A study to determine the effect of MB EnzymeProTM capsule in enhancing the absorption of whey protein in healthy human male subjects.
- Registration Number
- CTRI/2019/02/017731
- Lead Sponsor
- Bright Lifecare Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
1.Able to read and understand and ready to provide written informed consent.
2. Healthy adult male human beings within the age of 18-35 years (both inclusive).
3. Having A Body Mass Index (BMI) in the range 20.0 - 24.0 kg/m2 (both inclusive) and weight at least 50 kg.
4. Must be of normal health as determined by medical history and physical examination, ECG and laboratory tests performed within 28 days prior to the commencement of the study.
5. Chest X-ray is normal or considered by the physician / Principal Investigator to be of no clinical significance.
6. Screening laboratory values are within normal limits or considered by the physician / Principal Investigator to be of no clinical significance.
7. Non-weight training subject who agree not to begin a new exercise program during the course of the study
1.Known hypersensitivity or idiosyncratic reaction or intolerance to MB EnzymePro /Protein diet or any ingredients of the formulation or any related products as well as severe hypersensitivity reactions (like angioedema) to any drugs or food products.
2.Positive Breath Alcohol Analysis or Urine Drug Screen (UDS) before admission in Period-I of the study.
3.Resting hypotension (BP less than 90/60) or hypertension (BP greater than 139 /89).
4.Pulse rate below 50/ min. and above 99/min.
5.Clinically significant abnormal lab values / abnormal ECG and Chest X-Ray.
6.Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses, and syphilis.
7.History of Myocardial Infarction, Stroke, Peripheral Arterial Disease, GI Bleeding, Hepatic-Impairment, Renal Impairment, Epilepsy and Intracranial hemorrhage.
8.History of known food allergy.
9.History of drug abuse or alcoholism i.e. alcohol consumption greater than 2 units / day or 10 units / week (one unit of alcohol equal to 50 ml spirit or 200 ml wine or 500ml beer).
10.History of smoking or Tobacco consumption
11.History of allergy to heparin, preservatives, dyes.
12.Intake or administered protein supplements or any drugs or over the counter or prescribed medications including any enzyme modifying drugs within the last 14 days prior to the study drug administration in the study.
13.Suffered with any illness or who have been hospitalized within the last 4 weeks preceding the start of the study.
14.History or presence of significant gastrointestinal, liver or kidney disease, or any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects.
15.Presence of active peptic ulceration or a history of peptic ulceration.
16.History of clinically significant, Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
17.Participated in any other clinical trial requiring repeated blood sampling or a blood donation program or blood loss of more than 350 ml, in the past three months (approx. 90 days) (This 350 mL includes the total blood loss that will occur during the study).
18.Difficulty with donating blood.
19.Difficulty in swallowing of Tablet and Capsules.
20.Following any particular protein-rich dietary regime, muscle toning or body building program or not willing to discontinue such regime or program during the conduct of study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate the effect of test products in terms of comparison in AUC of test products i.e. treatment groups and control group for determination of amino acid (AA) concentrationTimepoint: Baseline Pre-dose (30±10 minute prior to <br/ ><br>dosing) and at 00.25, 00.50, 00.75, 01.00, 01.25, <br/ ><br>01.50, 02.00, 03.00, 04.00 hours post-dose.
- Secondary Outcome Measures
Name Time Method To evaluate the amount of nitrogen excreted in 24 hours after test product i.e. treatment groups and control group consumption.Timepoint: 24 hours post dose;To evaluate the effect of test products i.e. treatment groups and control group on total sum of individual amino acid level (TSAA)and Individual <br/ ><br>amino acids (IAA)Timepoint: baseline Pre-dose (30±10 minute prior to dosing) and at 00.25, 00.50, 00.75, 01.00, 01.25, 01.50, 02.00, 03.00 and 04.00 hours post-dose;To evaluate the safety of Test products i.e. treatment groups and control group on serum inflammatory marker C-reactive protein (CRP)Timepoint: baseline Pre-dose (30±10 minute prior to dosing) and at 04.00 hours post-dose.