A study to test the effect of Pepzyme Pro on the digestion and absorption of Pea protei
- Registration Number
- CTRI/2021/10/037072
- Lead Sponsor
- Advanced Enzymes Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. Adult Indian male or female with age 18 to 35 years [both inclusive] at the time of signing informed consent.
2. Normal body weight (body mass index (BMI) of 19ââ?¬â??24.99 kg/m2)
3. Willingness to provide written informed consent and comply with study instructions for its duration and agree not to participate in other clinical studies within 30 days after the last administration from the first administration of the study drug.
4. Must be of normal health as determined by medical history and physical examination within 28 days prior to the commencement of the study.
5. Screening laboratory values are within normal limits or considered by the physician / Principal Investigator to be of no clinical significance.
The subjects will be excluded based on the following criteria during screening and during the study.
1. Any individual who was treated or diagnosed with a gastrointestinal, cardiac, respiratory, circulatory, musculoskeletal, metabolic, immune, autoimmune, psychiatric, hematological, neurological, or endocrinological disorder
2. Participants who were determined to not be weight stable defined as measured body mass deviating by 5%
3. Participants who were not willing to abstain from alcohol, nicotine, and caffeine for 12 h prior to each visit
4. Subject s who have received organ transplantation or surgery in the past 6 months
5. Known hypersensitivity or idiosyncratic reaction or intolerance to Pepzyme Pro /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.
6. Women subjects that are pregnant or lactating, or subjects (including male subjects) having a pregnancy plan (including plans for sperm donation or egg donation) during the study period
7. Allergic to enzyme supplements
8. Subject s who have participated in any other clinical study within 2 weeks prior to randomization
9. The investigators conclude that the Subject is not suitable for the study.
10. History of smoking or Tobacco consumption
11. Intake or administered protein supplements, enzyme 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.
12. History of clinically significant, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
13. Difficulty with donating blood.
14. 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 1.Change in plasma free amino acids within 4h of consumption of protein in control arm and test arm and pairwise comparison between both the armsTimepoint: 0, 30 min, 1h, 2 h, 3h, and 4h; using suitable statistical method
- Secondary Outcome Measures
Name Time Method 1.Assessment of treatment emergent adverse events <br/ ><br>2.Change in nitrogen level in fecal sample and urine sample <br/ ><br>3.Change in serum Insulin and CRP level <br/ ><br>4.Assessment of bloating using questionnaire <br/ ><br>5.Change in gut microbiome in fecal sampleTimepoint: Frequency and percentage of AEs and count of AEs will be presented as summary statistics. <br/ ><br>� Time frame: from Baseline to EOT or Day 45, as applicable <br/ ><br>The vital sign parameters will be summarized descriptively at each visit. Change in vital sign parameters from Baseline will be summarized and tested through paired t-test.