The objective of this exploratory trial is to explore the acute and chronic effects of daily olive leaf extract supplementation on muscle energy and fatigue in healthy male adults
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
This study will evaluate the effects of oleuropein supplementation on muscle energy metabolism and fatigue
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
This is an exploratory trial with no formal primary or secondary outcomes
Secondary outcome
This is an exploratory trial with no formal primary or secondary outcomes
Background summary
During aging, changes occur in our muscles. Among others, the muscles become
weaker and are more easily fatigued. These differences eventually could lead to
a decrease in functional capacity. Recently, an extract from olive leaves has
been discovered to improve muscle energy metabolism and thereby reducing muscle
fatigue in animal studies. However, whether this supplement would also be
effective in humans is not yet known.
Study objective
The objective of this exploratory trial is to explore the acute and chronic
effects of daily olive leaf extract supplementation on muscle energy and
fatigue in healthy male adults
Study design
Parallel design, randomized, dubble-blind
Intervention
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 the supplement. The last 2 test days
will be performed at the end of the research period, in order to evaluate the
prolonged effect of supplement ingestion.
Study burden and risks
The burden and risks involved in participating in this experiment are small.
Participants will visit the University on six occasions (screening + 1
familiarization + 4 Test Days). The first visit will involve a screening visit
(~2 h), during which the eligibility of the participant will be assessed.
During the screening visit, a medical questionnaire will be filled out, a
fasted blood sample will be obtained.
During the study, participants will perform a maximal strenght test and a
muscle fatigue test on a Biodex dynamometer on several occasions, which results
in acute muscle fatigue and may result in muscle soreness, comparable to
performing leg exercises at the gym. The subjects will undergo a full body MRI
scan. An MRI scan is non-invasive and safety is guaranteed by excluding
participants with MRI contra-indications. Blood samples will be taken
trhoughout the study with the only risk of a small local hematoma. Furthermore,
the respiratory exchange ratio (RER) will be assessed by a ventilated hood
(indirect calorimetry) which does not impose health risks. Muscle biopsies will
be obtained under local anaesthesia by an experienced physician that may cause
some minor discomfort. The discomfort is comparable to muscle soreness or the
pain one has after bumping into the corner of a table. The Olive leaf extract
supplement is cleared for human consumption and is commercially available. The
recommended daily allowance is not exceeded during this study. For each visit,
participants are required to come to the university in a fasted state, not
having consumed any food or beverages (except for water) from 22:00 the evening
before. There is no direct benefit of participation in this study for the
participants, other than their contribution to scientific knowledge.
Avenue Nestlé 55
Vevey 1800
CH
Avenue Nestlé 55
Vevey 1800
CH
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL77527.068.21 |
| Other | Protocol will be registered at ClinicalTrials.gov after approval by the METC |