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NCT04785170
Clinical Study to Evaluate Safety and Efficacy of Amino Acid in Healthy Individuals
NA trial testing Amino Acid in Safety and Efficacy in 13 participants. Completed in 26 March 2021.
26 March 2021
Quick facts
| Lead sponsor | Vedic Lifesciences Pvt. Ltd. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 13 |
| Start date | 2 February 2021 |
| Primary completion | 26 March 2021 |
| Estimated completion | 26 March 2021 |
| Sites | 1 location across India |
Drugs / interventions tested
- Amino Acid
Conditions studied
- Safety and Efficacy — all drugs for Safety and Efficacy →
Sponsor
Vedic Lifesciences Pvt. Ltd. — full company profile →
Who can join
Adults 18 to 50, male only, with Safety and Efficacy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04785170
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Amino Acid
Trials testing the same drug.
- NCT05877989 — Evaluation of Effectiveness of Combining High Protein Intake With Early Physical Exercise During Critical Illness · Phase 4 · completed
- NCT03267745 — Effects of Amino Acid Formulation on Healthy Men Undergoing Unilateral Knee Immobilization · NA · completed
Other recruiting trials for Safety and Efficacy
Currently open trials in the same condition.
- NCT06244537 — Study on the Safety and Efficacy of MR-Linac Technique in Patients With Unresectable Locally Advanced Colon Cancer · NA · recruiting
- NCT05349552 — Safety and Efficacy of SBRT in the Treatment of Thoracic Malignant Tumors at Different Sites · recruiting
- NCT05556889 — Safety and Analgesic Efficacy of a Modified Auriculotemporal Nerve Block · NA · recruiting
Other Vedic Lifesciences Pvt. Ltd. trials
Trials by the same sponsor.
- NCT07141368 — Single Oral Dose Comparative Bioavailability Study of Investigational Product in Healthy Human Subjects Under Fasting Co · NA · not yet recruiting
- NCT07033754 — A Study to Assess the Effect Probiotic Supplement on Immune Health in Teachers Prone to Upper Respiratory Tract Infectio · NA · not yet recruiting
- NCT06917287 — A Clinical Study to Evaluate the Efficacy of Native CT-II® in Individuals With Knee Osteoarthritis · NA · recruiting
- NCT06859346 — A Clinical Study to Assess the Effect of Tisina Complex on Cognitive Health in Individuals With Mild Cognitive Impairmen · NA · completed
- NCT06473246 — A Study to Determine Safety, Pharmakokinetics and Efficacy of the Different Doses of VL-SE-01 in Healthy Participants. · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04785170 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Vedic Lifesciences Pvt. Ltd.
- Last refreshed: 14 May 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04785170.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing