A study to see the effect of supplement with protein powder for better absorption of amino acids
- Registration Number
- CTRI/2024/01/061065
- Lead Sponsor
- Sanzyme Biologics P Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
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.
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.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Rate of amino acid absorption: To determine the rate (in minutes) of amino acid absorption into the bloodstream after a two-week pattern of whey protein supplementation with and without the addition of Bacillus coagulans SNZ 1969. <br/ ><br> <br/ ><br>2.Extent of amino acid absorption: To determine the extent (concentration in millimoles/Liter) of amino acid absorption into the bloodstream after a two-week pattern of whey protein supplementation with and without the addition of Bacillus coagulans SNZ 1969. <br/ ><br>Timepoint: At the end of 2 weeks of supplementation in Period 1 and period 2 respectively
- Secondary Outcome Measures
Name Time Method To investigate the acne development after a two-week pattern of whey protein supplementation with and without the addition of Bacillus coagulans SNZ 1969.Timepoint: Baseline and end of supplementation for Period I and II respectively