Healthy VolunteersNUTSPORTNCT05350566
Combined Effect of Exercise Intensity With Nutritional Supplementation on Skeletal Muscle Function
A study testing Olive leaf extract in people with Healthy Volunteers and Exercise Intensity, run by University of Lausanne at 1 site in Switzerland.
Trial summary
The main objective of this study is to determine the effectiveness of a nutritional intervention (olive leaf extract) combined with a specific training session (MICT or SIT) on PDH activation (as well as other protein expressions) and exercise-induced muscle fatigue. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Exercise Intensity, Neuromuscular Fatigue
- What is being tested?
- Olive leaf extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteSwitzerland
- Study dates
- 7 Jun 2022to 7 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being male (including females would necessitate increasing the number of included participants to consider sex as a variable which would burden the project too much).
- Being aged between 18 and 40 years
- Being healthy (The assessment will be done through a questionnaire and an interview/examination by a medical doctor if there is any doubts)
- Being physically active, but not involved in any structured training program
- Having stable dietary habits
Who cannot join
- Having previous medical events that would put the participant at risk during the study
- Ingesting caffeine on the experimental days
- Not being currently treated for blood clotting problems
- Taking aspirin or anti-coagulant drugs in the 48 hours preceding the experimental days in which muscle samples will be collected
- Having allergy to xylocaine
- Having food allergy
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of this study is to determine the effectiveness of a nutritional intervention (olive leaf extract) combined with a specific training session (MICT or SIT) on PDH activation (as well as other protein expressions) and exercise-induced muscle fatigue.
Read the detailed description
Sprint interval training (SIT) is a form of interval training characterised by short bursts of intense exercise interspersed with rest periods. SIT is as, or more, effective than moderate intensity continuous training (MICT) for systemic and metabolic adaptations of muscles, despite a lower workload and shorter duration. However, the mechanisms underlying the metabolic response to SIT versus MICT are poorly understood. Our recent work (Zanou et al. 2021) suggests that increased pyruvate dehydrogenase (PDH) activity may explain why a SIT session led to greater changes in proteins involved in mitochondrial respiration compared to a MICT session.
Recently, it was found that a natural and commercially available compound based on olive leaf extract could stimulate resting mitochondrial bioenergetics by activating the mitochondrial calcium uniporter (MCU), which is involved in calcium transport across the mitochondrial membrane, directly controlling PDH activity. The main objective of this study is to determine the effectiveness of an acute nutritional intervention (olive leaf extract) combined with a specific training session (MICT or SIT) on PDH activation (as well as other protein expressions) and exercise-induced muscle fatigue.
Participants will be allocated to either a SIT (6 x 30 s all out sprints) or a MICT (1h at 50% maximal aerobic power) group and asked to come to the laboratory for five visits including one familiarization session with a triangular test for maximal aerobic power determination, the first experimental session during which they will realize the exercise with the product or a placebo and a session 24h after to assess skeletal muscle adaptations. Then after a 3 week wash-out period, they report to the laboratory for the fourth and fifth session, identical to the second and third sessions but with the other intervention (product or placebo). Muscle microbiopsies will be collected from the vastus lateralis muscle before, immediately after and 24 hours after exercise (MICT or SIT), while knee extensor neuromuscular function will be assessed at the same time points using voluntary and electrically-evoked contractions.
- Conditions
- Healthy Volunteers, Exercise Intensity, Neuromuscular Fatigue, Skeletal Muscle Adaptations
- Being tested
- Olive leaf extract, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olive leaf extractDietary supplement
A capsule containing 250 mg of an olive leaf extract preparation will be swallowed with a glass of water before exercise.
PlaceboDietary supplement
A capsule containing 336 mg of cellulose microcrystalline will be swallowed with a glass of water before exercise.
| Study group | Role | What they receive |
|---|---|---|
| Sprint interval training group (SIT group) | Experimental | The model of sprint interval training (SIT) consists of six 30 s all-out cycling bouts on a cycle ergometer, with 4 min rests between tests. Receives: Dietary Supplement: Olive leaf extract; Dietary Supplement: Placebo |
| Moderate intensity continuous training (MICT group) | Experimental | The moderate intensity continuous training (MICT) consists of 1h cycling on a cycle ergometer at 50% of the maximal aerobic power output Receives: Dietary Supplement: Olive leaf extract; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PDH dephosphorylation
protein involved in skeletal muscle metabolism
Measured: before, immediately after and 24 hours after exercise completion
expression of OXPHOS proteins
proteins used as markers of oxidative phosphorylation complexes
Measured: before, immediately after and 24 hours after exercise completion
expression of MCU protein
protein involved in the transport of Ca2+ in the mitochondria
Measured: before, immediately after and 24 hours after exercise completion
Secondary outcomes (4)
Maximal voluntary contraction force
Maximal force of the knee extensor muscles
Measured: before, immediately after and 24 hours after exercise completion
Voluntary activation level
overall index of central fatigue induced by exercise
Measured: before, immediately after and 24 hours after exercise completion
Peak doublet evoked at 100 Hz
overall index of peripheral fatigue induced by exercise
Measured: before, immediately after and 24 hours after exercise completion
M-wave amplitude
index of neuromuscular excitability
Measured: before, immediately after and 24 hours after exercise completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start7 Jun 2022
- Primary completion7 Dec 2022
- Study completion7 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The design is a placebo-controlled, double blind, cross-over two-arm study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne
- Sponsor type
- University, hospital or other
- Collaborators
- Société des Produits Nestlé (SPN)
- Responsible party
- Principal investigator, Nicolas Place, University of Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05350566
- Sponsor's protocol ID
- 2021-00373
- Acronym
- NUTSPORT
- Status last verified
- May 2023
- First submitted
- 14 Apr 2022
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Place N, Ivarsson N, Venckunas T, Neyroud D, Brazaitis M, Cheng AJ, Ochala J, Kamandulis S, Girard S, Volungevicius G, Pauzas H, Mekideche A, Kayser B, Martinez-Redondo V, Ruas JL, Bruton J, Truffert A, Lanner JT, Skurvydas A, Westerblad H. Ryanodine receptor fragmentation and sarcoplasmic reticulum Ca2+ leak after one session of high-intensity interval exercise. Proc Natl Acad Sci U S A. 2015 Dec 15;112(50):15492-7. doi: 10.1073/pnas.1507176112. Epub 2015 Nov 2.
PubMed 26575622Zanou N, Dridi H, Reiken S, Imamura de Lima T, Donnelly C, De Marchi U, Ferrini M, Vidal J, Sittenfeld L, Feige JN, Garcia-Roves PM, Lopez-Mejia IC, Marks AR, Auwerx J, Kayser B, Place N. Acute RyR1 Ca2+ leak enhances NADH-linked mitochondrial respiratory capacity. Nat Commun. 2021 Dec 10;12(1):7219. doi: 10.1038/s41467-021-27422-1.
PubMed 34893614
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effect of Exercise Intensity With Nutritional Supplementation on Skeletal Muscle Function
- ClinicalTrials.gov ID
- NCT05350566
- Acronym / sponsor ID
- NUTSPORT / 2021-00373
- Conditions
- Healthy Volunteers, Exercise Intensity, Neuromuscular Fatigue, Skeletal Muscle Adaptations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of LausanneUniversity, hospital or other
- Collaborators
- Société des Produits Nestlé (SPN)
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- 7 Dec 2022 (actual)
- Study completion
- 7 Dec 2022 (actual)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to determine the effectiveness of a nutritional intervention (olive leaf extract) combined with a specific training session (MICT or SIT) on PDH activation (as well as other protein expressions) and exercise-induced muscle fatigue.
Detailed description
Sprint interval training (SIT) is a form of interval training characterised by short bursts of intense exercise interspersed with rest periods. SIT is as, or more, effective than moderate intensity continuous training (MICT) for systemic and metabolic adaptations of muscles, despite a lower workload and shorter duration. However, the mechanisms underlying the metabolic response to SIT versus MICT are poorly understood. Our recent work (Zanou et al. 2021) suggests that increased pyruvate dehydrogenase (PDH) activity may explain why a SIT session led to greater changes in proteins involved in mitochondrial respiration compared to a MICT session.
Recently, it was found that a natural and commercially available compound based on olive leaf extract could stimulate resting mitochondrial bioenergetics by activating the mitochondrial calcium uniporter (MCU), which is involved in calcium transport across the mitochondrial membrane, directly controlling PDH activity. The main objective of this study is to determine the effectiveness of an acute nutritional intervention (olive leaf extract) combined with a specific training session (MICT or SIT) on PDH activation (as well as other protein expressions) and exercise-induced muscle fatigue.
Participants will be allocated to either a SIT (6 x 30 s all out sprints) or a MICT (1h at 50% maximal aerobic power) group and asked to come to the laboratory for five visits including one familiarization session with a triangular test for maximal aerobic power determination, the first experimental session during which they will realize the exercise with the product or a placebo and a session 24h after to assess skeletal muscle adaptations. Then after a 3 week wash-out period, they report to the laboratory for the fourth and fifth session, identical to the second and third sessions but with the other intervention (product or placebo). Muscle microbiopsies will be collected from the vastus lateralis muscle before, immediately after and 24 hours after exercise (MICT or SIT), while knee extensor neuromuscular function will be assessed at the same time points using voluntary and electrically-evoked contractions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The design is a placebo-controlled, double blind, cross-over two-arm study
| Arm | Type | Receives |
|---|---|---|
| Sprint interval training group (SIT group) | Experimental | Dietary Supplement: Olive leaf extract, Dietary Supplement: PlaceboThe model of sprint interval training (SIT) consists of six 30 s all-out cycling bouts on a cycle ergometer, with 4 min rests between tests. |
| Moderate intensity continuous training (MICT group) | Experimental | Dietary Supplement: Olive leaf extract, Dietary Supplement: PlaceboThe moderate intensity continuous training (MICT) consists of 1h cycling on a cycle ergometer at 50% of the maximal aerobic power output |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Being male (including females would necessitate increasing the number of included participants to consider sex as a variable which would burden the project too much).
- Being aged between 18 and 40 years
- Being healthy (The assessment will be done through a questionnaire and an interview/examination by a medical doctor if there is any doubts)
- Being physically active, but not involved in any structured training program
- Having stable dietary habits
Key exclusion criteria (6 listed)
- Having previous medical events that would put the participant at risk during the study
- Ingesting caffeine on the experimental days
- Not being currently treated for blood clotting problems
- Taking aspirin or anti-coagulant drugs in the 48 hours preceding the experimental days in which muscle samples will be collected
- Having allergy to xylocaine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olive leaf extractA capsule containing 250 mg of an olive leaf extract preparation will be swallowed with a glass of water before exercise. | Dietary supplement | Moderate intensity continuous training (MICT group), Sprint interval training group (SIT group) |
| PlaceboA capsule containing 336 mg of cellulose microcrystalline will be swallowed with a glass of water before exercise. | Dietary supplement | Moderate intensity continuous training (MICT group), Sprint interval training group (SIT group) |
Primary outcome
PDH dephosphorylation
Time frame: before, immediately after and 24 hours after exercise completion
protein involved in skeletal muscle metabolism
expression of OXPHOS proteins
Time frame: before, immediately after and 24 hours after exercise completion
proteins used as markers of oxidative phosphorylation complexes
expression of MCU protein
Time frame: before, immediately after and 24 hours after exercise completion
protein involved in the transport of Ca2+ in the mitochondria
4 secondary outcomes
Maximal voluntary contraction force
Time frame: before, immediately after and 24 hours after exercise completion
Voluntary activation level
Time frame: before, immediately after and 24 hours after exercise completion
Peak doublet evoked at 100 Hz
Time frame: before, immediately after and 24 hours after exercise completion
M-wave amplitude
Time frame: before, immediately after and 24 hours after exercise completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Background: PubMed 26575622Place N, Ivarsson N, Venckunas T, Neyroud D, Brazaitis M, Cheng AJ, Ochala J, Kamandulis S, Girard S, Volungevicius G, Pauzas H, Mekideche A, Kayser B, Martinez-Redondo V, Ruas JL, Bruton J, Truffert A, Lanner JT, Skurvydas A, Westerblad H. Ryanodine receptor fragmentation and sarcoplasmic reticulum Ca2+ leak after one session of high-intensity interval exercise. Proc Natl Acad Sci U S A. 2015 Dec 15;112(50):15492-7. doi: 10.1073/pnas.1507176112. Epub 2015 Nov 2.
- Background: PubMed 34893614Zanou N, Dridi H, Reiken S, Imamura de Lima T, Donnelly C, De Marchi U, Ferrini M, Vidal J, Sittenfeld L, Feige JN, Garcia-Roves PM, Lopez-Mejia IC, Marks AR, Auwerx J, Kayser B, Place N. Acute RyR1 Ca2+ leak enhances NADH-linked mitochondrial respiratory capacity. Nat Commun. 2021 Dec 10;12(1):7219. doi: 10.1038/s41467-021-27422-1.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olive leaf extract in people with Healthy Volunteers and Exercise Intensity, run by University of Lausanne at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PDH dephosphorylation (time frame: before, immediately after and 24 hours after exercise completion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05350566, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023; AzTrials last refreshed its copy on 26 Oct 2026.