None listed
Conditions
Interventions
Intervention1: 1000 mg of Phaseolean: Mode of Usage: Dissolve one sachet of product in 50-100 ml of water and consume Frequency: Once Daily Route of administration: Oral Dosage Form: Powder Storage Co
Sponsors
Ambe Phytoextracts Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Age 18 to 45 years (both inclusive) at the time of consent Sex male and non-pregnant and non-lactating female. Females of childbearing potential must have a negative urine pregnancy test performed on screening visits. Participants having fasting blood glucose levels less than 100 mg per dL. Participants with a Body Mass Index of 18.5 to 25 kg 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
Exclusion criteria
Exclusion criteria: 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 ml. 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 HIV test. History of Hepatitis B or C virus self reported
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To determine the glycemic response to carbohydrate rich meal (with high GI) consumed with test products in healthy participants under in-vivo conditionsTimepoint: At baseline and 15, 30, 45, 60, 90 and 120 minutes post consumption on Day 1, Day 5, Day 9, Day 13, day 21, day 29 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To evaluate the efficacy of the test products on carbohydrate rich meal (with high GI) by assessing change in satiety level (hunger, fullness & desire to eat) by using visual analogue scale based subjective questionnaire 2.To evaluate the efficacy of the test products on carbohydrate rich meal (with high GI) by assessing change in glycemic Load by standard calculation method. 3.To evaluate the efficacy of the test products on carbohydrate rich meal (with high GI) by assessing change in Calorie Index by standard calculation method.Timepoint: 1.At baseline and after 30, 60, 90 and 120 minutes post consumption at day 1, day 5, day 9, day 13, day 21, day 29 2.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.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 | — |
Countries
India
Contacts
Public ContactDr Maheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed