Metabolic SyndromeNCT05839444
A Clinical Study to Evaluate the Safety and Tolerability of BioPB-01 in Healthy Adults
A study testing BioPB-01 in people with Metabolic Syndrome, run by Vedic Lifesciences Pvt. Ltd. at 2 sites in India.
Trial 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 Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- BioPB-01
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 2 sitesIndia
- Study dates
- 27 Apr 2023to 12 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
India2 sites
Lifecare Hospital
Nashik, Maharashtra, 422009
Aman Hospital and Research Center
Vadodara, Gujarat, 390021
About this study
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
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
- Being tested
- BioPB-01, Placebo
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioPB-01Other
2 sachets/day, one to be taken orally with (4±1 mins prior) at breakfast and one (4±1 mins prior) at dinner
PlaceboOther
2 sachets/day, one to be taken orally with (4±1 mins prior) at breakfast and one (4±1 mins prior) at dinner
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 21
To evaluate the safety of 21 days of BioPB-01 administration on
Serum electrolytes (sodium) : 137-145 mmol/L
Measured: Day 21
To evaluate the safety of 21 days of BioPB-01 administration on
Serum electrolytes (potassium): 3.5-5.1 mmol/L
Measured: 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
Measured: Day 21
To evaluate the safety of 21 days of BioPB-01 administration on
Vitals - Pulse rate
Measured: 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)
Measured: 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
As assessed by the serum lipid profile (Triglycerides (TG), Total cholesterol (TC), low-density lipoprotein (LDL), and high-density lipoprotein (HDL)) level from Baseline
Measured: Day 21
To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing
The insulin sensitivity as assessed by HOMA-IR from baseline
Measured: Day 21
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.
Measured: Day 21
To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing
Inflammation by serum C-reactive protein (CRP) level from Baseline
Measured: Day 21
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.
Measured: Day 21
To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing
Body weight from baseline.
Measured: Day 21
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).
Measured: Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start27 Apr 2023
- Primary completion12 Sep 2023
- Study completion12 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, double-blind, placebo-controlled, parallel-group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839444
- Sponsor's protocol ID
- BT/220901/PM/SAT
- Status last verified
- Feb 2024
- First submitted
- 23 Mar 2023
- Last updated
- 8 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05839444
- Acronym / sponsor ID
- BT/220901/PM/SAT
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- 12 Sep 2023 (actual)
- Study completion
- 12 Sep 2023 (actual)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- randomized, double-blind, placebo-controlled, parallel-group
| Arm | Type | Receives |
|---|---|---|
| BioPB-01 | Active comparator | Other: BioPB-012 sachets/day, one to be taken orally with (4±1 mins prior) at breakfast and one (4±1 mins prior) at dinner. |
| Placebo | Placebo comparator | Other: Placebo2 sachets/day, one to be taken orally with (4±1 mins prior) at breakfast and one (4±1 mins prior) at dinner. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioPB-012 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 |
| Placebo2 sachets/day, one to be taken orally with (4±1 mins prior) at breakfast and one (4±1 mins prior) at dinner | Other | Placebo |
Primary outcome
To evaluate the safety of 21 days of BioPB-01 administration on
Time frame: Day 21
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
Time frame: Day 14
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
Time frame: Day 7
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
Time frame: Day 21
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
Time frame: Day 14
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
Time frame: Day 7
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
Time frame: Day 21
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
Time frame: Day 21
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
Time frame: Day 21
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
Time frame: Day 21
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
Time frame: Day 21
Serum electrolytes (sodium) : 137-145 mmol/L
To evaluate the safety of 21 days of BioPB-01 administration on
Time frame: Day 21
Serum electrolytes (potassium): 3.5-5.1 mmol/L
To evaluate the safety of 21 days of BioPB-01 administration on
Time frame: Day 21
Vitals - Blood pressure : Both Systolic and Diastolic pressure will be measured
To evaluate the safety of 21 days of BioPB-01 administration on
Time frame: Day 21
Vitals - Pulse rate
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)
7 secondary outcomes
To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing the metabolic health
Time frame: Day 21
To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing
Time frame: Day 21
To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing
Time frame: Day 21
To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing
Time frame: Day 21
To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing
Time frame: Day 21
To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing
Time frame: Day 21
To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing Fecal short chain fatty acids (SCFA)
Time frame: Day 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Metabolic Syndrome
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioPB-01 in people with Metabolic Syndrome, run by Vedic Lifesciences Pvt. Ltd. at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety of 21 days of BioPB-01 administration on (time frame: Day 21). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.