Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2026-01-09 @ 9:37 AM
Study NCT ID:
NCT05217433
Status:
COMPLETED
Last Update Posted:
2023-03-17
First Post:
2021-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oleuropein and Muscle Energy Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000716987', 'term': 'olive leaf extract'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'This is a single-centre, double-blind, placebo controlled, randomised 2-arms parallel group study.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a single-centre, double-blind, placebo controlled, randomised 2-arms parallel group study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-16', 'studyFirstSubmitDate': '2021-11-25', 'studyFirstSubmitQcDate': '2022-01-19', 'lastUpdatePostDateStruct': {'date': '2023-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exploratory outcomes - Evaluate the changes in Pyruvate dehydrogenase activation between oleuropein and placebo groups following 1 single dose', 'timeFrame': 'Chronic effect after 36 days of intake', 'description': 'measured by western blotting'}, {'measure': 'Exploratory outcomes - Evaluate the changes in Pyruvate dehydrogenase activation between oleuropein and placebo groups following 1 single dose', 'timeFrame': 'Acute effect after first product intake + chronic effect after 36 days of intake', 'description': 'measured by biochemical assay analysis'}, {'measure': 'Exploratory outcomes - to evaluate the changes Mitocondrial respiration between oleuropein and placebo groups following 1 single dose', 'timeFrame': 'Acute effect after first product intake + chronic effect after 36 days of intake', 'description': 'measured the rates of oxygen consumption (respiration or JO2) using Oroboros Oxygraph 2K systems with physiological ADP concentrations using permeabilized muscle fibres.'}, {'measure': 'Exploratory outcomes- to evaluate the changes of fatigue between oleuropein and placebo groups following 1 single dose', 'timeFrame': 'After 4 weeks of supplementation', 'description': 'measured using Biodex dynamometer'}, {'measure': 'Exploratory outcomes - to evaluate the changes of fatigue between oleuropein and placebo groups', 'timeFrame': 'Chronic effect (after 29 days of supplementation)', 'description': 'measured using Biodex dynamometer'}, {'measure': 'Exploratory outcomes - to evaluate the changes of Pyruvate dehydrogenase activation between oleuropein and placebo groups', 'timeFrame': 'Chronic effect (after 36 days of supplementation)', 'description': 'measured by western blotting'}, {'measure': 'Exploratory outcomes - to evaluate the changes of Pyruvate dehydrogenase activation between oleuropein and placebo groups', 'timeFrame': 'Chronic effect (after 36 days of supplementation)', 'description': 'measured by biochemical assay analysis'}, {'measure': 'Exploratory outcomes - To evaluate the changes of Mitochondrial respiration between oleuropein and placebo groups', 'timeFrame': 'Chronic effect (after 36 days of supplementation)', 'description': 'measured the rates of oxygen consumption (respiration or JO2) using Oroboros Oxygraph 2K systems with physiological ADP concentrations using permeabilized muscle fibres.'}], 'secondaryOutcomes': [{'measure': 'Exploratory outcomes - to evaluate the changes of whole body respiratory exchange ratio (RER) between oleuropein and placebo groups following 1 single dose', 'timeFrame': 'Acute effect after first product intake+ chronic effect after 36 days of intake', 'description': 'measured the oxygen and carbon dioxide volume using indirect calorimetry with ventilated hood'}, {'measure': 'Exploratory outcomes - to evaluate the changes of oleuropein metabolites between oleuropein and placebo groups following 1 single dose', 'timeFrame': 'Acute effect after first product intake + chronic effect after 36 days of intake', 'description': 'measured by the analyze of oleuropein metabolites in blood'}, {'measure': 'Exploratory outcomes - to evaluate the changes of glucose concentration between oleuropein and placebo groups following 1 single dose', 'timeFrame': 'Acute effect after first product intake + chronic effect after 36 days of intake', 'description': 'measured by the analyze glucose in blood'}, {'measure': 'Exploratory outcomes - to evaluate the changes Blood glucose, insulin, free fatty acid concentrations -between oleuropein and placebo groups following 1 single dose', 'timeFrame': 'Acute effect after first product intake + chronic effect after 36 days of intake', 'description': 'measured by the analyze of Insulin in blood'}, {'measure': 'Exploratory outcomes - to evaluate the changes of free fatty acid concentration between oleuropein and placebo groups following 1 single dose', 'timeFrame': 'Acute effect after first product intake + chronic effect after 36 days of intake', 'description': 'measured by the analyze of free fatty acid concentration (FFA, TG) in blood'}, {'measure': 'Exploratory outcomes - to evaluate the changes of blood pressure between oleuropein and placebo groups following 1 single dose', 'timeFrame': 'Acute effect after first product intake + chronic effect after 36 days of intake', 'description': 'measured using automated inflatable cuff'}, {'measure': 'Exploratory outcomes - to evaluate the changes of anti-inflammatory markers between oleuropein and placebo groups', 'timeFrame': 'Chronic effect (after 29 days of supplementation)', 'description': 'measured by the analyze of anti-inflammatory markers in blood'}, {'measure': 'Exploratory outcomes - to evaluate the changes of Antioxidant markers between oleuropein and placebo groups', 'timeFrame': 'Chronic effect (after 29 days of supplementation)', 'description': 'measured by the analyze of antioxidant markers in blood'}, {'measure': 'Exploratory outcomes - to evaluate the changes in glucose concentration between oleuropein and placebo groups', 'timeFrame': 'Chronic effect (after 29 days of supplementation)', 'description': 'measured by the analyze glucose in blood'}, {'measure': 'Exploratory outcomes - to evaluate the changes of insulin concentration between oleuropein and placebo groups', 'timeFrame': 'Chronic effect (after 29 days of supplementation)', 'description': 'measured by the analyze of insulin in blood'}, {'measure': 'Exploratory outcomes - to evaluate the changes of free fatty acid concentration between oleuropein and placebo groups', 'timeFrame': 'Chronic effect (after 29 days of supplementation)', 'description': 'measured by the analyze of free fatty acid concentration (FFA, TG) in blood'}, {'measure': 'Exploratory outcomes - to evaluate the changes in Mood state and quality of life between oleuropein and placebo groups', 'timeFrame': 'Chronic effect (after 29 days of supplementation)', 'description': "measured with the World Health Organisation quality of life questionnaire (WHOQOL-BREF) (rating 0 for 'not at all' and 5 for 'an extreme amount')"}, {'measure': 'Exploratory outcomes - to evaluate the changes in Mood state and quality of life between oleuropein and placebo groups', 'timeFrame': 'Chronic effect (after 29 days of supplementation)', 'description': "measured with the Profile of Mood States - short-form (POMS-SF) - scale (rating 0 for 'not at all' and 4 for 'extremely')"}, {'measure': 'Exploratory outcomes - to evaluate the changes in Mood state and quality of life between oleuropein and placebo groups', 'timeFrame': 'Chronic effect (after 29 days of supplementation)', 'description': 'measured with the Quality of Life (QoL) questionnaires'}, {'measure': 'Exploratory outcomes - to evaluate the changes in the fatigue perception and mood state pre/post Biodex measurement between oleuropein and placebo groups', 'timeFrame': 'Chronic effect (after 29 days of supplementation)', 'description': "measured with the current mood questionnaire (rating 0 for 'not at all' - 4 for 'extremely')"}, {'measure': 'Exploratory outcomes - to evaluate the changes in the fatigue perception and mood state pre/post Biodex measurement between oleuropein and placebo groups', 'timeFrame': 'Chronic effect (after 29 days of supplementation)', 'description': "RPE visual analog scale Questionnaire - BORG scale (6 for 'no exertion - 20 for 'maximal exertion'"}, {'measure': 'Exploratory outcomes to evaluate the changes in body composition between oleuropein and placebo groups', 'timeFrame': 'Chronic effect (after 29 days of supplementation)', 'description': 'measure the whole body muscle and fat content using Magnetic resonance imaging (MRI)'}, {'measure': 'Exploratory outcomes - Whole body respiratory exchange ratio - To evaluate the changes of Whole body respiratory exchange ratio (RER) between oleuropein and placebo groups', 'timeFrame': 'Chronic effect (after 36 days of supplementation)', 'description': 'measure the oxygen and dioxygen volume using Indirect calorimetry with ventilation hood'}, {'measure': 'Exploratory outcomes - To evaluate the changes of oleuropein metabolites between oleuropein and placebo groups', 'timeFrame': 'Chronic effect (after 36 days of supplementation)', 'description': 'measure by analyzing Oleuropein metabolites in blood'}, {'measure': 'Exploratory outcomes - to evaluate the changes of molecular signalling, and protein and mRNA levels of regulators of muscle metabolism between oleuropein and placebo groups', 'timeFrame': 'Chronic effect (after 36 days of supplementation)', 'description': 'measured by analyzing RNAseq and MS-based proteomics'}, {'measure': 'Exploratory outcomes - to evaluate the changes of molecular signalling, and protein and mRNA levels of regulators oleuropein and placebo groups', 'timeFrame': 'Chronic effect (after 36 days of supplementation)', 'description': 'measured using Western Blot'}, {'measure': 'Exploratory outcomes - to evaluate the changes of molecular signalling, and protein and mRNA levels of regulators oleuropein and placebo groups', 'timeFrame': 'Chronic effect (after 36 days of supplementation)', 'description': 'measured by analyzing polymerase chain reaction'}, {'measure': 'Exploratory outcomes - to evaluate the changes in Strength between oleuropein and placebo groups', 'timeFrame': 'After 4 weeks of supplementation', 'description': 'measured using biodex dynanometer'}, {'measure': 'Exploratory outcomes to evaluate the changes of strenght between oleuropein', 'timeFrame': 'Chronic effect (after 29 days of supplementation)', 'description': 'measured using biodex dynanometer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Skeletal muscle energy and fatigue'], 'conditions': ['Muscular Fatigue']}, 'referencesModule': {'references': [{'pmid': '39993475', 'type': 'DERIVED', 'citation': 'Pinckaers PJ, Petrick HL, Horstman AM, Moreno-Asso A, De Marchi U, Hendriks FK, Kuin LM, Fuchs CJ, Grathwohl D, Verdijk LB, Zorenc AH, Senden JM, Migliavacca E, Metairon S, Poquet L, Morin-Rivron D, Karagounis LG, Holloway GP, Feige JN, van Loon LJ. Oleuropein Supplementation Increases Resting Skeletal Muscle Fractional Pyruvate Dehydrogenase Activity but Does Not Influence Whole-Body Metabolism: A Randomized, Double-Blind, and Placebo-Controlled Trial in Healthy, Older Males. J Nutr. 2025 May;155(5):1373-1386. doi: 10.1016/j.tjnut.2025.02.015. Epub 2025 Feb 22.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'genderBased': True, 'genderDescription': "1. Male\n2. 50 to 70 years old\n3. BMI 18.5-29.9 kg/m2\n4. Healthy as per medical history and investigator's/ physician's judgement\n5. Having given informed consent", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male\n2. 50 to 70 years old\n3. BMI 18.5-29.9 kg/m2\n4. Healthy as per medical history and investigator's/ physician's judgement\n5. Having given informed consent\n\nExclusion Criteria:\n\n1. Allergy/intolerance to the study product\n2. \\>5% body mass change in the previous 3 months\n3. HbA1c ≥ 6.5%\n4. Blood pressure \\>140/90 mmHg\n5. Participating in a structured (progressive) exercise program\n6. Smoking\n7. Diagnosed acute or chronic medical conditions that, in the opinion of the investigator, could impact study outcomes\n8. Diagnosed musculoskeletal disorders\n9. Chronic use of gastric acid suppressing medication\n10. 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\n11. 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\n12. Overly imbalanced or restrictive diet (e.g. hyperproteic, vegan, ketogenic, etc.)\n13. Subjects not willing and/or not able to comply with scheduled visits and the requirements of the study protocol\n14. Any implants that would be a contra-indication for performing an MRI scan.\n15. Participation in another study at the same time\n16. Blood donation in the past 2 months"}, 'identificationModule': {'nctId': 'NCT05217433', 'briefTitle': 'Oleuropein and Muscle Energy Metabolism', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'A Randomized, Double-blind, Placebo Controlled Study to Investigate the Efficacy of Oleuropein on Skeletal Muscle Energy Metabolism and Fatigue in Humans', 'orgStudyIdInfo': {'id': '20.22.NRC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Investigational product', 'description': '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).', 'interventionNames': ['Other: Olive leaf extract']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control arm', 'description': 'The control will be a placebo capsule containing 336 mg of cellulose microcrystalline, matching the investigational product appearance.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Olive leaf extract', 'type': 'OTHER', 'description': '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).', 'armGroupLabels': ['Investigational product']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'The control will be a placebo capsule containing 336 mg of cellulose microcrystalline, matching the investigational product appearance.', 'armGroupLabels': ['Control arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Maastricht University Medical Centre +', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Luc van Loon', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Maastricht University Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}