Clinical trial NCT05839444: A Clinical Study to Evaluate the Safety and Tolerability of BioPB-01 in Healthy Adults
Official title: A Pilot Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Study to Evaluate the Safety and Tolerability of BioPB-01 in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2023-05-03
Enrollment: 64
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, double-blind, placebo-controlled, parallel-group
Primary purpose: OTHER

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


Eligibility criteria: Inclusion Criteria:

1. Participants who are 25 to 55 years of age (inclusive) at the time ofsigning the informed consent form.
2. Participants having good general health (no active or uncontrolled diseases, infections, or conditions).
3. BMI within the range of 24.9 to 34.9 kg/m2 (inclusive).
4. Random blood glucose level \<140 mg/dL.
5. 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).
6. Non-pregnant and non-lactating females of childbearing potential who agree to use adequate contraception/sexual abstinence throughout the study period.
7. 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.
8. Individuals with access to a digital device to fill out the questionnaires.

Exclusion Criteria:

1. Participant has a history of uncontrolled hypertension (i.e., ≥150 mmHg systolic and/or ≥110 mmHg diastolic).
2. Participant with history of post-prandial hypoglycemia (occurring 2-5 hours after food intake) of unknown cause.
3. Abnormal thyroid-stimulating hormone (TSH) levels (\<0.4 or \> 4.2 μIU/ml).
4. Known case of Type 1 or 2 diabetes.
5. Participant has a history of heart disease and/or cardiovascular disease, kidney disease (dialysis or renal failure), and/or hepatic impairment or disease.
6. 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.
7. 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).
8. Have a known intolerance, sensitivity, or allergy to any of the study products, their ingredients, or any excipients used in the formulation.
9. Individuals who have a known history of diverticulitis.
10. Have a known intolerance, sensitivity, or allergy to milk or soy.
11. Any condition or abnormality that, in the opinion of the Investigator, would compromise the safety of the participant or the quality of the study data.
12. Currently taking dietary supplements other than vitamins and minerals.
13. Taking any other prescription medication at the time of randomization that is known to impact blood sugar and or blood sugar metabolism, as per the Principal Investigator's (PI) discretion.
14. History of smoking, alcohol (heavy drinking as defined by NIAAA \[National Institute on Alcohol Abuse and Alcoholism\], USA), or substance abuse in the 12 months prior to screening.
15. Receipt or use of an investigational product in another research study within 30 days prior to baseline/Visit 2.

Primary outcomes:
measure: To evaluate the safety of 21 days of BioPB-01 administration on
timeFrame: Day 21
measure: To evaluate the safety of 21 days of BioPB-01 administration on
timeFrame: Day 14
measure: To evaluate the safety of 21 days of BioPB-01 administration on
timeFrame: Day 7
measure: To evaluate the safety of 21 days of BioPB-01 administration on
timeFrame: Day 21
measure: To evaluate the safety of 21 days of BioPB-01 administration on
timeFrame: Day 14
measure: To evaluate the safety of 21 days of BioPB-01 administration on
timeFrame: Day 7
measure: To evaluate the safety of 21 days of BioPB-01 administration on
timeFrame: Day 21
measure: To evaluate the safety of 21 days of BioPB-01 administration on
timeFrame: Day 21
measure: To evaluate the safety of 21 days of BioPB-01 administration on
timeFrame: Day 21
measure: To evaluate the safety of 21 days of BioPB-01 administration on
timeFrame: Day 21
measure: To evaluate the safety of 21 days of BioPB-01 administration on
timeFrame: Day 21
measure: To evaluate the safety of 21 days of BioPB-01 administration on
timeFrame: Day 21
measure: To evaluate the safety of 21 days of BioPB-01 administration on
timeFrame: Day 21
measure: To evaluate the safety of 21 days of BioPB-01 administration on
timeFrame: Day 21
measure: To evaluate the safety of 21 days of BioPB-01 administration on
timeFrame: Throughout the study (an average of 21 days)
Secondary outcomes:
measure: To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing the metabolic health
timeFrame: Day 21
measure: To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing
timeFrame: Day 21
measure: To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing
timeFrame: Day 21
measure: To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing
timeFrame: Day 21
measure: To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing
timeFrame: Day 21
measure: To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing
timeFrame: Day 21
measure: To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing Fecal short chain fatty acids (SCFA)
timeFrame: Day 21
Other outcomes:
Locations:
city: Vadodara
country: India
facility: Aman Hospital and Research Center
state: Gujarat
city: Nashik
country: India
facility: Lifecare Hospital
state: Maharashtra
Study officials:
References: