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NCT03197402
Leucine-enriched Nutraceutical and Attenuating Muscle Loss
NA trial testing Leucine-enriched protein gel delivery system in Muscle Loss in 20 participants. Completed in 1 March 2019.
30 November 2018
Quick facts
| Lead sponsor | McMaster University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 9 May 2018 |
| Primary completion | 30 November 2018 |
| Estimated completion | 1 March 2019 |
| Sites | 4 locations across Canada |
Drugs / interventions tested
- Leucine-enriched protein gel delivery system
- Milk protein gel delivery system
Conditions studied
- Muscle Loss — all drugs for Muscle Loss →
Sponsor
McMaster University
Who can join
Adults 70 to 75, female only, with Muscle Loss. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This leucine-enriched protein gummy (as a gummy bar/slab) will be studied to address age-related loss of muscle mass and strength/function in older persons. The product is small volume (approximately 35 g per serve) and low energy (approximately 100 kcal per serve). It is easy to chew and swallow with the consistency of a firm Jello. In addition, it contains an effective dose of leucine in a high-quality protein matrix consisting of milk proteins. Understanding the efficacy of this product on changes in levels of blood amino acids and the molecular signaling required to enhance muscle growth will provide helpful insight for the suggestion of supplemental use.
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 NCT03197402
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT03197402 (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 McMaster University
- Last refreshed: 18 June 2019
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/NCT03197402.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing