Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: AFO-202 strain of Aureobasidium pullulans produced β 1,3-1,6 Glucan s (Beta Glucan): Dose : 3 sachets, each 1gm of 42 mg active ingredient per day
Dosage : one to be taken 30 minutes
Sponsors
NichiIn Bio Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults between the ages of 18 of 65 years (both ages and all genders inclusive) 2. Subjects with history of Diabetes Mellitus Type II (as defined by ADA) treated only by OHA and/or Insulin 3. Subjects who are non-alcoholic and non-smokers/non-users of tobacco. 4. Subject/LAR who is willing to give informed consent for participation, able to comprehend and understand the responsibilities during treatment period and follow up 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 with allergy, sensitivity or intolerance to the study drugs and their formulation ingredients 2. Subjects who are taking other dietary supplements 3. Subjects who are on regular probiotic or prebiotic intake (more than 2 months) 4. Subjects with Organic insufficiencies (cardiac, hepatic, renal, respiratory), or with immunodeficiencies (HIV, chemotherapy, radiotherapy, transplanted). 5. Subjects with Acute and / or chronic intestinal pathologies (malabsorption syndrome, celiac disease, chronic inflammatory bowel diseases, among others.) 6. Subjects who have participated in any clinical study within 3 months from the date of enrolment. 7. Females who are pregnant or lactating or planning to become pregnant during the study period. 8. Subjects who 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.Fasting Blood Glucose : Reduction of 5% from baseline 2.Post Prandial Blood Glucose : Reduction of 5% from baseline 3.HbA1C : Reduction of 5% from baseline 4.Glycated Albumin : Reduction of 5% from baseline 5.Plasma Fetuin A : Reduction of 5% from baseline 6. Plasma Analysis of Amino Acid Timepoint: 1.Fasting Blood Glucose : Day 1, Day 30 2.Post Prandial Blood Glucose : Day 1, Day 30 3.HbA1C : Day 1, Day 30 4.Glycated Albumin : Day 1, Day 30 5.Plasma Fetuin A : Day 1, Day 30 6. Plasma Analysis of Amino Acid : Day 1, Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Plasma Lipids (Total Cholesterol, LDL Triglycerides) : Maintenance or Reduction of 5% from baseline 2. Plasma Lipids (HDL) : Maintenance or Increase of 5% from baseline 3. Safety Assessments : CBC, ESR. CRP Timepoint: 1. Plasma Lipids (Total Cholesterol, LDL Triglycerides) : Day 1, Day 30 2. Plasma Lipids (HDL) : Day 1, Day 30 3. Safety Assessments : CBC, ESR. CRP : Day 1, Day 30 | — |
Countries
India
Contacts
Public ContactDr Preethy SP
Nichi-In Bio Sciences Pvt. Ltd.
Outcome results
None listed