to the study 9. Subjects who are deemed unable to exercise due to severe musculoskeletal disorders
10. Subjects diagnosed with or treated for cancer within the past 5 years 11. Subjects with asthma or other allergic diseases 12. Subjects with a history of surgery within the past 6 months 13. Subjects with a history of drug or alcohol addiction 14. Subjects who participated in another clinical trial within 3 months prior to the study start date 15. Subjects who cannot read or have limited reading ability 16. Subjects deemed unsuitable by the investigator for any other reason start date
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of HT099 in comparison with placebo on the reduction in body fat mass using Dual Energy X-ray Absorptiometry (DEXA) in overweight subjects |
Baseline and Day 84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean Change in anthropometric parameters and body composition |
Baseline, Day 28, Day 56, Day 84 |
| Mean Change abdominal fat |
Baseline and Day 84 |
| Mean Change in Biomarkers |
Baseline, Day 28, Day 56, Day 84 |
| Overall Safety |
Baseline, Day 28, Day 56, Day 84 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
02/01/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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 double blind, placebo-controlled, randomized, parallel-group study. Adult overweight subjects meeting all inclusion and no exclusion criteria, after signing a written informed consent will be enrolled in the study. After passing the eligibility criteria, subjects will be randomized into 2 treatment arms (50:50) to receive either HT099 or placebo, orally, once a day for 84 days. Each subject will visit the site 5 times during the conduct of the study over a period of 84 days. |