| CTRI Number |
CTRI/2026/02/103219 [Registered on: 06/02/2026] Trial Registered Prospectively |
| Last Modified On: |
06/02/2026 |
| 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 Pilot Study to Evaluate the Effect of White Kidney Bean (Phaseolus vulgaris) Extract - Phaseolean® on GLP-1 Levels in Pre-Diabetic Adults |
|
Scientific Title of Study
|
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Pilot Study to Evaluate the Dose-Related Effects of White Kidney Bean (Phaseolus vulgaris) Extract - Phaseolean® on Fasting and Post-Prandial Serum GLP-1 (Glucagon Like Peptide 1) Levels in Pre-diabetic Adults. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B06850; Version: 01, Dated 31 Jan 26 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Divya Mori |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department, Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off. Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad. Gujarat
Phone: 079066135601
Ahmadabad
GUJARAT
380054
India |
| Phone |
9773262487 |
| Fax |
|
| Email |
damori@cliantha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Mori |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department, Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off. Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad. Gujarat
Phone: 079066135601
Ahmadabad
GUJARAT
380054
India |
| Phone |
9773262487 |
| Fax |
|
| Email |
damori@cliantha.com |
|
Details of Contact Person
Public Query
|
| Name |
Shashi Singh |
| Designation |
AGM-Regulatory Affairs, R&D and Clinical Research |
| Affiliation |
Ambe Phytoextracts Pvt. Ltd. |
| Address |
A-144, A Block,
Sector 63, Noida,
Uttar Pradesh – 201301
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9319297745 |
| Fax |
|
| Email |
Shashi.singh@ambe-group.com |
|
|
Source of Monetary or Material Support
|
| Ambe Phytoextracts Pvt. Ltd., A-144, A Block, Sector 63, Noida, Uttar Pradesh - 201301 |
| Cliantha Research, Corporate House 17, Sigma 1 Corporate House, BH. Rajpath Club, Off Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054, Gujarat, India. |
|
|
Primary Sponsor
|
| Name |
Ambe Phytoextracts Pvt. Ltd. |
| Address |
A-144, A Block, Sector 63, Noida, Uttar Pradesh – 201301 |
| Type of Sponsor |
Other [Manufacture of ingredients-Nutraceuticals, Herbal Extracts, Health Supplements, Botanicals] |
|
|
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 Divya Mori |
Cliantha Research |
Consumer Research Department,
Corporate House 17, Sigma 1 Corporate House, BH. Rajpath Club, Off Sindhubhavan Road,
Nr. Mann Party Plot Cross Road,
Bodakdev, Ahmedabad-380054, Gujarat.
Phone# +91-79-66135601
Ahmadabad
GUJARAT |
9773262487
damori@cliantha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OM Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R730||Abnormal glucose, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
250 mg Tablet |
3 tablets daily—one tablet before breakfast, one before lunch, and one before dinner.
Daily consumption (15 mins before proper meal) for duration of 28 Days
|
| Intervention |
500 mg Tablet |
3 tablets daily—one tablet before breakfast, one before lunch, and one before dinner.
Daily consumption (15 mins before proper meal) for duration of 28 Days
|
| Comparator Agent |
Placebo Tablet |
3 tablets daily—one tablet before breakfast, one before lunch, and one before dinner.
Daily consumption (15 mins before proper meal) for duration of 28 Days
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult males and non-lactating/non-pregnant female participants between ages of 18 to 55 years (both inclusive at the time of consent).
2. Participants with BMI between 25–32 kg/m² (Overweight to Class I Obese).
3. Prediabetic participants with HbA1c between 5.7–6.4%.
4. Participants having good general health as determined by the Investigator on the basis of medical history and physical examination.
5. Participants of childbearing potential:
o must have a negative urine pregnancy test performed during screening.
o willing to follow all the acceptable forms of contraception as applicable.
6. Participants willing to consume test products throughout the study period as instructed.
7. Participants who are not planning to relocate or planning to take vacation for more than 2 to 3 days.
8. Participants who are willing to maintain a consistent diet and lifestyle routine throughout the study.
9. Participants who are willing to voluntarily participate in the study and provide signed informed consent.
10. Participants should be willing and able to follow the study protocol to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Participants with known allergy to the legumes, extract or related herbal extracts.
2. Participants with known allergy or hypersensitivity to any ingredients of the test products.
3. Participants who are planning pregnancy during the study period.
4. Participants who are diagnosed with diabetes mellitus (FBG more than or equal to 126 mg/dL or HbA1c more than or equal to 6.5%).
5. Participants who are using antidiabetic, lipid-lowering, or weight-loss medications in the past 2 months.
6. Participants who have a history or are diagnosed gastrointestinal disease that may affect digestion or gut hormone secretion.
7. Participants using medications or supplements known to affect gut hormones.
8. Participants who have tested positive for HIV test.
9. Participants having any chronic illness or health condition such as hyperthyroidism or hypothyroidism, diabetes, Peripheral Artery Disease, CKD, previous major surgery, hepatitis etc. that can interfere with the outcome of the study.
10. Participants undergone any surgical procedure undergone within the past 12 weeks.
11. Participants with a history or presence of significant alcoholism or drug abuse and smoking (more than or equal to 10 cigarettes/day) or consumption of tobacco products.
12. Any other significant disease or disorder that, in the opinion of the investigator, may affect the trial results or the participants ability to participate effectively.
13.Participants who have participated in another clinical trial within the 30 days prior to screening. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the impact of the product on serum GLP-1 levels, assessed using incremental area under the curve (iAUC), maximum observed concentration (Cmax), and time to maximum concentration (Tmax) |
Visit 01 and Visit 02
(Fasting Condition and at 30 mins 60 mins, 90 mins & 120 mins following product consumption) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the impact of the product on serum peptide YY (PYY) and serum ghrelin levels (dose-response trends) |
Visit 01 and Visit 02 (Fasting Condition and at 30 mins 60 mins, 90 mins & 120 mins following product consumption)
|
| To evaluate the impact of product on blood glucose levels, assessed using incremental area under the curve (iAUC), maximum observed concentration (Cmax), and time to maximum concentration (Tmax) |
Visit 01 and Visit 02 (Fasting Condition and at 30 mins 60 mins, 90 mins & 120 mins following product consumption) |
| To evaluate the impact of product on blood insulin levels, assessed using incremental area under the curve (iAUC), maximum observed concentration (Cmax), and time to maximum concentration (Tmax) |
Visit 01 and Visit 02 (Fasting Condition and at 30 mins 60 mins, 90 mins & 120 mins following product consumption) |
| To explore the relation between GLP-1 and Post prandial glucose excursion (Exploratory endpoint). |
Throughout 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
|
N/A |
|
Date of First Enrollment (India)
|
17/02/2026 |
| 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="1"
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
|
This is an exploratory,
interventional, randomized, double-blind, placebo-controlled, parallel group,
three arm, comparative pilot study to determine the dose-related effects of
White Kidney Bean (Phaseolus vulgaris) extract - Phaseolean® on fasting and
post-prandial serum GLP-1 (Glucagon Like Peptide 1) levels in pre-diabetic
adults.
The potential
participants will be screened as per the inclusion and exclusion criteria only
after obtaining written informed consent from the participants.
The study will be
conducted over a duration of 30 days and will include 3 visits including
screening visit. All eligible participants will undergo laboratory evaluation (blood tests).
Safety will be assessed throughout the study by monitoring adverse events.
Additionally, vital signs will be monitored and changes, if any, in the
laboratory parameters (CBC,
LFT, RFT, Lipid parameters and glucose) will be documented. |