NCT05217433

Oleuropein and Muscle Energy Metabolism

A Randomized, Double-blind, Placebo Controlled Study to Investigate the Efficacy of Oleuropein on Skeletal Muscle Energy Metabolism and Fatigue in Humans

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: Male
• Age: 50 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Preclinical studies performed at Nestlé Research (NR) identified oleuropein as a novel activator of mitochondrial calcium import. This potentiated mitochondrial calcium uptake resulted in decreased phosphorylation of the enzyme pyruvate dehydrogenase (PDH), which is linked to its activation as a rate limiting enzyme for mitochondrial oxidation, as well as increasing mitochondrial oxygen consumption, resulting ultimately in decreases in muscle fatigue. In addition, NR demonstrated that during aging, mitochondrial calcium and oxygen consumption rates are decreased in isolated skeletal muscle fibers. The next step in the evidence development is to demonstrate efficacy of oleuropein for improved muscle energy and decreased physical fatigue in a healthy aging population.

Conditions

• Muscular Fatigue

Interventions

Type	Name	Description
OTHER	Olive leaf extract	The investigational product is a capsule containing 100mg of the active ingredient oleuropein and will be provided once daily in the form of a 250mg olive leaf extract (i.e. 100mg of oleuropein per day) product for the duration of the intervention period (36 days).
OTHER	Placebo	The control will be a placebo capsule containing 336 mg of cellulose microcrystalline, matching the investigational product appearance.

Timeline

• Start date: 2021-11-04
• Primary completion: 2023-03-10
• Completion: 2023-03-10
• First posted: 2022-02-01
• Last updated: 2023-03-17

Locations

1 site across 1 country: Netherlands