CTRI/2025/08/093909尚未招募不适用
An open label, randomized, balanced, two-treatment, two-period, two-sequence, single-dose, two-way cross-over, oral, bioavailability study of Protein Supplement- Nutrabay BioAbsorb Whey, manufactured by Fermentis Life Sciences Pvt. Ltd. in comparison with Whey Protein in healthy, adult, human subjects under fasting condition.
Nutrabay Retail Pvt. Ltd.1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年9月9日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To determine the comparative bioavailability of test product as compare to control product (protein supplement) in healthy male subjects. This study is intended to compare the % 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, randomized, balanced, two-treatment, two-period, two-sequence, crossover, oral, single-dose bioavailability study designed to assess and compare the bioavailability of two protein supplements in healthy adult male human volunteers under fasting conditions. The primary objective of this study is to determine the comparative bioavailability of the test product — Nutrabay BioAbsorb Whey — in comparison to the reference product — Whey Protein — by evaluating the serum levels of specific amino acids.
In this study, each subject will receive both the test product (T) and the reference product (R) in two different periods, separated by an adequate washout period to avoid carryover effects. Each product will be administered as a single oral dose of 36 grams of powder reconstituted in 240 ± 02 mL of water. The administration will be conducted under fasting conditions to eliminate the influence of food on absorption and to ensure uniformity in metabolic response.
The bioavailability will be evaluated by measuring the concentrations of 10 amino acids in the serum post-administration. The selected amino acids for analysis include: Alanine, Arginine, Citrulline, Glycine, Leucine, Methionine, Ornithine, Phenylalanine, Tyrosine, and Valine. These are key amino acids that reflect the absorption and metabolism of dietary proteins.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Normal healthy adult human subject (Male and non-pregnant, non lactating female) aged between of 18 to 45 years.
- •Body weight not less than 50 kg for males and not less than 45 kg in case of females.
- •Normal BMI 18.50 to 24.99 kg per m2 (both inclusive)
- •Willingness to provide written Informed Consent to participate in the study.
- •Subjects willing to adhere to the protocol requirements as evidenced by written informed consent approved by ethics committee.
- •Volunteer is able to communicate well with the investigator.
- •Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidence by written informed consent.
- •Subject must be in good health as determined by medical history, vital signs (blood pressure, body temperature, pulse rate, respiratory rate) and physical examination or showing no clinically significant abnormalities in the opinion of Principal or Clinical Investigator or designated physicians.
- •Normal or clinically non significant result of 12 lead ECG of the subjects.
- •Subject having clinical laboratory tests (Biochemistry, Hematology, and Urinalysis and Serology) results within normal reference range or evaluated as non-clinically significant by the investigator or physician.
- •Subject found negative in Breath alcohol test.
- •Subjects that can provide adequate evidence of their identity.
- •Ability to fast for at least 10.00 hours and consume standard meal.
- •Volunteers is non alcoholic and non smoker.
- •The subject willing to abstain from food and drinks, which may interact with circulatory, gastrointestinal, hepatic or renal function (e.g. alcoholic drinks or certain fruit juices such as grapefruit juice) for 72.00 hours prior to the check in of period I to throughout the study.
- •Ability and willingness to abstain from methyl xanthine-containing beverages or food (coffee, tea, coke, chocolate, power drinks) and grapefruit juice from 72.00 hrs.
- •Prior to admission of period I to throughout the study.
- •A negative urine screen result for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine and morphine).
- •Subjects willing to not participate in any clinical research study and or blood donations till 180 days after completion of the study and during the study.
- •Female subjects: • 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 as judged by the investigator(s), such as condoms, foams; jellies, diaphragm, and intrauterine device (IUD) or abstinence.
- •• Female subject must have a negative hCG pregnancy test prior to check in of each period.
- •Male Participants: • Male agreeing to use appropriate contraceptive measures like Double Barrier method (condom + diaphragm, condom or diaphragm + spermicidal gel or foam), and should not donate sperm etc.
排除标准
- •History of Hypersensitivity or intolerance of Protein Supplement.
- •Difficulty in swallowing the powder.
- •Anemia with hemoglobin less than 8 g per dL
- •Body Temperature less than 95.0 °F or above 98.6°F
- •Radial Pulse rate less than 60 per min or above 100 per min
- •Those with a past or existing history of the following diseases or chronic or severe illnesses, including but not limited to the cardiovascular system, digestive system, urogenital system, respiratory system, blood system, endocrine system, immune system, mental nervous system, skeletal system, etc., that researchers believe are still clinically significant; Especially for subjects with gastrointestinal dysfunction, peptic ulcer, gastrointestinal surgery, and other diseases that affect Product absorption, distribution, metabolism, and excretion.
- •Ingestion of a medicine at any time within 14 days before dosing in Period I.
- •In any such case subject selection will be at the discretion of the PI or CI and medicine taken will be recorded.
- •Any history or presence of asthma (including aspirin induced asthma) or NSAID induced urticarial.
- •History or presence of thyroid disease, adrenal dysfunction, organic intracranial lesion.
- •History or presence of cancer.
- •People with positive results of any test for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody.
- •A recent history of alcoholism (120 mL or more per day) and consumption of alcohol within 24 hours prior to receiving study Product.
- •History or presence of significant smoking (09 or more than 09 cigarettes or beedis per day) or could not abstain from smoking during study
- •Maintenance therapy with any drug.
- •Incapable of understanding the informed consent information.
- •(Poor mental development or impaired cerebral function).
- •Subjects who have participated in another clinical study in the past 03 months prior to commencement of this study.
- •Participation in a drug research study within 90 days of screening.
- •Difficulty with donating blood.
- •Donation of blood or Plasma (01 unit: 350 mL or 450 mL) within 90 days for male and female prior to receiving the first dose of study product.
- •prior to product administration and for at least 04.00 hr.
- •after product administration in each period.
- •Refuse to abstain from fluid for at least 01.00 hr.
- •after product administration
- •Abnormal diet pattern for whatever reason (e.g. low sodium, fasting, and high protein diets) during the four weeks preceding the study.
- •Subject consumed tobacco or tobacco containing products, pan or pan masala, gutkha, masala (containing beetle nut and tobacco) for at least 48.00 hours prior to initiation of the study and throughout the study.
- •Subject consumed caffeine and or xanthine-containing foods or beverages (i.e. coffee, tea, chocolate, and caffeine containing sodas, colas, etc.) and grape fruit juice and poppy containing foods for at least 48.00 hours prior to initiation of the study and throughout the study
- •Major illness during the 90 days before screening
- •Found positive in Urine scan for drugs of abuse (Cannabinoids CANNAB, Amphetamine AMP, Barbiturates-BAR, Cocaine COC, Benzodiazepines BZD and Morphine MOR) performed on the day of check in.
- •Found positive in Breath Alcohol test performed on the day of check in.
- •Use of enzyme modifying drugs within 30 days prior to receiving the first dose of study medication.
- •Use of any prescribed medication (including herbal remedies and vitamins) during the two weeks before the start of the study or OTC medicinal products (including herbal remedies and vitamins) during one week prior to study initiation and throughout the study
- •Female subjects demonstrating a positive pregnancy screen.
- •Female volunteer who has used implanted or injected hormonal contraceptives anytime during the 06 months prior to study or used hormonal contraceptives within 07 days before dosing.
结局指标
主要结局
To determine the comparative bioavailability of test product as compare to control product (protein supplement) in healthy male subjects. This study is intended to compare the % enhancement of amino acid levels i.e. enhancement of bioavailability of protein.
时间窗: Predose 00.00 hours and Post dose 01.00, 02.00, 03.00 and 4.00 hrs in both study period.
次要结局
- Safety of the study subjects will also be monitored and evaluated.(Sitting blood pressure, pulse rate, respiratory rate, and body surface)
研究者
Dr Avinash Andhale
Vivotech Research Lab Pvt. Ltd.
研究点 (1)
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