Oleuropein and Muscle Energy Metabolism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-04

Study Completion Date

2023-03-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Muscular Fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a single-centre, double-blind, placebo controlled, randomised 2-arms parallel group study.

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

This is a single-centre, double-blind, placebo controlled, randomised 2-arms parallel group study.

Study Groups

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Investigational product

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).

Group Type EXPERIMENTAL

Olive leaf extract

Intervention Type OTHER

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).

Control arm

The control will be a placebo capsule containing 336 mg of cellulose microcrystalline, matching the investigational product appearance.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

The control will be a placebo capsule containing 336 mg of cellulose microcrystalline, matching the investigational product appearance.

Interventions

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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).

Intervention Type OTHER

Placebo

The control will be a placebo capsule containing 336 mg of cellulose microcrystalline, matching the investigational product appearance.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Male
2. 50 to 70 years old
3. BMI 18.5-29.9 kg/m2
4. Healthy as per medical history and investigator's/ physician's judgement
5. Having given informed consent

Exclusion Criteria

1. Allergy/intolerance to the study product
2. \>5% body mass change in the previous 3 months
3. HbA1c ≥ 6.5%
4. Blood pressure \>140/90 mmHg
5. Participating in a structured (progressive) exercise program
6. Smoking
7. Diagnosed acute or chronic medical conditions that, in the opinion of the investigator, could impact study outcomes
8. Diagnosed musculoskeletal disorders
9. Chronic use of gastric acid suppressing medication
10. Unauthorized concomitant medications such as calcium antagonists (e.g. valproate), oral corticosteroids, anything that will prevent subjects from safely completing the study according to the investigator or medications / drugs known interfering with the expected mechanism of action of IP or to affect the outcome parameters
11. Alcohol (intake higher than 3 servings per day. One serving is 0.4 dl of alcohol, 1 dl of wine, or 3 dl of beer) or drug abuse
12. Overly imbalanced or restrictive diet (e.g. hyperproteic, vegan, ketogenic, etc.)
13. Subjects not willing and/or not able to comply with scheduled visits and the requirements of the study protocol
14. Any implants that would be a contra-indication for performing an MRI scan.
15. Participation in another study at the same time
16. Blood donation in the past 2 months

Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes