| CTRI Number |
CTRI/2020/04/024679 [Registered on: 16/04/2020] Trial Registered Prospectively |
| Last Modified On: |
09/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A single Dose Clinical study to evaluate the efficacy of a Health supplement on energy ezxpenditure |
|
Scientific Title of Study
|
A Randomized, Double-Blind, Placebo-Controlled, Single dose, Cross-Over Study to Evaluate the Effect of a Dietary Supplement on Energy Expenditure Before, During and Following Low Intensity Exercise. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mamatha K |
| Designation |
Principal investigator |
| Affiliation |
Divakar’s Specialty Hospital |
| Address |
Department of General Medicine,Ground Floor,#220, 9th Cross, 2nd phase, JP Nagar, Next to Nilgiris,
Bangalore
KARNATAKA
560078
India |
| Phone |
9482164779 |
| Fax |
|
| Email |
drmamatharameshk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd |
| Address |
#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 |
#9,1st Floor, Mythri Legacy, Chelekere Main Road, Kalyan Nagar
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
|
Source of Monetary or Material Support
|
| OmniActive Health Technologies Ltd. New Technology Centre, A-10, Road No.1, Wagle Industrial Estate,Thane(W)-400 604, India |
|
|
Primary Sponsor
|
| Name |
OmniActive Health Technologies Ltd |
| Address |
New Technology Centre, A-10, Road No.1, Wagle Industrial Estate,Thane(W)-400 604, 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 Mamatha K |
Divakar’s Specialty Hospital |
Department of General Medicine, Ground Floor, #220, 9th Cross, 2nd phase,JP Nagar, Next to Nilgiris,
Bangalore
KARNATAKA |
9482164779
drmamatharameshk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Divakars Speciality Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Clinically normal |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Oral administration of a single dose of Placebo |
| Intervention |
Thermogenic supplement |
Oral administration of a single dose of Thermogenic supplement |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. BMI between 18.5 to 24.9 kg/m2
2. Subjects with normal TSH (> 0.4 µIU/ml to < 5.5 µIU/ml).
3. Subject is in good health as determined by a health and exercise status questionnaire.
4. Subject will be untrained or recreationally trained
5. Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form
|
|
| ExclusionCriteria |
| Details |
1. Subject has a significant history or current presence of treated or untreated bleeding disorder, metabolic (hyperlipidemia, hyperglycemia), musculoskeletal, diabetes mellitus, high blood pressure [systolic BP> 140 and/or diastolic BP > 90 mm Hg], thyroid disease, tachyarrhythmia, heart disease, kidney disease, or liver disease.
2. Subject currently suffers from a sleep disorder and/or has a known history of (or is currently being treated for) clinical depression, eating disorder(s) or any other psychiatric condition(s), which in the opinion of the investigator, might put the subject at risk and/or confound the results of the study.
3. Subject has lost ≥10 pounds (5 Kilograms) and maintained the weight loss or gained ≥10 pounds (5 Kilograms) during the previous three months.
4. Subject does not eat meals at regular intervals.
5. Subject who is habituated to very spicy food in their diet
6. Subject has a history of alcohol or other drug abuse in the past year.
7. Subject regularly uses tobacco products.
8. Subject has had an abnormal electrocardiogram.
9. Subject regularly takes any of the prohibited concomitant medications listed in the protocol.
10. Subject has a known allergy or sensitivity to any ingredient in thermogenic supplement, including caffeine.
11. Subject has any medical condition or uses any medication, nutritional product, dietary supplement or program, which in the opinion of the investigator, might interfere with the conduct of the study or place the subject at risk.
12. Subject has a history of difficulty swallowing large pills or tablets.
13. Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study
14. Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
15. female subjects pregnant, lactating, planning a pregnancy during the study.
Female subjects
16.Female subject of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study treatment and for 4 weeks after the end of treatment.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of of a thermogenic supplement on Energy Expenditure (EE) and Respiratory Quotient (RQ) as compared to placebo |
Day 0 (Period 1 ) and Day 7 (Period 2) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in VO2, VCO2 and EPOC |
Day 0 (Period 1 ) and Day 7 (Period 2) |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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
|
N/A |
|
Date of First Enrollment (India)
|
18/04/2020 |
| 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="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomized, double-blind, placebo-controlled, single dose, cross-over efficacy study. Adult healthy subjects meeting all inclusion and no exclusion criteria, after signing a written informed consent will be enrolled in the study. During the screening visit,blood samples will be collected for the laboratory assessments. Vital signs, height, weight and BMI will be measured.If the subject is eligible, they will be familiarized with the treadmill and measurements. Subjects will be instructed to refrain from strenuous physical activity for at least 24 hours prior to their next two visits and to eat a normal diet for the two days prior to the visit.All subjects who meet the study entrance criteria will return to the study site for Experimental Visit 2 in a 12-hr fasting state,all safety and efficacy assessments will be performed as per the protocol.Subjects will return to the study site one week following visit 2 in a fasting state for visit 3. All safety and efficacy assessments will be repeated, but each subject will receive the opposite IP consumed at visit 2 (cross-over). During this visit, blood samples will be collected for laboratory analyses |