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

Completed

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

• Registration Number: NL-OMON50903
• Lead Sponsor: Société des Produits Nestlé SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>This is an exploratory trial with no formal primary or secondary outcomes</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>This is an exploratory trial with no formal primary or secondary outcomes</p><br>