Health Condition 1: E139- Other specified diabetes mellituswithout complications
Conditions
Interventions
Intervention1: Akkermansia Muciniphila: Dose: Take one capsule or as directed, best taken prior to a meal.
Frequency: One Capsule or as directed
Route of Administration: Oral
Total Duration of Inter
Sponsors
Vidya Herbs Pvt LTD
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female of age between 31 to 60 years 2. Diagnosis of prediabetes according ADA criteria 3. Body Mass Index from 25 to 34.9 kg per m2 4. Stable weight at least the previous last 3 months 5. Patients willing to provide written informed consent and comply with protocol requirements. 6. Baseline lipid levels: Patients must have a baseline lipid profile within a specified range or above to enable assessment of reduction during the study.
Exclusion criteria
Exclusion criteria: 1. Patients with Systolic blood pressure greater than or equal to 140 mmHg 2. Patients with Diastolic blood pressure less than or equal 90 mmHg 3. Patients with HbA1c less than or equal 6.5% 4. Patients with Triglycerides less than or equal 400 mg/dL 5. Patients with Total cholesterol less than or equal 240 mg/dL 6. Any patient with weight or appetite loss, iron deficiency anemia, fever, or rectal bleeding 7. Known inflammatory bowel disease or celiac disease patients. 8. Immuno-compromised patients 9. Pregnancy or wishing to become pregnant during the study. 10. End-stage kidney failure on dialysis, presence of other diseases, including cancer or severe hepatic insufficiency 11. The use of other probiotic products or antibiotics over the previous 6 months. 12. Participation in other clinical trials 13. The presence of other medical conditions that, in the opinion of the investigators, could jeopardize compliance with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ? Fasting Blood sugar level from baseline to day 60. ? Change in the lipid profile parameters, total cholesterol, low density lipoprotein cholesterol , and high-density lipoprotein cholesterol from baseline to DayTimepoint: Baseline (Day 01) Visit 05 (Day 60) End of study | — |
Secondary
| Measure | Time frame |
|---|---|
| ? Change in Post prandial Blood sugar level. ? Change in HbA1c level. ? Change in Insulin sensitivity and secretion level. ? Change in Body weight. ? Change in Body mass index. ? Change in Waist circumference. ? Change in Blood pressure level. Change in Vitals and Physical Examination.Timepoint: Baseline (Day 01) Visit 05 (Day 60) End of study | — |
Countries
India
Contacts
Public ContactDr Radha Parthasarathy
Srinivasan Rajalakshmi Memorial Hospital (SRMH)
Outcome results
None listed