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 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年8月19日

试验速览

阶段: Unknown
状态: 已完成
发起方
入组人数: 30

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

入选标准

•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
•Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed on the subject) or
•Female of childbearing potential practicing an acceptable method of birth control for the duration of the study at least two weeks thereafter as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, and intrauterine device (IUD) or abstinence.

排除标准

•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).
•11.History of addiction to any recreational drug or drug dependence.
•12.An unusual or abnormal diet, for whatever reason within 48.00 hours prior to visit of each supplementation period, e.g., fasting due to religious reasons.
•13.History of dehydration from diarrhea, vomiting or any other reason within a period of 72.00 hours prior to intake of first supplementation
•14.Positive results for drugs of abuse (benzodiazepines, cocaine, opioids, amphetamines, cannabinoids and barbiturates) in urine during the each visit of the study.
•15.Positive results for alcohol consumption tests during the study admission of each visit.
•16.History of pre-existing bleeding disorder.
•17.Difficulty with donating blood.
•18.Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg.
•19.Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
•20.Pulse rate less than 60 beats/minute or more than 100 beats/minute.
•21.Use of any prescribed medication or OTC medicinal products including vitamins and herbal medicinal products during last two weeks preceding the first dosing.
•22.Participants who do not or are not willing to abstain from exercise for 12.00 hours prior to each visit.
•23.Female volunteer who is pregnant, currently breast-feeding.
•24.Female subjects demonstrating a positive pregnancy test.
•25.Female volunteer who has used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 14 days before first dosing.

研究者

发起方

Sanzyme Biologics P Ltd

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