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.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Male
入选标准
- •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.
排除标准
- •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).
- •History of smoking or tobacco consumption
- •History of allergy to heparin, preservatives, dyes.
- •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.
- •Suffered with any illness or who have been hospitalized within the last 4 weeks preceding the start of the study.
- •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.
- •Presence of active peptic ulceration or a history of peptic ulceration.
- •History of clinically significant, Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
- •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).
- •Difficulty with donating blood.
- •Difficulty in swallowing of Capsules.
- •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.
结局指标
主要结局
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.
时间窗: 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
次要结局
- 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.)
研究者
Dr Avinash Andhale
Vivotech Research Lab Pvt. Ltd.