A Clinical Study to Evaluate the Safety and Tolerability of BioPB-01 in Healthy Adults

NCT05839444 | Completed

• 1 other identifier: BT/220901/PM/SAT
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

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

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (15)

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

  The gastrointestinal (GI) health assessed using a modified Gastrointestinal Symptom Questionnaire (GSQ) compared to baseline and placebo

  Day 21

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

  The gastrointestinal (GI) health assessed using a modified Gastrointestinal Symptom Questionnaire (GSQ) compared to baseline and placebo

  Day 14

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

  The gastrointestinal (GI) health assessed using a modified Gastrointestinal Symptom Questionnaire (GSQ) compared to baseline and placebo

  Day 7

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

  Stool consistency using Bristol stool form scale (BSFS) compared to baseline and placebo.This scale is a 7 point ordinal scale of stool types. The participants will be asked to rate their stool consistency and frequency daily to assess abnormal stools, defined as alteration in the frequency or consistency type 1, 2, 6, or 7.

  Day 21

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

  Stool consistency using Bristol stool form scale (BSFS) compared to baseline and placebo. The participants will be asked to rate their stool consistency and frequency daily to assess abnormal stools, defined as alteration in the frequency or consistency type 1, 2, 6, or 7.

  Day 14

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

  Stool consistency using Bristol stool form scale (BSFS) compared to baseline and placebo. The participants will be asked to rate their stool consistency and frequency daily to assess abnormal stools, defined as alteration in the frequency or consistency type 1, 2, 6, or 7.

  Day 7

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

  Liver function biomarkers Alanine transaminase (ALT) Reference range: Females: 9-52 U/L Males: 21-72 U/L

  Day 21

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

  Liver function biomarkers Aspartate aminotransferase (AST) Reference range: Females: 14-36 U/L Males: 17-59 U/L

  Day 21

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

  Renal function biomarker blood urea nitrogen (BUN) - Female: 7-17 mg/dL or 2.5-6.1 mmol/L Male: 9-20 mg/dL or 3.2-7.1 mmol/L

  Day 21

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

  Renal function biomarker Creatinine Reference range: Female: 0.52-1.04 mg/dL or 46-92 μmol/L Male: 0.66-1.25 mg/dL or 58-110 μmol/L

  Day 21

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

  Serum electrolytes (sodium) : 137-145 mmol/L

  Day 21

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

  Serum electrolytes (potassium): 3.5-5.1 mmol/L

  Day 21

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

  Vitals - Blood pressure : Both Systolic and Diastolic pressure will be measured

  Day 21

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

  Vitals - Pulse rate

  Day 21

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

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

  Throughout the study (an average of 21 days)

Secondary Outcomes (7)

• 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

  Day 21

• To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing

  Day 21

• To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing

  Day 21

• To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing

  Day 21

Study Arms (2)

BioPB-01

ACTIVE COMPARATOR

2 sachets/day, one to be taken orally with (4±1 mins prior) at breakfast and one (4±1 mins prior) at dinner.

Other: BioPB-01

Placebo

PLACEBO COMPARATOR

2 sachets/day, one to be taken orally with (4±1 mins prior) at breakfast and one (4±1 mins prior) at dinner.

Other: Placebo

Interventions

BioPB-01 OTHER

2 sachets/day, one to be taken orally with (4±1 mins prior) at breakfast and one (4±1 mins prior) at dinner

BioPB-01

Placebo OTHER

2 sachets/day, one to be taken orally with (4±1 mins prior) at breakfast and one (4±1 mins prior) at dinner

Placebo

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• Currently taking dietary supplements other than vitamins and minerals.
• 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.
• 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.
• Receipt or use of an investigational product in another research study within 30 days prior to baseline/Visit 2.

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead

Study Sites (2)

Aman Hospital and Research Center

Vadodara, Gujarat, 390021, India

Location

Lifecare Hospital

Nashik, Maharashtra, 422009, India

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Stratified block randomization, Sequentially numbered, sealed, opaque envelopes
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized, double-blind, placebo-controlled, parallel-group

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: May 3, 2023
• Study Start: April 27, 2023
• Primary Completion: September 12, 2023
• Study Completion: September 12, 2023
• Last Updated: February 8, 2024

Record last verified: 2024-02

Locations

IN (2)