Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-04-04 @ 5:46 PM
Study NCT ID:
NCT07445503
Status:
RECRUITING
Last Update Posted:
2026-03-03
First Post:
2026-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Phenolic Olive Oil for Enhancing Metabolic Health: a Randomized-controlled Trial in Patients With cEntral Obesity (HOPE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'double-blind, parallel group, randomized-controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-26', 'studyFirstSubmitDate': '2026-02-20', 'studyFirstSubmitQcDate': '2026-02-26', 'lastUpdatePostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Statistically significant change of blood triglyceride levels between the two olive oil groups at the trial endpoint.', 'timeFrame': 'Trial endtpoint (8 weeks)'}], 'secondaryOutcomes': [{'measure': 'Statistically significant change of blood pressure between the two olive oil groups at the trial endpoint.', 'timeFrame': 'Trial endpoint (8 weeks)'}, {'measure': 'Statistically significant change of fasting glucose levels between the two olive oil groups at trial endpoint.', 'timeFrame': 'Trial endpoint (8 weeks)'}, {'measure': 'Statistically significant change of low-density lipoprotein (LDL) levels between the two olive oil groups at trial endpoint.', 'timeFrame': 'Trial endpoint (8 weeks)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['extra virgin, high-phenolic olive oil', 'overweight', 'obesity', 'metabolic disorders', 'metabolism', 'oxidative stress', 'inflammation'], 'conditions': ['Adults', 'Overweight , Obesity', 'Metabolic Abnormalities', 'Consented to Participate in the Trial and Signed an ICF']}, 'descriptionModule': {'briefSummary': 'Olive oil is a fundamental component of the Mediterranean diet and a major source of monounsaturated fatty acids with well-established cardioprotective properties. When rich in phenolic compounds-such as hydroxytyrosol, tyrosol, oleuropein, oleocanthal, oleacein, and ligstroside aglycone-it is considered a functional food with antioxidant, anti-inflammatory, cardioprotective, chemoprotective, and neuroprotective effects. According to EU Regulation 432/2012, daily consumption of 20 g of extra virgin olive oil containing at least 5 mg of hydroxytyrosol and tyrosol derivatives (250 mg/kg) contributes to the protection of blood lipids from oxidative stress and qualifies for a health claim.\n\nOverweight/obesity, characterized by excessive fat accumulation, is strongly associated with non-communicable diseases, including cardiovascular disease, type 2 diabetes, hypertension, certain cancers, and neurodegenerative disorders. Chronic low-grade inflammation and oxidative stress are key mechanisms underlying obesity-related metabolic disorders. Although dietary energy restriction remains the primary approach for weight management, growing research interest focuses on natural products rich in phenolic compounds as potential modulators of molecular pathways involved in central obesity.\n\nHowever, robust clinical evidence in humans with central obesity and metabolic abnormalities remains limited. Therefore, this double-blind, randomized, controlled trial aims to investigate the effects of extra virgin, high-phenolic olive oil (HPOO) compared with low-phenolic olive oil (LPOO) in adults with overweight/obesity with metabolic abnormalities. Participants will consume the assigned olive oil type (HPOO or LPOO) for eight weeks.\n\nAt baseline and trial endpoint (8 weeks), data collection will include anthropometric measurements, dietary intake, biochemical indices, inflammatory and oxidative stress markers in blood samples, hormones, bioavailability of phenolic compounds, as well as lifestyle parameters i.e., health-related quality of life, physical activity levels, sleep quality. Ethical approval, informed consent, and data protection procedures will be strictly followed. Statistical analyses will be conducted using SPSS software (SPSS Inc, ΙΒΜ, Chicago, IL, USA).\n\nThe study is anticipated to explore whether consumption of high-phenolic olive oil favorably modulates markers related to obesity and metabolic abnormalities, while also improving nutritional status and quality-of-life parameters.', 'detailedDescription': 'Materials and methods The present study is designed as a double-blind, randomized, controlled clinical trial. A total of 70-80 adult men and women (\\>18 years old) with overweight or obesity (BMI \\>25 kg/m² and waist circumference \\>94 cm for men and \\>80 cm for women) and at least one metabolic abnormality (dyslipidemia, arterial hypertension, insulin resistance, or type 2 diabetes mellitus) will be recruited.\n\nIndividuals will be excluded if they are currently taking dietary supplements (e.g., multivitamin preparations), suffer from acute or chronic diseases (e.g., cancer, autoimmune disorders, insulin-treated diabetes), follow a strict vegetarian/vegan diet, abuse alcohol and/or illicit substances, or decline to provide written informed consent.\n\nParticipants will be instructed to consume daily, for a total duration of eight weeks either high phenolic olive oil (HPOO), containing \\>1000 mg/kg total polyphenols, or low phenolic olive oil (LPOO), containing ≤100 mg/kg total polyphenols. The quantity of olive oil administered will be determined based on individual fat energy requirements, aiming to promote mild weight loss.\n\nParticipants will be allocated to one of the two intervention groups using simple randomization (1:1), conducted by an independent researcher. Both groups will receive standardized dietary guidance for mild weight loss according to the National Dietary Guidelines to ensure homogeneity of the intervention.\n\nMeasurements and data collection will be conducted at baseline and at the end of the intervention (week 0 and week 8), during morning visits following an overnight fast, at the University facilities:\n\n* Socio-demographic characteristics and detailed medical history.\n* Measurement of arterial blood pressure and heart rate.\n* Measurement of resting metabolic rate (RMR) and respiratory quotient (RQ) (Cosmed Quark RMR, Rome, Italy).\n* Blood sampling; a total of 20 mL of venous blood will be collected for serum and plasma isolation. Samples will be stored at -80°C until further analysis.\n* Blood sample analysis; hormones, inflammatory- and oxidative stress markers assessed via enzyme-linked immunosorbent assay (ELISA) and spectrophotometric techniques, bioavailability of phenolic compounds analyzed with chromatography instrumentation available at the University of Peloponnese.\n* Anthropometric measurements; height and body weight, body composition with bioelectrical impedance (TANITA Corporation, Tokyo, Japan), waist and hip circumferences, handgrip strength (Takei A5401 Hand Dynamometer, Takei Scientific Instruments Co., Ltd., Niigata, Japan).\n* Questionnaires: Validated and standardized questionnaires for the Greek population will be administered, namely Food Frequency Questionnaire (FFQ), MedDiet Score, 24-hour dietary recall, 36-Item Short Form Health Survey (SF-36), Athens Insomnia Scale (AIS), Rosenberg Self-Esteem Scale (RSES), Depression Anxiety Stress Scale-21 (DASS-21), Profile of Mood States (POMS-short), Athens Physical Activity Questionnaire (APAQ).\n\nOlive oil products (HPOO or LPOO) will be provided to participants every two weeks in identical, airtight containers suitable for olive oil storage, following microbiological quality control by the distribution company. Prior to each distribution, total phenolic content will be quantified using the Folin-Ciocalteu method.\n\nThe study follows a double-blind design: neither participants nor investigators will be aware of group allocation (HPOO or LPOO). The allocation code will be accessible only to the Principal Investigator.\n\nEvery two weeks during the intervention, telephone follow-up will be conducted to assess dietary habits, including compliance with olive oil consumption, using 24-hour dietary recall methodology. Any reported adverse effects related to olive oil intake will also be recorded.\n\nThe study will be conducted in accordance with the Code of Ethics and Research Ethics Committee of the University of the Peloponnese (4213/21-02-2025), as well as with the Declaration of Helsinki (1964) and its later amendmends. Furthermore, all applicable national and international regulations regarding the protection of personal data in research will be strictly observed. Prior to the initiation of the intervention, all participants will be thoroughly informed by the Principal Investigator about the study protocol, its potential benefits, and any possible risks. Individuals who wish to participate will be required to provide written informed consent before enrollment. All data will be stored and managed under the responsibility of the Principal Investigator. Any questions related to the study procedures or to the outcomes of the intervention will be fully addressed. Participation is strictly voluntary, and participants have the right to withdraw from the study at any time without any consequences. They may also decline to answer any questions or to undergo any measurement or blood sampling procedure without penalty.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult men and women 18-80 years of age,\n* Overweight/obesity (body mass index \\> 25 or waist circumference \\>94 cm for males and \\>80 cm for females), and\n* The presence of at least one of the following metabolic abnormality: (1) triglyceride level ≥150 mg/dL or HDL cholesterol ≤40 mg/dL in men and ≤50 mg/dL in women; (2) increased blood pressure ≥ 130/85 mm Hg; (3) elevated fasting blood sugar ≥100 mg/dL; (4) standardized drug treatment regimen, and\n* Provided signed informed consent for participation.\n\nExclusion Criteria:\n\n* Concomitant acute or chronic disease (e.g., infection, cancer, chronic heart failure, kidney disease, autoimmune diseases like rheumatoid arthritis, inflammatory bowel diseases, Hashimoto),\n* Untreated diabetes,\n* Women at pregnancy or lactation,\n* Individuals with psychiatric or mental disorder,\n* Any use of antioxidant-phytochemical rich supplement, anti-, pre- or probiotics pre-intervention,\n* Drug and/or alcohol abuse,\n* Those who did not consent or were unable to provide consent.'}, 'identificationModule': {'nctId': 'NCT07445503', 'acronym': 'HOPE', 'briefTitle': 'High Phenolic Olive Oil for Enhancing Metabolic Health: a Randomized-controlled Trial in Patients With cEntral Obesity (HOPE)', 'organization': {'class': 'OTHER', 'fullName': 'University of Peloponnese'}, 'officialTitle': 'High Phenolic Olive Oil for Enhancing Metabolic Health: a Randomized-controlled Trial in Patients With Central Obesity', 'orgStudyIdInfo': {'id': '4213/21-02-2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Control arm', 'description': 'Participants assigned to the control arm receive olive oil with a low content in phenolic compounts.', 'interventionNames': ['Other: Low phenolic olive oil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention arm', 'description': 'Participants assigned to the intervention arm receive extra virgin olive oil rich in phenolic compounds.', 'interventionNames': ['Other: High phenolic olive oil']}], 'interventions': [{'name': 'Low phenolic olive oil', 'type': 'OTHER', 'description': 'Olive oil with low content of phenolic compounds.', 'armGroupLabels': ['Control arm']}, {'name': 'High phenolic olive oil', 'type': 'OTHER', 'description': 'Extra virgin olive oil rich in phenolic compounds.', 'armGroupLabels': ['Intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24100', 'city': 'Kalamata', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Aristea Gioxari', 'role': 'CONTACT', 'email': 'a.gioxari@uop.gr', 'phone': '2721045326'}], 'facility': 'Antikalamos Facilities of University of Peloponnese', 'geoPoint': {'lat': 37.03913, 'lon': 22.11265}}], 'centralContacts': [{'name': 'Aristea Gioxari, Assistant Professor', 'role': 'CONTACT', 'email': 'a.gioxari@go.uop.gr', 'phone': '+302721045326'}, {'name': 'Alexandra Foscolou, PhD', 'role': 'CONTACT', 'email': 'alexandra.foscolou@go.uop.gr', 'phone': '+306932621082'}], 'overallOfficials': [{'name': 'Aristea Gioxari', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Nutritional Science and Dietetics, School of Health Sciences, University of Peloponnese'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Ethical and privacy restrictions'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Peloponnese', 'class': 'OTHER'}, 'collaborators': [{'name': 'Harokopio University', 'class': 'OTHER'}, {'name': 'University of the Aegean', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor in "Clinical Nutrition and Macronutrient Metabolism"', 'investigatorFullName': 'Aristea Gioxari', 'investigatorAffiliation': 'University of Peloponnese'}}}}