A Randomized Double-Blind, Placebo-Controlled, Parallel Multicenter Phase Ii Study To Evaluate The Effectiveness And Safety Of Akkermansia Muciniphila Strain On Glucose And Cholesterol Profile Reduction & Metabolic Study

Study Title- A Randomized double-blind, placebo-controlled, parallel multicenter phase III study to evaluate the effectiveness and safety of Akkermansia muciniphila strain on glucose and cholesterol profile reduction and metabolic study

Study Population- 60 patients (Male and female)

Study Duration- 2 months (60 days)

Study Design- A randomized double-blind, placebo-controlled, parallel,multi-center, phase 3 clinical trial.

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 for atleast 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 –

1. Patients with Systolic blood pressure less than or equal 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

Dose and Mode of Administration-

Take one capsule or as directed, best taken prior to a meal.

Frequency- One Capsule or as directed

Route of Administration- Oral

Primary Outcome Measure-

• 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 Day

Secondary Outcome Measures-

• Change in Post prandial Blood sugar level from baseline to day 60.

• Change in HbA1c level from baseline to day 60

• Change in Insulin sensitivity and secretion level from baseline to day 60.

• Change in Body weight from baseline to day 60.

• Change in Body mass index from baseline to day 60

• Change in Waist circumference from baseline to day 60

• Change in Blood pressure level from baseline to day 60.

Clinical evaluation-

• Haematological and hepatic biomarkers were analyzed following the standard medical test protocols at screening (baseline) and end of treatment (Day 60)
• Vital signs measurement and physical examination will be carried out all visits

Evaluation Schedule-

Visit 01(Day 01) Baseline-

• Informed consent

• Demographic data

• Medication history

• Physical examination

• Vital signs

• Checking of eligibility criteria

• Randomization

• Dispensing of study medication

• Fasting Blood sugar level

• Post prandial Blood sugar level

• Body weight • Body mass index

• Waist circumference

• Blood pressure

• HbA1c

• Lipid profile

• Subject treatment and diary filling instruction

• Providing patient diary

Visit 05 (Day 60 ± 3 days) End of Treatment

• Medication history

• Physical examination

• Vital signs

• Randomization

• Dispensing of study medication

• Fasting Blood sugar level

• Post prandial Blood sugar level.

• Body weight

• Body mass index

• Waist circumference

• Blood pressure

• HbA1c

• Lipid profile

• Subject treatment and diary filling instruction

• Providing patient diary

• Collection of patient diary and checking treatment compliance

Safety Endpoints-

• Number of participants who experienced at least one Adverse Event during the study duration.

• Number of participants who discontinued study drug due to an Adverse Event during the study

Ethical Considerations-

The study will be conducted as per the National Ethical Guidelines for Biomedical and Health Research involving Human participants ICMR (2017), ICH (Step 5) ’Guidance on Good Clinical Practice’, New Drugs and Clinical Trials Rules 2019 G.S.R. 227(E) dated 19 Mar 2019, ’Good Laboratory Practice’, ‘Good Clinical Practices for Clinical Research in India’ Guidelines, Good Clinical Laboratory Practice (GCLP) and Declaration of Helsinki (Fortaleza, October 2013).