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

NCT07466667 | Not Yet Recruiting

• 1 other identifier: NB260014-AP_1.0_24Feb26
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Keywords

Phaseolean; Glycemic Response; Anhydrous Glucose Powder

Outcome Measures

Primary Outcomes (1)

• To determine the glycemic response to carbohydrate rich meal (with high Glycemic Index)

  When consumed with test products in healthy participants under in-vivo conditions.

  At baseline and after 15, 30, 45, 60, 90 and 120 minutes post consumption on day 1, day 5, day 9, day 13, day 21, day 29

Secondary Outcomes (3)

• To evaluate the efficacy of the test products on carbohydrate rich meal (with high Glycemic Index)

  At baseline and after 30, 60, 90 and 120 minutes post consumption on day 1, day 5, day 9, day 13, day 21, day 29

• To evaluate the efficacy of the test products on carbohydrate rich meal (with high Glycemic Index)

  At baseline and after 15, 30, 45, 60, 90 and 120 minutes post consumption on day 1, day 5, day 9, day 13, day 21, day 29

• To evaluate the efficacy of the test products on carbohydrate rich meal (with high Glycemic Index)

  At baseline and after 15, 30, 45, 60, 90 and 120 minutes post consumption on day 1, day 5, day 9, day 13, day 21, day 29

Study Arms (4)

Plain white bread + 1000 milligrams Phaseolean

EXPERIMENTAL

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)

Dietary Supplement: Phaseolean (White Kidney Bean Extract) 1000 milligrams

Plain white bread + 2000 milligram Phaseolean

EXPERIMENTAL

The test product(s) will be dissolved in 50-100 mililitre 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)

Dietary Supplement: Phaseolean (White Kidney Bean Extract) 2000 milligrams

Anhydrous Glucose Powder

EXPERIMENTAL

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: Anhydrous Glucose Powder

Plain white bread

EXPERIMENTAL

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.

Other: Plain white bread

Interventions

Phaseolean (White Kidney Bean Extract) 1000 milligrams DIETARY_SUPPLEMENT

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)

Plain white bread + 1000 milligrams Phaseolean

Phaseolean (White Kidney Bean Extract) 2000 milligrams DIETARY_SUPPLEMENT

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)

Plain white bread + 2000 milligram Phaseolean

Anhydrous Glucose Powder OTHER

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)

Anhydrous Glucose Powder

Plain white bread OTHER

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.

Plain white bread

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• )Age: 18 to 45 years (both inclusive) at the time of consent Sex: male and non-pregnant/non-lactating female. 3) Females of childbearing potential must have a negative urine pregnancy test performed on screening visits.
• \) Participants having fasting blood glucose levels less than 100 milligrams per decilitre.
• \) Participants with a Body Mass Index of 18.5 to 25 kilogram per meter square (both inclusive).
• \) Participant is in good general health as determined by the Investigator on the basis of medical history and vital signs.
• \) Participants should be willing and able to follow the study protocol to participate in the study.
• \) Participant must be able to understand and provide written informed consent to participate in the study.
• \) Participant is willing to refrain from vigorous physical exercise during the study period.
• \) Participants is willing to stay overnight as per study specification requirements.

You may not qualify if:

• Participant has any known food allergy or intolerance to any food or beverages.
• Participant is taking any medication in the past one week.
• Participants should not be taking any medications known to affect glucose tolerance (excluding oral contraceptives) - stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis are acceptable
• Participants should not have any known food allergy or intolerance
• Presence of any chronic disease or illness in the past three months or any clinically significant on-going chronic medical illness e.g. Congestive cardiac failure, Hepatitis, Hypotensive episodes, etc.
• Recent history of dehydration from diarrhoea, vomiting or any other reason within a period of 24 hours prior to the study.
• Participation in any similar clinical trial within the past 90 days with blood loss more than 450 millilitre.
• An unusual diet, special diet, for whatever reason e.g. high protein diet, low sodium diet, for two weeks prior to receiving any test food and throughout the Participant's participation in the study.
• Participant has performed vigorous physical exercise in the morning on dosing day.
• Pregnant or lactating females.
• Self-reported Positive Human Immunodeficiency Virus test.
• History of Hepatitis B or C virus self-reported

Sponsors & Collaborators

• NovoBliss Research Pvt Ltd: lead
• Ambe Phytoextracts Pvt. Ltd: collaborator

Study Officials

• Nayan Patel

  NovoBliss Research Pvt Ltd

  STUDY DIRECTOR

Central Study Contacts

Maheshvari Patel

CONTACT

+91 9909013236; maheshvari@novobliss.in

Sheetal Khandwala

CONTACT

bd@novobliss.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2026
• First Posted: March 12, 2026
• Study Start: March 16, 2026
• Primary Completion: April 14, 2026
• Study Completion: April 30, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share