About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
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
Trial design
Crossover
Treatments tested in this trial
Phaseolean (White Kidney Bean Extract) 1000 milligrams
Dietary supplementThe 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 milligrams
Dietary supplementThe 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 Powder
Other interventionMode 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
Other interventionParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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
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.
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.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
NovoBliss Research Pvt Ltd
Lead sponsor
Ambe Phytoextracts Pvt. Ltd
Collaborator
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