Clinical Study to Evaluate Safety and Efficacy of Amino Acid in Healthy Individuals

• Status: Completed
• Trial end date: 2021-03-26
• Target enrollment: 0
• Participant gender: Male

Summary

In summary, all evidence points in the direction that amino acid supplementation is justified for augmenting desired fat loss associated with physical exercise as an obesity therapy. Nonetheless, the present clinical data concerning oral use of amino acid is insufficient for justifying its usage in humans as questions could arise with regards to its safety. Therefore, the present study was proposed to establish the safety profile of amino acid for human use by evaluating its use at a dose of 1000 mg per day in healthy individuals. The occurrence of adverse events will be monitored and reported as per the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0), whereas the cardiac safety will be assessed by changes in electrocardiogram parameters, blood pressure, and heart rate. Furthermore, the effect of amino acid consumption on lipid profile will also be assessed by measuring peripheral levels of leptin, adiponectin, total cholesterol, and triglycerides in healthy individuals.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vedic Lifesciences Pvt. Ltd.

Criteria

Inclusion Criteria:

1. Males aged ≥ 18 and ≤ 50 years.

2. Participants with a BMI within the range of ≥ 18.5 kg/m2 to ≤ 29.9 kg/m2

3. Participants deemed healthy by the investigator.

4. Participants willing to abstain from taking any medications that would interfere with outcomes of the study, i.e. lipid lowering medications, gastrointestinal medications, antibiotics, anti-inflammatory drugs, dietary supplements including fiber supplements, prebiotics and probiotics, etc.

5. Able to comply and perform the procedures requested by the protocol (including dietary restrictions, consumption of study treatments, blood sample collection procedures and study visit schedule)

6. Participants who are literate enough to understand the essence of study, are informed about the purpose of the study, and understand their rights.

7. Participants who are able to give written informed consent.

Exclusion Criteria:

1. Presence of type II diabetes mellitus (Indicated by FBS ≥126 mg/dL, with or without drugs)

2. Presence of hypertension (Defined as SBP ≥ 140 mm Hg and/or DBP ≥ 90 mm Hg, with or without drugs)

3. Participants with deranged CMP of severity ≥ grade II as per CTCAE v5.0.

4. Participants with deranged CBC of severity ≥ grade II as per CTCAE v5.0.

5. Participants with ESR < 2 mm/hr or > 15 mm/hr.

6. Participants with heavy alcohol consumption, defined as:

• For men: More than 14 standard alcoholic drink (SAD)/week or more than 4 SAD in a day.

(NOTE - A standard alcoholic drink contains approximately 14 grams of alcohol, which is equivalent to 12 ounces of beer (~5% alcohol), 8.5 ounces of malt liquor (~9% alcohol), 5 ounces of wine (~12% alcohol), 3.5 ounces of fortified wine (e.g., sherry or port), or 1.5 ounces of liquor (distilled spirits; ~40% alcohol).

7. Binge drinkers, defined as 5 or more SAD for men, in a 2-hour time frame.

8. Individuals having a history (in past 2 years) of smoking or currently smoking or using any form of smokeless tobacco.

9. Consumption of nicotine, alcohol, coffee, and vigorous physical activity within 48 hours prior to all pre-determined assessment visits.

10. Abnormal Thyroid Stimulating Hormone (TSH) value which is < 0.35 or > 4.94 µIU/mL.

11. Evidence of any infection or inflammatory condition at screening.

12. Participants who have clinically active state of systemic illness which includes but is not limited to cardiovascular, endocrine, immune, respiratory, hepatobiliary, kidney and genitourinary, neuropsychiatric, and gastrointestinal system.

13. Participants diagnosed with any malignancy.

14. Participants having tumors that are being treated or planned for surgery.

15. Participants taking medicines (Prescription, OTC, etc), health functional foods or herbal medicines related to weight reduction within 1 month prior to screening.

16. Participant with significant medication use (inhaled beta agonists, central alpha agonists, hormonal contraceptives, corticosteroid use within three months prior to screening).

17. Participants who participated in another human trial within last 30 days prior to screening.

18. Any condition that could, in the opinion of the investigator, preclude the participant's ability to successfully and safely complete the study or that may confound study outcomes.