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

ConditionHealthy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorNovoBliss Research Pvt Ltd

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

  • 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)

  • 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)

  • Anhydrous Glucose Powder

    Other intervention

    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 bread

    Other intervention

    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.

Treatment groups

12 Participants
are divided into 4 treatment groups
Group A: Plain white bread + 1000 milligrams PhaseoleanExperimental treatment 1 intervention
Group B: Plain white bread + 2000 milligram PhaseoleanExperimental treatment 1 intervention
Group C: Anhydrous Glucose PowderExperimental treatment 1 intervention
Group D: Plain white breadExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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

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
2

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.

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
3

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.

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

Other outcomes

Locations

This trial has no 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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