Health Condition 1: R730- Abnormal glucose
Conditions
Interventions
Intervention1: Glucophil - Treatment Arm I - Euglycemic: Dose - 2 g per intake.
Dosage - 2 g to be dissolved in 200 mL of lukewarm water, mixed well and consumed 10 minutes before high carbohydrate me
Sponsors
K.-W. Pfannenschmidt GmbH
Aurous HealthCare Research and Development India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Treatment Arm I 1. Clinically healthy volunteers aged between 18 and 75 years (all genders) 2. Subjects with HbA1C less than 5.7 per cent at the time of screening Treatment Arm II 1. Prediabetic adults aged between 18 and 75 years (all genders). 2. Subjects with HbA1C between 5.7 per cent & 6.4 per cent at the time of screening 3. Naive subjects or subjects who have not consumed any medicine or product or supplement intended towards management of glucose levels, carbohydrate metabolism for 30 days prior to screening and willing to abstain during the study period. Both Treatment Arms 1. Subjects who are not currently on a specialized diet not limited to low carb high protein, keto, paleo etc. and have not attempted such a diet for 30 days prior to screening. 2. Subjects who have not started any specified physical activity not limited to yoga, Pilates, aerobic, strength training or 10 K steps per day regimen, upto 30 days prior to screening. 3. Subjects who are not any medicine or product or supplement intended towards weight management, weight loss etc. 4. Subjects who are willing to give informed consent for participation, able to comprehend and understand the responsibilities during screening and treatment period. 5. Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
Exclusion criteria
Exclusion criteria: 1. Subjects who are obese. BMI greater than 30 kg per m2. 2. Subjects who have an active infection, disease or disorder that will prevent them from fully satisfying the responsibilities of the study. 3. Subjects with history of seizures, uncontrolled diabetes, hypertension or major cardiac illness like congestive heart failure etc. 4. Subjects on remission from cancer of any type less than 5 years at the time of screening. 5. Subjects who are planning a pregnancy and or currently breastfeeding. 6. Subjects who have participated in a clinical study less than 1 month before screening. 7. Any significant medical condition eg - significant psychiatric or neurological disorders, active alcohol or drug abuse etc. any medical condition that is unstable or poorly controlled or other factor - eg. planned relocation that the Investigator felt would interfere with study evaluations and study participation. 8. Subjects who are mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol. 9. Subjects who in the opinion of the Investigator are not eligible for enrolment in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Post Prandial Glucose & Post Prandial Insulin : Dose response curves in euglycemic adults following high carbohydrate meal compared to baseline. 2.Post Prandial Glucose & Post Prandial Insulin: Dose response curves in prediabetic adults following high carbohydrate meal compared to baseline. Timepoint: Fasting Blood Glucose Post Prandial Glucose (30, 60, 90, 120 minutes) Fasting Insulin Post Prandial Insulin (60, 120 minutes) | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDr VT Sriraam
Raam Clinic
Outcome results
None listed