An open label, balanced, randomized, two-arm, two-period, crossover, oral bio-study to determine the effect of MB EnzymePro® Capsule on bioavailability of whey protein in healthy, adult, human male participants under fasting condition.
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Bright Lifecare Pvt. Ltd. (Healthkart)
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- To determine the effect of MB EnzymePro®, capsule on bioavailability of whey protein in healthy human male participants. This study is intended to show the effect of MB EnzymePro® capsule with whey protein as compare to Control Group with whey protein only on the percentage enhancement of amino acid levels i.e. enhancement of bioavailability of protein.
Overview
Brief Summary
This is an open-label, balanced, randomized, two-arm, two-period, crossover, oral bioavailability study designed to determine the effect of MB EnzymePro® Capsule on the bioavailability of whey protein in healthy adult male participants under fasting conditions.
A total of 84 healthy adult males aged 18–35 years will be enrolled. Participants will receive either MB EnzymePro® Capsule (260 mg enzyme blend) administered along with 50 g flavored whey protein (Test) or whey protein alone (Control) in two treatment periods separated by a 5-day washout. The study will be conducted under controlled fasting conditions.
The primary objective is to evaluate the effect of MB EnzymePro® Capsule on the bioavailability of whey protein by comparing changes in plasma amino acid concentrations between the test and control groups. The study also aims to assess whether MB EnzymePro® enhances in-vivo protein absorption and influences nitrogen balance and C-reactive protein (CRP) levels.
The secondary objective is to evaluate the safety and tolerability of MB EnzymePro® Capsule through monitoring of vital signs, ECG, laboratory investigations, and adverse events during the study.
Study Design
- Study Type
- Ba/be
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 35.00 Year(s) (—)
- Sex
- Male
Inclusion Criteria
- •Able to read and understand and ready to provide written informed consent.
- •Healthy adult male human beings within the age of 18 to 35 years.
- •Having A Body Mass Index (BMI) in the range 20.0 to 24.0 kg per m2 and weight at least 50 kg.
- •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.
- •Chest X-ray is normal or considered by the physician or Principal Investigator to be of no clinical significance.
- •Screening laboratory values are within normal limits or considered by the physician or Principal Investigator to be of no clinical significance.
- •Non-weight training participant who agrees not to begin a new exercise program during the course of the study.
Exclusion Criteria
- •Known hypersensitivity or idiosyncratic reaction or intolerance to MB EnzymePro® or 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.
- •Positive Breath Alcohol Analysis or Urine Drug Screen (UDS) before admission in Period-I of the study.
- •Resting hypotension (BP less than 90 to 60) or hypertension (BP more than 139 to 89).
- •Pulse rate below 50 per min.
- •and above 99 per min.
- •Clinically significant abnormal lab values or abnormal ECG and Chest X Ray.
- •Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses, and syphilis.
- •History of Myocardial Infarction, Stroke, Peripheral Arterial Disease, GI Bleeding, Hepatic Impairment, Renal Impairment, Epilepsy and Intracranial hemorrhage.
- •History of known food allergy.
- •History of drug abuse or alcoholism i.e. alcohol consumption more than 2 units per day or 10 units per week (one unit of alcohol 50 ml spirit or 200 ml wine or 500ml beer).
Outcomes
Primary Outcomes
To determine the effect of MB EnzymePro®, capsule on bioavailability of whey protein in healthy human male participants. This study is intended to show the effect of MB EnzymePro® capsule with whey protein as compare to Control Group with whey protein only on the percentage enhancement of amino acid levels i.e. enhancement of bioavailability of protein.
Time Frame: 00.00, 00.25, 00.50, 00.75, 01.00, 01.25, 01.50, 02.00, 03.00 and 04.00 hrs. in both period
Secondary Outcomes
- To evaluate the safety of the product by monitoring vital signs, conducting pre and post treatment laboratory assessments, and(recording any adverse events throughout the study period any gastric discomfort after product administration.)
Investigators
Dr Avinash Andhale
Vivotech Research Lab Pvt. Ltd.