| CTRI Number |
CTRI/2021/03/032458 [Registered on: 31/03/2021] Trial Registered Prospectively |
| Last Modified On: |
04/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of Green Coffee and Thyme (herb) in patient with high Cholesterol and raised sugar levels |
|
Scientific Title of Study
|
Evaluation of Antihyperlipidemic Potential of Thyme Infused Green Coffee in Human Subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Richa Arora |
| Designation |
PhD Scholar |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Department of Nutrition and Dietetics, Faculty of Allied Health Sciences, Room No. QS9, Block Q, Manav Rachna Educational Institutions, Sector 43, Delhi-surajkund Road, Faridabad- 121004
Faridabad
HARYANA
121004
India |
| Phone |
09582035151 |
| Fax |
|
| Email |
rarora978@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shubhra Saraswat |
| Designation |
Assistant Professor |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Department of Nutrition and Dietetics, Faculty of Allied Health Sciences, Room No. QS9, Block Q, Manav Rachna Educational Institutions, Sector 43, Delhi-surajkund Road, Faridabad- 121004
Faridabad
HARYANA
121004
India |
| Phone |
9990815505 |
| Fax |
|
| Email |
shubhra.fas@mriu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Richa Arora |
| Designation |
PhD Scholar |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Department of Nutrition and Dietetics, Faculty of Allied Health Sciences, Room No. QS9, Block Q, Manav Rachna Educational Institutions, Sector 43, Delhi-surajkund Road, Faridabad- 121004
Faridabad
HARYANA
121004
India |
| Phone |
09582035151 |
| Fax |
|
| Email |
rarora978@gmail.com |
|
|
Source of Monetary or Material Support
|
| Richa Arora
Department of Nutrition and Dietetics, Faculty of Allied Health Sciences, Room No. QS9, Block Q, Manav Rachna Educational Institutions, Sector 43, Delhi-surajkund Road, Faridabad- 121004
Contact : 9582035151 |
|
|
Primary Sponsor
|
| Name |
Richa Arora |
| Address |
Department of Nutrition and Dietetics, Faculty of Allied Health Sciences, Room No. QS9, Block Q, Manav Rachna Educational Institutions, Sector 43, Delhi-surajkund Road, Faridabad- 121004 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Richa Arora |
Manav Rachna International Institute of Research and Studies |
Department of Nutrition and Dietetics, Faculty of Allied Health Sciences, Room No. QS9, Block Q, Manav Rachna Educational Institutions, Sector 43, Delhi-surajkund Road, Faridabad- 121004
Faridabad
HARYANA |
09582035151
richa978@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RESEARCH ETHICS COMMITTEE, MRIIRS, FARIDABAD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
TYPE 2 DIABETES Mellitus, Serum Cholesterol More than 220 mg/dl. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Consumption of Green Coffee Powder |
1. Feeding of 2 grams of green coffee powder available in filtered tea bags with boiled water in the form of beverage twice in a day for 90 days. |
| Comparator Agent |
consumption of Green coffee powder and herb Thyme (Thymus Vulgaris) |
1. Feeding of 2 grams of green coffee powder with 2 grams of herb Thyme available in filtered tea bags with boiled water in the form of beverage twice in a day for 90 days.. |
| Intervention |
Placebo |
No Treatment |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Sedentary to Moderate worker
2. Serum Cholesterol more than 220 mg/dl
3. Fasting blood sugar level more than 90 mg/dl
4. Non Smokers |
|
| ExclusionCriteria |
| Details |
1.Smokers
2. Pregnant and Lactating women
3. Humans with Liver, Renal and Muscle Diseases
4. Humans with Genetic disorders
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Thyme infused green coffee may alter the lipid profile of subjects. |
8 weeks and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Thyme infused green coffee may alter the BMI of subjects. |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/04/2021 |
| Date of Study Completion (India) |
05/09/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - email to principle investigator
- For how long will this data be available start date provided 08-01-2022 and end date provided 08-12-2022?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This study is a Randomized parallel placebo control trial comparing the efficacy of Green Coffee and Green coffee induced with Thyme as beverage in equal doses of 2 grams each for 12 weeks in 100 patients with serum cholesterol level more than 220 mg/dl and fasting blood sugar level more than 90 mg/dl that will be conducted in New Delhi. The primary outcome would measure the effect of both beverages on lipid profile of the subjects in 12 weeks. The secondary outcome will measure the effect of beverages on BMI index of subjects in 12 weeks. |