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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 21 |
| To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aman Hospital and Research Center | Vadodara | Gujarat | 390021 | India | ||
| Lifecare Hospital |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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randomized, double-blind, placebo-controlled, parallel-group
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Stratified block randomization, Sequentially numbered, sealed, opaque envelopes
| 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 |
|
| 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) |
The insulin sensitivity as assessed by HOMA-IR from baseline |
| 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. | 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 | 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. | Day 21 |
| To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing | Body weight from baseline. | 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). | Day 21 |
| Nashik |
| Maharashtra |
| 422009 |
| India |
| D009750 |
| Nutritional and Metabolic Diseases |