A randomized, double blind, cross over study to evaluate the amino acid absorption after the intake of whey protein along with probioticBacillus coagulans SNZ 1969 in normal, healthy, adult, human subjects. - Nil

Sanzyme Biologics P Ltd0 sites30 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

June 3, 2024

Last Updated

last year

Study Type

Ba/be

Sponsor

Sanzyme Biologics P Ltd

•1\.Healthy human subjects between 18\-30 years of age (including both) and weight and BMI 18\.5 to 30\.0 kg/m² (including both) with body fat \<30%.
•2\.Acceptable findings during registration and screening including, medical history, physical examination, laboratory evaluations, 12\- lead ECG and Chest X\-Ray (postero\-anterior view).
•3\.Non\-smokers and Non\-alcoholics.
•4\.Completing at least 30 minutes of moderate exercise three days per week.
•5\.Values within normal ranges of laboratory parameters upon evaluation by the Investigator or Physician for any of the following tests.
•6\.Subjects able to communicate effectively.
•7\.Subjects willing to give written informed consent and adhere to all the requirements of this protocol.
•8\.Subject willing to abstain from all kinds of caffeine/xanthine containing foods or grapefruit or grapefruit juice from 72\.00 hours prior to visit until the last post dose blood sample collection in each supplementation period.
•9\.Female subjects:
•Postmenopausal for at least 1 year or

•1\.Volunteers having history of contraindication or hypersensitivity (e.g., anaphylaxis) to whey protein products.
•2\.A history of asthma, urticaria, or other allergic\-type reactions after taking aspirin or other NSAIDs.
•3\.A history of seizures, diabetes, migraine, hypertension, cardiovascular, pulmonary, neurological or psychiatric disease/disorder, dermatological, endocrine, eye disorders, immunological, hepatic, renal, hematopoietic, metabolic, gastrointestinal, ongoing infectious diseases, or any other significant abnormality as evidenced by medical history and physical examination or according to the opinion of the physician.
•4\.History or presence of gastrointestinal (GI) inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine.
•5\.History or evidence of exfoliative dermatitis, Stevens \- Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN).
•6\.Any known enzyme inducing or inhibiting drug taken within 30 days before the study.
•7\.Participants who are determined to not be weight stable defined as measured BMI deviating by 2% or more.
•8\.Participation in a drug research study within 90 days prior to intake of first supplementation.
•9\.Blood loss or whole blood donation within 90 days prior to intake of first supplementation.
•10\.Consumption of high caffeine (more than 5 cups of coffee or tea/day).

Not specified