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Oleuropein and Muscle Energy Metabolism

NCT05217433 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-03-17

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Maastricht University Medical Center

    collaborator OTHER

  • Société des Produits Nestlé (SPN)

    lead INDUSTRY

Principal Investigators

  • Luc van Loon · Maastricht University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-04
Primary Completion
2023-03-10
Completion
2023-03-10

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05217433 on ClinicalTrials.gov