A pilot randomized, double-blind, placebo-controlled, parallel-group clinical study to study the safety and tolerability of IP in healthy adults
- Registration Number
- CTRI/2023/03/050853
- Lead Sponsor
- Vedic Lifesciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 64
1. Participants who are 25 to 55 years of age (inclusive) at the time of signing 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.
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, current COVID-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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.Timepoint: 21 days of BioPB-01 compared to baseline and placebo.
- Secondary Outcome Measures
Name Time Method