A Pilot Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Study to Evaluate the Safety and Tolerability of BioPB-01 in Healthy Adults

Vedic Lifesciences Pvt. Ltd.2 sites in 1 country64 target enrollmentApril 27, 2023

ConditionsMetabolic Syndrome

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Metabolic Syndrome
Sponsor: Vedic Lifesciences Pvt. Ltd.
Enrollment: 64
Locations: 2
Primary Endpoint: To evaluate the safety of 21 days of BioPB-01 administration on
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The present study is a randomized, placebo-controlled, parallel-group, double-blind clinical study. Seventy-eight individuals will be screened, and considering a screening failure rate of 20%, approximately 64 participants will be randomized in a ratio of 1:1 to receive either BioPB-01 or Placebo

Registry

clinicaltrials.gov

Start Date

April 27, 2023

End Date

September 12, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Vedic Lifesciences Pvt. Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participants who are 25 to 55 years of age (inclusive) at the time ofsigning the informed consent form.
•Participants having good general health (no active or uncontrolled diseases, infections, or conditions).
•BMI within the range of 24.9 to 34.9 kg/m2 (inclusive).
•Random blood glucose level \<140 mg/dL.
•Concurrent metformin use is acceptable for indications other than diabetes. (However, the subject and investigator must not change metformin dosing during the three weeks of the study).
•Non-pregnant and non-lactating females of childbearing potential who agree to use adequate contraception/sexual abstinence throughout the study period.
•Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.
•Individuals with access to a digital device to fill out the questionnaires.

Exclusion Criteria

•Participant has a history of uncontrolled hypertension (i.e., ≥150 mmHg systolic and/or ≥110 mmHg diastolic).
•Participant with history of post-prandial hypoglycemia (occurring 2-5 hours after food intake) of unknown cause.
•Abnormal thyroid-stimulating hormone (TSH) levels (\<0.4 or \> 4.2 μIU/ml).
•Known case of Type 1 or 2 diabetes.
•Participant has a history of heart disease and/or cardiovascular disease, kidney disease (dialysis or renal failure), and/or hepatic impairment or disease.
•Participant has a history of previously diagnosed major affective disorder, psychiatric disorder that required hospitalization in the year prior to screening, immune disorder (i.e., HIV/AIDS), or a history of cancer (except localized skin cancer without metastases or in situ cervical cancer) within 5 years prior to the screening visit.
•Received a vaccine for COVID-19 or any other vaccination in the 2 weeks prior to screening or planned during the study period, currentCOVID-19 infections, or currently have the post COVID-19 condition as defined by the World Health Organization (WHO) (i.e., individuals with a history of probable or confirmed SARS-CoV-2 infection, usually 3 months from the onset of COVID-19 with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis).
•Have a known intolerance, sensitivity, or allergy to any of the study products, their ingredients, or any excipients used in the formulation.
•Individuals who have a known history of diverticulitis.
•Have a known intolerance, sensitivity, or allergy to milk or soy.

Outcomes

Primary Outcomes

To evaluate the safety of 21 days of BioPB-01 administration on

Time Frame: Throughout the study (an average of 21 days)

The number and percentage of participants having adverse product reaction (as per CTCAE V5.0)

Secondary Outcomes

To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing the metabolic health(Day 21)
To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing Fecal short chain fatty acids (SCFA)(Day 21)
To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing(Day 21)