Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:29 AM
Study NCT ID:
NCT07466667
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-25
First Post:
2026-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Determine the Effect of Phaseolean on Glycemic Response to Carbohydrate Rich Meal in Healthy Adult Human Participants
Sponsor:
NovoBliss Research Pvt Ltd
Organization:
Study Overview
Official Title:
An Open-Label, Randomized, Three-Way, Three-Arm, Crossover, Balance Study to Evaluate the Effect of Phaseolean on Healthy Glycemic Response to Carbohydrate- Rich Meals in Healthy Adult Participants Using an In Vivo Method
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PHEGI
Brief Summary:
This is an Open-Label, Randomized, Three-Way, Three-Arm, Crossover, Balance Study to Evaluate the Effect of Phaseolean on Glycemic response to carbohydrate rich meals in Healthy Adult Participants Using an In Vivo Method.
Detailed Description:
A total of 12 participants including male and non-pregnant/non-lactating females aged between 18-45 years will be enrolled in the study to complete evaluation of 10 participants for the study.
In accordance with guidance ISO 26642:2010, participants will be tested for test products once and reference food thrice in random order on separate days, with at least a 2 days washout period between measurements to minimize carry-over effects. The potential participants will be screened on the basis of inclusion and exclusion criteria only after obtaining written informed consent from the participants. Participants will be contacted telephonically by the recruiting department prior to the enrolment visit. The participants will be requested to bring any previous medications and relevant laboratory reports (if any) on the day of the study visit.
Upon qualification for the study, participants will undergo in the glycemic index evaluation. Each qualified Participant will receive reference product thrice in random order on separate days, with at least a 2 days washout period. Following completion of the reference product phase, participants will receive the test product(s) as per the predefined randomization under a crossover design, with a washout period of seven (7) days. Participants will be asked to stay fasted overnight for 10-12 hours or more before ingesting reference product or test product. The participant will then rate the test product's satiety level in comparison with reference product. The participant will be evaluated for a final evaluation by the investigator at the end of the study.
Safety will be assessed throughout the study by monitoring of adverse events.
The participants will be instructed to visit the facility as per the below visits:
* Period 1 (Visit 1) Day 0: Screening, Enrolment phase, Overnight stay
* Day 1: 1st time reference product consumption
* Then Washout Period (2 Days)
* Period 2 (Visit 2) Day 4: Admission and Overnight stay
* Day 5: 2nd time reference product consumption
* Then Washout Period (2 Days)
* Period 3 (Visit 3) Day 8: Admission and Overnight stay
* Day 9: 3rd time reference product consumption
* Then Washout Period (2 Days)
* Period 4 (Visit 4) Day 12: Admission and Overnight stay
* Day 13: Test product consumption (per randomization)
* Then Washout Period (7 Days) - Cross Over Design
* Period 5 (Visit 5) Day 20: Admission and Overnight stay
* Day 21: Test product consumption (per randomization)
* Then Washout Period (7 Days) - Cross Over Design
* Period 6 (Visit 6) Day 28: Admission and Overnight stay
* Day 29: Test product consumption (per randomization)
In accordance with guidance ISO 26642:2010, participants will be tested for test products once and reference food thrice in random order on separate days, with at least a 2 days washout period between measurements to minimize carry-over effects. The potential participants will be screened on the basis of inclusion and exclusion criteria only after obtaining written informed consent from the participants. Participants will be contacted telephonically by the recruiting department prior to the enrolment visit. The participants will be requested to bring any previous medications and relevant laboratory reports (if any) on the day of the study visit.
Upon qualification for the study, participants will undergo in the glycemic index evaluation. Each qualified Participant will receive reference product thrice in random order on separate days, with at least a 2 days washout period. Following completion of the reference product phase, participants will receive the test product(s) as per the predefined randomization under a crossover design, with a washout period of seven (7) days. Participants will be asked to stay fasted overnight for 10-12 hours or more before ingesting reference product or test product. The participant will then rate the test product's satiety level in comparison with reference product. The participant will be evaluated for a final evaluation by the investigator at the end of the study.
Safety will be assessed throughout the study by monitoring of adverse events.
The participants will be instructed to visit the facility as per the below visits:
* Period 1 (Visit 1) Day 0: Screening, Enrolment phase, Overnight stay
* Day 1: 1st time reference product consumption
* Then Washout Period (2 Days)
* Period 2 (Visit 2) Day 4: Admission and Overnight stay
* Day 5: 2nd time reference product consumption
* Then Washout Period (2 Days)
* Period 3 (Visit 3) Day 8: Admission and Overnight stay
* Day 9: 3rd time reference product consumption
* Then Washout Period (2 Days)
* Period 4 (Visit 4) Day 12: Admission and Overnight stay
* Day 13: Test product consumption (per randomization)
* Then Washout Period (7 Days) - Cross Over Design
* Period 5 (Visit 5) Day 20: Admission and Overnight stay
* Day 21: Test product consumption (per randomization)
* Then Washout Period (7 Days) - Cross Over Design
* Period 6 (Visit 6) Day 28: Admission and Overnight stay
* Day 29: Test product consumption (per randomization)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: