NCT07466667

To Determine the Effect of Phaseolean on Glycemic Response to Carbohydrate Rich Meal in Healthy Adult Human Participants

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: NovoBliss Research Pvt Ltd · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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)

Conditions

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Phaseolean (White Kidney Bean Extract) 1000 milligrams	The test product(s) will be dissolved in 50-100 millilitre of water and consumed by the participants. After 10 minutes of consuming the test product(s), participants will be given plain white bread containing approximately 50 grams of glycemic carbohydrates per serving, along with 30 millilitres of tea or coffee with milk sweetened using a non-nutritive sweetener. Route of Administration: Oral Storage Condition: Room temperature (15 Degree Celsius to 30 Degree Celsius)
DIETARY_SUPPLEMENT	Phaseolean (White Kidney Bean Extract) 2000 milligrams	The test product(s) will be dissolved in 50-100 millilitre of water and consumed by the participants. After 10 minutes of consuming the test product(s), participants will be given plain white bread containing approximately 50 grams of glycemic carbohydrates per serving, along with 30 millilitre of tea or coffee with milk sweetened using a non-nutritive sweetener. Route of Administration: Oral Storage Condition: Room temperature (15 Degree Celsius to 30 Degree Celsius)
OTHER	Anhydrous Glucose Powder	Mode of Administration: 50 grams of anhydrous glucose powder will be dissolved in 250 millilitre of potable water Route of Administration: Oral Storage Condition: Room temperature (15 Degree Celsius to 30 Degree Celsius)
OTHER	Plain white bread	Participants will be given plain white bread containing approximately 50 grams of glycemic carbohydrates per serving, along with 30 millilitre of tea or coffee with milk sweetened using a non-nutritive sweetener.

Timeline

• Start date: 2026-03-16
• Primary completion: 2026-04-14
• Completion: 2026-04-30
• First posted: 2026-03-12
• Last updated: 2026-03-25