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

Primary Purpose

Metabolic Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
BioPB-01
Placebo
Sponsored by
Vedic Lifesciences Pvt. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Metabolic Syndrome

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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. 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.

Sites / Locations

  • Aman Hospital and Research CenterRecruiting
  • Lifecare HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

BioPB-01

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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
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
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.
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.
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.
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
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
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
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
To evaluate the safety of 21 days of BioPB-01 administration on
Serum electrolytes (sodium) : 137-145 mmol/L
To evaluate the safety of 21 days of BioPB-01 administration on
Serum electrolytes (potassium): 3.5-5.1 mmol/L
To evaluate the safety of 21 days of BioPB-01 administration on
Vitals - Blood pressure : Both Systolic and Diastolic pressure will be measured
To evaluate the safety of 21 days of BioPB-01 administration on
Vitals - Pulse rate
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)

Secondary Outcome Measures

To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing the metabolic health
As assessed by the serum lipid profile (Triglycerides (TG), Total cholesterol (TC), low-density lipoprotein (LDL), and high-density lipoprotein (HDL)) level from Baseline
To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing
The insulin sensitivity as assessed by HOMA-IR from baseline
To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing
The post-prandial insulin response by net incremental area-under-the-curve (AUC) for post-prandial glucose and insulin (30, 60, 90, and 120 min. after standardised meal) from baseline.
To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing
Inflammation by serum C-reactive protein (CRP) level from Baseline
To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing
Satiety using the Appetite/Satiety - using Visual Analog Scale (VAS) from Baseline. The scale comprises of 4 main domains: 1) Hunger, 2) Fullness after meals, 3) Thoughts of food, 4) Cravings. The appetite will be analysed based on these four domains on a 100 mm VAS. Reduction in scores as compared to day 0 and placebo will indicate improvement in the appetite/satiety and efficacy of the IP on the appetite/satiety.
To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing
Body weight from baseline.
To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing Fecal short chain fatty acids (SCFA)
Namely acetate, propionate, and butyrate from Baseline. The samples will be analysed using liquid chromatography tandem mass spectrometry (LC-MS/MS).

Full Information

First Posted
March 23, 2023
Last Updated
September 4, 2023
Sponsor
Vedic Lifesciences Pvt. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05839444
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 27, 2023 (Actual)
Primary Completion Date
September 7, 2023 (Anticipated)
Study Completion Date
November 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vedic Lifesciences Pvt. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized, double-blind, placebo-controlled, parallel-group
Masking
ParticipantCare ProviderInvestigator
Masking Description
Stratified block randomization, Sequentially numbered, sealed, opaque envelopes
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BioPB-01
Arm Type
Active Comparator
Arm Description
2 sachets/day, one to be taken orally with (4±1 mins prior) at breakfast and one (4±1 mins prior) at dinner.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
2 sachets/day, one to be taken orally with (4±1 mins prior) at breakfast and one (4±1 mins prior) at dinner.
Intervention Type
Other
Intervention Name(s)
BioPB-01
Intervention Description
2 sachets/day, one to be taken orally with (4±1 mins prior) at breakfast and one (4±1 mins prior) at dinner
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
2 sachets/day, one to be taken orally with (4±1 mins prior) at breakfast and one (4±1 mins prior) at dinner
Primary Outcome Measure Information:
Title
To evaluate the safety of 21 days of BioPB-01 administration on
Description
The gastrointestinal (GI) health assessed using a modified Gastrointestinal Symptom Questionnaire (GSQ) compared to baseline and placebo
Time Frame
Day 21
Title
To evaluate the safety of 21 days of BioPB-01 administration on
Description
The gastrointestinal (GI) health assessed using a modified Gastrointestinal Symptom Questionnaire (GSQ) compared to baseline and placebo
Time Frame
Day 14
Title
To evaluate the safety of 21 days of BioPB-01 administration on
Description
The gastrointestinal (GI) health assessed using a modified Gastrointestinal Symptom Questionnaire (GSQ) compared to baseline and placebo
Time Frame
Day 7
Title
To evaluate the safety of 21 days of BioPB-01 administration on
Description
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.
Time Frame
Day 21
Title
To evaluate the safety of 21 days of BioPB-01 administration on
Description
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.
Time Frame
Day 14
Title
To evaluate the safety of 21 days of BioPB-01 administration on
Description
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.
Time Frame
Day 7
Title
To evaluate the safety of 21 days of BioPB-01 administration on
Description
Liver function biomarkers Alanine transaminase (ALT) Reference range: Females: 9-52 U/L Males: 21-72 U/L
Time Frame
Day 21
Title
To evaluate the safety of 21 days of BioPB-01 administration on
Description
Liver function biomarkers Aspartate aminotransferase (AST) Reference range: Females: 14-36 U/L Males: 17-59 U/L
Time Frame
Day 21
Title
To evaluate the safety of 21 days of BioPB-01 administration on
Description
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
Time Frame
Day 21
Title
To evaluate the safety of 21 days of BioPB-01 administration on
Description
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
Time Frame
Day 21
Title
To evaluate the safety of 21 days of BioPB-01 administration on
Description
Serum electrolytes (sodium) : 137-145 mmol/L
Time Frame
Day 21
Title
To evaluate the safety of 21 days of BioPB-01 administration on
Description
Serum electrolytes (potassium): 3.5-5.1 mmol/L
Time Frame
Day 21
Title
To evaluate the safety of 21 days of BioPB-01 administration on
Description
Vitals - Blood pressure : Both Systolic and Diastolic pressure will be measured
Time Frame
Day 21
Title
To evaluate the safety of 21 days of BioPB-01 administration on
Description
Vitals - Pulse rate
Time Frame
Day 21
Title
To evaluate the safety of 21 days of BioPB-01 administration on
Description
The number and percentage of participants having adverse product reaction (as per CTCAE V5.0)
Time Frame
Throughout the study (an average of 21 days)
Secondary Outcome Measure Information:
Title
To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing the metabolic health
Description
As assessed by the serum lipid profile (Triglycerides (TG), Total cholesterol (TC), low-density lipoprotein (LDL), and high-density lipoprotein (HDL)) level from Baseline
Time Frame
Day 21
Title
To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing
Description
The insulin sensitivity as assessed by HOMA-IR from baseline
Time Frame
Day 21
Title
To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing
Description
The post-prandial insulin response by net incremental area-under-the-curve (AUC) for post-prandial glucose and insulin (30, 60, 90, and 120 min. after standardised meal) from baseline.
Time Frame
Day 21
Title
To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing
Description
Inflammation by serum C-reactive protein (CRP) level from Baseline
Time Frame
Day 21
Title
To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing
Description
Satiety using the Appetite/Satiety - using Visual Analog Scale (VAS) from Baseline. The scale comprises of 4 main domains: 1) Hunger, 2) Fullness after meals, 3) Thoughts of food, 4) Cravings. The appetite will be analysed based on these four domains on a 100 mm VAS. Reduction in scores as compared to day 0 and placebo will indicate improvement in the appetite/satiety and efficacy of the IP on the appetite/satiety.
Time Frame
Day 21
Title
To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing
Description
Body weight from baseline.
Time Frame
Day 21
Title
To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing Fecal short chain fatty acids (SCFA)
Description
Namely acetate, propionate, and butyrate from Baseline. The samples will be analysed using liquid chromatography tandem mass spectrometry (LC-MS/MS).
Time Frame
Day 21

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Shalini Srivastava, MBBS, MD
Phone
02242172300
Email
shalini.s@vediclifesciences.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Sonal Raote, BAMS
Phone
02242172325
Email
sonal.raote@vediclifesciences.com
Facility Information:
Facility Name
Aman Hospital and Research Center
City
Vadodara
State/Province
Gujarat
ZIP/Postal Code
390021
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Aman Khanna, MBBS, MD (Medicine)
Phone
9904402122
Email
amankhanna1974@gmail.com
Facility Name
Lifecare Hospital
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422009
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Sandeep Gaidhani, MBBS, MD (Medicine)
Phone
7588606598
Email
drsandeepgaidhani@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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