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A Randomized, Double-blind, Placebo-controlled study to investigate the efficacy of oleuropein on skeletal muscle energy metabolism and fatigue in humans

A Randomized, Double-blind, Placebo-controlled study to investigate the efficacy of oleuropein on skeletal muscle energy metabolism and fatigue in humans - Oleuropein and muscle energy metabolism

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50903
Enrollment
60
Registered
2021-10-15
Start date
2021-12-14
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

This study will evaluate the effects of oleuropein supplementation on muscle energy metabolism and fatigue Muscle energy metabolism Muscle energy utilization

Interventions

Participants will undergo a screening session, baseline measurement, and 4 test days. The first 2 test days will be performed at the beginning of the study in order to evaluate the acute effects of

Sponsors

Société des Produits Nestlé SA
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Male 2. 50 to 70 years old 3. BMI 18.5-29.9 kg/m2 4. Healthy 5. Having given informed consent

Exclusion criteria

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: systolic/diastolic >140/ and >90 mmHg (when both conditions are met) 5. Participating in a structured (progressive) exercise program 6. Smoking 7. Diagnosed acute or chronic medical conditions that, 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 donnation in the previous 2 months 17. Non-Dutch speaking

Design outcomes

Primary

MeasureTime frame
This is an exploratory trial with no formal primary or secondary outcomes

Secondary

MeasureTime frame
This is an exploratory trial with no formal primary or secondary outcomes

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)