Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 4:01 AM
Study NCT ID:
NCT07450066
Status:
COMPLETED
Last Update Posted:
2026-03-04
First Post:
2026-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Precision Lifestyle Intervention and Anthropometric, Nutritional, and Metabolic Health Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004032', 'term': 'Diet'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-26', 'studyFirstSubmitDate': '2026-02-26', 'studyFirstSubmitQcDate': '2026-02-26', 'lastUpdatePostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body Mass Index', 'timeFrame': 'Baseline, Month 3 of intervention, Month 6 (end) of intervention', 'description': 'BMI will be calculated from body weight and height using the formula: BMI = weight (kg) / height (m)²'}, {'measure': 'Body Fat Percentage', 'timeFrame': 'Baseline, Month 3 of intervention, Month 6 (end) of intervention', 'description': 'Body fat (%) will be assessed by bioelectrical impedance analysis (BIA)'}], 'secondaryOutcomes': [{'measure': 'Body Weight', 'timeFrame': 'Baseline, Month 3 of intervention, Month 6 (end) of intervention', 'description': 'Body weight will be measured in kilograms (kg) using a calibrated scale'}, {'measure': 'Waist Circumference', 'timeFrame': 'Baseline, Month 3 of intervention, Month 6 (end) of intervention', 'description': 'Waist Circumference will be measured in centimeters (cm) using a non-elastic tape measure'}, {'measure': 'Hip Circumferenc', 'timeFrame': 'Baseline, Month 3 of intervention, Month 6 (end) of intervention', 'description': 'Hip Circumference will be measured in centimeters (cm) using a non-elastic tape measure'}, {'measure': 'CUN-BAE', 'timeFrame': 'Baseline, Month 3 of intervention, Month 6 (end) of intervention', 'description': 'Body fat percentage will be estimated using the Clínica Universidad de Navarra - Body Adiposity Estimator (CUN-BAE) formula:\n\n%BF = -44.988 + (0.503 × age) + (10.689 × sex) + (3.172 × BMI) - (0.026 × BMI²) + (0.181 × BMI × sex) - (0.02 × BMI × age) - (0.005 × BMI² × sex) + (0.00021 × BMI² × age)\n\n(sex: 0 = male, 1 = female)'}, {'measure': 'Waist-to-hip ratio', 'timeFrame': 'Baseline, Month 3 of intervention, Month 6 (end) of intervention', 'description': 'Waist-to-hip ratio will be calculated as: waist circumference (cm) / hip circumference (cm).'}, {'measure': 'Waist-to-height ratio', 'timeFrame': 'Baseline, Month 3 of intervention, Month 6 (end) of intervention', 'description': 'Waist-to-height ratio will be calculated as: waist circumference (cm) / height (cm).'}, {'measure': 'Plasma Leptin', 'timeFrame': 'Baseline, Month 6 (end) of intervention', 'description': 'Plasma leptin levels will be measured in ng/mL using enzyme-linked immunosorbent assay (ELISA).'}, {'measure': 'Plasma Adiponectin', 'timeFrame': 'Baseline, Month 6 (end) of intervention', 'description': 'Plasma Adiponectin levels will be measured in µg/mL using ELISA.'}, {'measure': 'Adiponectin-Leptin Ratio', 'timeFrame': 'Baseline, Month 6 (end) of intervention', 'description': 'The adiponectin/leptin ratio will be calculated as: adiponectin (µg/mL) / leptin (ng/mL).'}, {'measure': 'Plasma Tumor necrosis factor alpha (TNF-α)', 'timeFrame': 'Baseline, Month 6 (end) of intervention', 'description': 'Plasma TNF-α will be measured in pg/mL using ELISA.'}, {'measure': 'Plasma Interleukin-6 (IL-6)', 'timeFrame': 'Baseline, Month 6 (end) of intervention', 'description': 'Plasma IL-6 measured in pg/mL using ELISA.'}, {'measure': 'Plasma Triglycerides', 'timeFrame': 'Baseline, Month 6 (end) of intervention', 'description': 'Plasma Triglycerides measured in mg/dL using enzymatic colorimetric commercial kit.'}, {'measure': 'Plasma Total Cholesterol', 'timeFrame': 'Baseline, Month 6 (end) of intervention', 'description': 'Plasma Total Cholesterol measured in mg/dL using enzymatic colorimetric commercial kit.'}, {'measure': 'Plasma High-Density Lipoprotein (HDL) cholesterol', 'timeFrame': 'Baseline, Month 6 (end) of intervention', 'description': 'Plasma HDL cholesterol measured in mg/dL using enzymatic colorimetric commercial kit after dextran precipitation.'}, {'measure': 'Plasma Low-Density Lipoprotein (LDL) cholesterol', 'timeFrame': 'Baseline, Month 6 (end) of intervention', 'description': 'Plasma LDL cholesterol levels (mg/dL) will be calculated using the Friedewald formula: LDL-C = Total Cholesterol - \\[HDL Cholesterol + (Triglycerides / 5)\\].'}, {'measure': 'Non-HDL Cholesterol', 'timeFrame': 'Baseline, Month 6 (end) of intervention', 'description': 'Non-HDL cholesterol will be calculated as: Total Cholesterol (mg/dL) - HDL cholesterol (mg/dL).'}, {'measure': 'Fasting glucose', 'timeFrame': 'Baseline, Month 6 (end) of intervention', 'description': 'Fasting glucose will be measured in mg/dL using a glucometer'}, {'measure': 'Fasting insulin', 'timeFrame': 'Baseline, Month 6 (end) of intervention', 'description': 'Fasting insulin will be measured in mU/L using ELISA.'}, {'measure': 'Insulin resistance will be estimated using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)', 'timeFrame': 'Baseline, Month 6 (end) of intervention', 'description': 'HOMA-IR = \\[fasting insulin (mU/L) × fasting glucose (mg/dL)\\] / 405'}, {'measure': 'Insulin sensitivity will be estimated using the Quantitative Insulin Sensitivity Check Index (QUICKI)', 'timeFrame': 'Baseline, Month 6 (end) of intervention', 'description': 'QUICKI = 1 / \\[log(fasting insulin µU/mL) + log(fasting glucose mg/dL)\\]'}, {'measure': 'Plasma Irisin', 'timeFrame': 'Baseline, Month 6 (end) of intervention', 'description': 'Plasma Irisin measured using ELISA.'}, {'measure': 'Plasma Fibroblast growth factor 21 (FGF-21)', 'timeFrame': 'Baseline, Month 6 (end) of intervention', 'description': 'Plasma FGF-21 measured using ELISA.'}, {'measure': 'Plasma Uric Acid', 'timeFrame': 'Baseline, Month 6 (end) of intervention', 'description': 'Plasma Uric Acid measured in mg/dL using enzymatic colorimetric commercial kit.'}, {'measure': 'Dietary intake assessment', 'timeFrame': 'Baseline, Month 3 of intervention, Month 6 (end) of intervention', 'description': 'Dietary intake will be evaluated using a 65-item Food Frequency Questionnaire (FFQ) for dietary pattern analysis.'}, {'measure': 'Physical Activity Level', 'timeFrame': 'Baseline, Month 3 of intervention, Month 6 (end) of intervention', 'description': 'Physical activity will be estimated using the International Physical Activity Questionnaire (IPAQ).'}, {'measure': 'Adherence to the Mediterranean diet', 'timeFrame': 'Baseline, Month 3 of intervention, Month 6 (end) of intervention', 'description': 'Adherence to the Mediterranean diet will be evaluated using the MEDAS questionnaire.'}, {'measure': 'Plasma Gamma-glutamyltransferase (γ-glutamyltransferase, GGT)', 'timeFrame': 'Baseline, Month 6 (end) of intervention', 'description': 'GGT activity determined in plasma using a commercial enzymatic assay kit for the quantitative measurement of γ-glutamyl transferase.'}, {'measure': 'Plasma alanine transaminase (ALT)', 'timeFrame': 'Baseline, Month 6 (end) of intervention', 'description': 'ALT activity determined in plasma using a commercial enzymatic assay kit for the quantitative measurement of alanine aminotransferase.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['personalized nutrition', 'nutrigenetics', 'biomarkers', 'obesity', 'overweight'], 'conditions': ['Obesity & Overweight']}, 'descriptionModule': {'briefSummary': 'This clinical trial aims to recruit a core cohort of adults with normal weight, overweight, and obesity, but without other metabolic alterations, to undergo a six-month nutritional intervention. The main objective is to compare a genotype- and phenotype-based nutrition approach with a traditional nutrition plan adjusted only to phenotype. To evaluate the effectiveness of each type of intervention, anthropometric measurements and nutritional assessments will be collected at baseline, three months, and six months. In addition, plasma samples will be obtained to analyze clinical and non-clinical biomarkers, providing a more comprehensive evaluation of health status at baseline and after six months of intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria: Men and women aged between 25 and 55 years; volunteers who sign the informed consent forms for sample collection and for participation in the study, after having read the information sheet of the research project; absence of known disease.\n\nExclusion criteria: participants younger than 25 years and older than 55 years; physically or legally incapacitated persons; pregnant or breastfeeding women; presence of blood-borne infectious diseases (HIV/AIDS, hepatitis, etc.); presence of diseases associated with a risk of complications during blood extraction (coagulation disorders, heart failure, etc.); individuals with diabetes, hypertension, grade II or higher obesity (BMI ≥35), or those receiving chronic medication (excluding contraceptives).'}, 'identificationModule': {'nctId': 'NCT07450066', 'acronym': 'MAR-GEN', 'briefTitle': 'Precision Lifestyle Intervention and Anthropometric, Nutritional, and Metabolic Health Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'University of the Balearic Islands'}, 'officialTitle': 'Estudio en Humanos Para la identificación de Biomarcadores de Actividad física Moderada y Sedentarismo y su Posible relación Con Determinantes genéticos e Indicadores Del Estado de Salud metabólica', 'orgStudyIdInfo': {'id': '3736/18mPI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Participants assigned to this arm (initially comprising 50 individuals) received nutritional counseling to promote adherence to a standard Mediterranean diet, based on general healthy eating guidelines for the Spanish adult population, along with phenotype-tailored recommendations for physical activity.', 'interventionNames': ['Other: Diet']}, {'type': 'EXPERIMENTAL', 'label': 'Personalized Nutrition', 'description': 'Participants in this arm were advised to follow a Mediterranean diet adapted through nutritional and physical activity recommendations tailored to their genetic profile, developed on the basis of a commercial nutrigenetic report.', 'interventionNames': ['Other: Diet']}], 'interventions': [{'name': 'Diet', 'type': 'OTHER', 'description': 'A six-month intervention consisting of lifestyle counseling aimed at promoting adherence to a standard Mediterranean diet and providing phenotype-tailored physical activity recommendations.', 'armGroupLabels': ['Control']}, {'name': 'Diet', 'type': 'OTHER', 'description': 'A 6-month intervention based on the Mediterranean diet with adaptations in nutritional and physical activity guidelines tailored to their genetic profile, according to the report of a commercial nutrigenetic test.', 'armGroupLabels': ['Personalized Nutrition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07122', 'city': 'Palma de Mallorca', 'state': 'Balearic Islands', 'country': 'Spain', 'facility': 'University of the Balearic Islands', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of the Balearic Islands', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}