HealthyPHEGINCT07466667
To Determine the Effect of Phaseolean on Glycemic Response to Carbohydrate Rich Meal in Healthy Adult Human Participants
A study testing Phaseolean (White Kidney Bean Extract) 1000 milligrams, Phaseolean (White Kidney Bean Extract) 2000 milligrams and Anhydrous Glucose Powder in people with Healthy, run by NovoBliss Research Pvt Ltd at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Phaseolean (White Kidney Bean Extract) 1000 milligrams, Phaseolean (White Kidney Bean Extract) 2000 milligrams and Anhydrous Glucose Powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteIndia
- Study dates
- 19 Mar 2026to 29 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1)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.
- 4) Participants having fasting blood glucose levels less than 100 milligrams per decilitre.
- 5) Participants with a Body Mass Index of 18.5 to 25 kilogram per meter square (both inclusive).
- 6) Participant is in good general health as determined by the Investigator on the basis of medical history and vital signs.
- 7) Participants should be willing and able to follow the study protocol to participate in the study.
- 8) Participant must be able to understand and provide written informed consent to participate in the study.
- 9) Participant is willing to refrain from vigorous physical exercise during the study period.
- 10) Participants is willing to stay overnight as per study specification requirements.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Phaseolean (White Kidney Bean Extract) 1000 milligrams, Phaseolean (White Kidney Bean Extract) 2000 milligrams, Anhydrous Glucose Powder, Plain white bread
- Keywords
- Phaseolean, Glycemic Response, Anhydrous Glucose Powder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phaseolean (White Kidney Bean Extract) 1000 milligramsDietary 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)
Phaseolean (White Kidney Bean Extract) 2000 milligramsDietary 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)
Anhydrous Glucose PowderOther
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)
Plain white breadOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: 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. Receives: Other: Plain white bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
By assessing change in satiety level (hunger, fullness \& desire to eat) by using visual analogue scale based subjective questionnaire
Measured: 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)
By assessing change in glycemic Load by standard calculation method.
Measured: 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)
By assessing change in Calorie Index by standard calculation method.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start19 Mar 2026
- Primary completion29 Apr 2026
- Study completion29 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovoBliss Research Pvt Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Ambe Phytoextracts Pvt. Ltd
- Responsible party
- Sponsor
- Investigators
- Nayan Patel, Study director, NovoBliss Research Pvt Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466667
- Sponsor's protocol ID
- NB260014-AP_1.0_24Feb26
- Acronym
- PHEGI
- Status last verified
- Aug 2026
- First submitted
- 7 Mar 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07466667
- Acronym / sponsor ID
- PHEGI / NB260014-AP_1.0_24Feb26
- Conditions
- Healthy
- Keywords
- Phaseolean, Glycemic Response, Anhydrous Glucose Powder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- NovoBliss Research Pvt LtdUniversity, hospital or other
- Collaborators
- Ambe Phytoextracts Pvt. Ltd
- Study start
- 19 Mar 2026 (actual)
- Primary completion
- 29 Apr 2026 (actual)
- Study completion
- 29 Apr 2026 (actual)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Plain white bread + 1000 milligrams Phaseolean | Experimental | Dietary Supplement: Phaseolean (White Kidney Bean Extract) 1000 milligramsThe 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 | Experimental | Dietary Supplement: Phaseolean (White Kidney Bean Extract) 2000 milligramsThe 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) |
| Anhydrous Glucose Powder | Experimental | Other: Anhydrous Glucose PowderMode 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) |
| Plain white bread | Experimental | Other: Plain white breadParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 1)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.
- 4) Participants having fasting blood glucose levels less than 100 milligrams per decilitre.
- 5) Participants with a Body Mass Index of 18.5 to 25 kilogram per meter square (both inclusive).
- 6) Participant is in good general health as determined by the Investigator on the basis of medical history and vital signs.
- 7) Participants should be willing and able to follow the study protocol to participate in the study.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phaseolean (White Kidney Bean Extract) 1000 milligramsThe 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 | Plain white bread + 1000 milligrams Phaseolean |
| Phaseolean (White Kidney Bean Extract) 2000 milligramsThe 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 | Plain white bread + 2000 milligram Phaseolean |
| Anhydrous Glucose PowderMode 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 breadParticipants 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 |
Primary outcome
To determine the glycemic response to carbohydrate rich meal (with high Glycemic Index)
Time frame: 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
When consumed with test products in healthy participants under in-vivo conditions.
3 secondary outcomes
To evaluate the efficacy of the test products on carbohydrate rich meal (with high Glycemic Index)
Time frame: 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)
Time frame: 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)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nayan Patel study director
NovoBliss Research Pvt Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phaseolean (White Kidney Bean Extract) 1000 milligrams, Phaseolean (White Kidney Bean Extract) 2000 milligrams and Anhydrous Glucose Powder in people with Healthy, run by NovoBliss Research Pvt Ltd at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the glycemic response to carbohydrate rich meal (with high Glycemic Index) (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.