Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-26 @ 1:26 AM
Study NCT ID:
NCT05382533
Status:
COMPLETED
Last Update Posted:
2023-02-06
First Post:
2022-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MoKaRi II Intervention Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008612', 'term': 'Menu Planning'}], 'ancestors': [{'id': 'D005522', 'term': 'Food Services'}, {'id': 'D019649', 'term': 'Food Industry'}, {'id': 'D007221', 'term': 'Industry'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D005521', 'term': 'Food Service, Hospital'}, {'id': 'D004045', 'term': 'Dietary Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'parallel design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-02', 'studyFirstSubmitDate': '2022-05-16', 'studyFirstSubmitQcDate': '2022-05-16', 'lastUpdatePostDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Creatinine (mmol/l)', 'timeFrame': 'Change from baseline after 10 weeks', 'description': 'Creatinine (24 h urine)'}, {'measure': 'Albumine (mg/l)', 'timeFrame': 'Change from baseline after 10 weeks', 'description': 'Albumine (24 h urine)'}, {'measure': 'Selenium (µmol/24 h)', 'timeFrame': 'Change from baseline after 10 weeks', 'description': 'Selenmium (24 h urine)'}, {'measure': 'Zinc (µmol/24 h)', 'timeFrame': 'Change from baseline after 10 weeks', 'description': 'Zinc (24 h urine)'}], 'primaryOutcomes': [{'measure': 'Triacylglcerides, mmol/l (group A, B)', 'timeFrame': 'Change from baseline after 10 weeks', 'description': 'Cardiovascular risk factor'}, {'measure': 'Fasting glucose, mmol/l (group C, D)', 'timeFrame': 'Change from baseline after 10 weeks', 'description': 'Diabetes risk factor'}], 'secondaryOutcomes': [{'measure': 'Total cholesterol (mmol/l)', 'timeFrame': 'Change from baseline after 10 weeks', 'description': 'Cardiovascular risk factor'}, {'measure': 'HDL cholesterol (mmol/l)', 'timeFrame': 'Change from baseline after 10 weeks', 'description': 'Cardiovascular risk factor'}, {'measure': 'LDL cholesterol (mmol/l)', 'timeFrame': 'Change from baseline after 10 weeks', 'description': 'Cardiovascular risk factor'}, {'measure': 'Systolic pressure (mm Hg)', 'timeFrame': 'Change from baseline after 10 weeks', 'description': 'Cardiovascular risk factor'}, {'measure': 'Diastolic pressure (mm Hg)', 'timeFrame': 'Change from baseline after 10 weeks', 'description': 'Cardiovascular risk factor'}, {'measure': 'Insulin (mU/l)', 'timeFrame': 'Change from baseline after 10 weeks', 'description': 'Diabetes risk factor'}, {'measure': 'HbA1c (%)', 'timeFrame': 'Change from baseline after 10 weeks', 'description': 'Diabetes risk factor'}, {'measure': 'Body weight (kg)', 'timeFrame': 'Change from baseline after 10 weeks', 'description': 'Cardiovascular risk factor'}, {'measure': 'Body fat (kg)', 'timeFrame': 'Change from baseline after 10 weeks', 'description': 'Cardiovascular risk factor'}, {'measure': 'High sensitive c-reactive protein (mg/l)', 'timeFrame': 'Change from baseline after 10 weeks', 'description': 'Inflammatory marker'}, {'measure': 'Fatty acid distribution in erythrocyte lipids (% fatty acid methyl esters)', 'timeFrame': 'Change from baseline after 10 weeks', 'description': 'Fatty acid distribution in erythrocyte lipids'}, {'measure': 'Vitamin A (mmol/l)', 'timeFrame': 'Change from baseline after 10 weeks', 'description': 'Vitamins'}, {'measure': 'Vitamin D (nmol/l)', 'timeFrame': 'Change from baseline after 10 weeks', 'description': 'Vitamins'}, {'measure': 'Vitamin E (µmol/l)', 'timeFrame': 'Change from baseline after 10 weeks', 'description': 'Vitamins'}, {'measure': 'Vitamin B1 (nmol/l)', 'timeFrame': 'Change from baseline after 10 weeks', 'description': 'Vitamins'}, {'measure': 'Vitamin B6 (nmol/l)', 'timeFrame': 'Change from baseline after 10 weeks', 'description': 'Vitamins'}, {'measure': 'Vitamin B12 (pmol/l)', 'timeFrame': 'Change from baseline after 10 weeks', 'description': 'Vitamins'}, {'measure': 'Holo-transcobalamin (pmol/l)', 'timeFrame': 'Change from baseline after 10 weeks', 'description': 'Vitamins'}, {'measure': 'Folic acid (µg/l)', 'timeFrame': 'Change from baseline after 10 weeks', 'description': 'Vitamins'}, {'measure': 'Vitamin H (ng/l)', 'timeFrame': 'Change from baseline after 10 weeks', 'description': 'Vitamins'}, {'measure': 'Vitamin C (mg/l)', 'timeFrame': 'Change from baseline after 10 weeks', 'description': 'Vitamins'}, {'measure': 'Potassium (mmol/l)', 'timeFrame': 'Change from baseline after 10 weeks', 'description': 'Minerals and trace elements'}, {'measure': 'Iron (µmol/l)', 'timeFrame': 'Change from baseline after 10 weeks', 'description': 'Minerals and trace elements'}, {'measure': 'Ferritin (µg/l)', 'timeFrame': 'Change from baseline after 10 weeks', 'description': 'Minerals and trace elements'}, {'measure': 'Transferrin (g/l)', 'timeFrame': 'Change from baseline after 10 weeks', 'description': 'Minerals and trace elements'}, {'measure': 'Iodine (µmol/l)', 'timeFrame': 'Change from baseline after 10 weeks', 'description': 'Minerals and trace elements'}, {'measure': 'Selenium (µmol/l)', 'timeFrame': 'Change from baseline after 10 weeks', 'description': 'Minerals and trace elements'}, {'measure': 'Zinc (µmol/l)', 'timeFrame': 'Change from baseline after 10 weeks', 'description': 'Minerals and trace elements'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['triacylglcerides, glucose, HbA1c, body weight'], 'conditions': ['Decreased Cardovascular Risk', 'Decreased Risk of Diabetes Mellitus Type II']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.nuco.uni-jena.de/studien', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The proposed intervention study addresses the development and validation of nutritional concepts based on menu plans for patients with hypertriglyceridemia (triglycerides \\> 1.5 mmol/l) and participants with impaired glucose tolerance/prediabetes (glucose \\> 5.6 ≤ 7 mmol/l).', 'detailedDescription': 'The proposed intervention study addresses the development and validation of nutritional concepts for patients with hypertriglyceridemia (triglycerides \\> 1.5 mmol/l) and participants with impaired glucose tolerance (glucose \\> 5.6 ≤ 7 mmol/l).\n\nThe randomized, controlled study will be conducted in a parallel design with four arms. In total, 120 participants (males, females; age: 30 - 80 years) will be randomized to one of the four groups: hypertriglyceridemia concept (group A), hypertriglyceridemia control (group B), prediabetes concept (group C), and prediabetes control (group D).\n\nThe study participants in group A and C receive defined personal nutritional counselling every two weeks and they are provided with daily menu plans (isocaloric) with optimized nutrient profiles and chosen study products (e.g., fish or plant oil, nuts) over the study period of ten weeks. Participants in the control groups B and D are not provided with defined menu plans or study products.\n\nBlood samples will be taken at the beginning, regularly every two weeks of the ten-weeks intervention period as well as after the ten-weeks follow-up. Primary endpoints are triglycerides (group A, B), and fasting glucose (group C, D).\n\nThe study design enables the comparison of the effectiveness of the developed nutritional concepts, which were adapted to the requirements of the target groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nVoluntary participation with documented consent\n\n* Willingness and ability to adhere to study protocol\n* Volunteer test person (m/f) aged ≥ 30 years and ≤ 80 years\n* BMI: ≥ 20 ≤ 40 kg/m2\n* No or moderate alcohol consumption (≤ 2 glasses/week)\n* non-smoker (if possible)\n* Group A, B: triglycerides: \\> 1.5 mmol/l\n* Group C, D: Fasting glucose: ≥ 5.6 ≤ 7 mmol/L\n\nExclusion Criteria:\n\nConcomitant diseases:\n\n* Hypercholesterolemia (genetic defect / familial predisposition)\n* Diabetes mellitus\n* Thyroid dysfunction (hyper- or hypothyroidism)\n* Food intolerances/allergies to ingredients in the study foods\n* Medications: lipid-lowering drugs, glucocorticoids, oral medication for the treatment of type 1-4 diabetes mellitus, insulin injections\n* Dietary supplements: especially n-3 fatty acids, vitamin E\n* Extremely high physical activity (daily)\n* Alcohol abuse (daily)\n* (smokers) \\[if there are not enough subjects available, at least 7 smokers should be included so that a statistical analysis is possible\\]\n* Uncontrolled organic diseases\n* Alcohol, medication or drug abuse\n* Participation in other observational clinical studies during or 4 wk. before starting this study\n* Severe behavioral, emotional, or psychiatric problems that the investigator determined would result in non-compliance\n* Pregnancy, lactation and unsafe contraception\n* Other reasons considered important by the investigator'}, 'identificationModule': {'nctId': 'NCT05382533', 'acronym': 'MoKaRi II', 'briefTitle': 'MoKaRi II Intervention Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Jena'}, 'officialTitle': 'Modulation of Cardiovascular Risk II (MoKaRi II) Intervention Study - Modulation of Cardiovascular Risk and Diabetes Risk Using Menu Plans', 'orgStudyIdInfo': {'id': 'H13-22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hypertriglyceridemia intervention (group A)', 'description': '* Carbohydrates: ≤ 50 en% (sucrose + glucose + fructose ≤ 10 en%, where sucrose ≤ 5 en% and fructose ≤ 20 g/d)\n* Fat: 30-35 En%\n* Protein: 20 En%\n* marine n3 PUFA (EPA/DHA): ≥ 4000 mg/d (10 g fish oil)', 'interventionNames': ['Dietary Supplement: Menu plans']}, {'type': 'NO_INTERVENTION', 'label': 'Hypertriglyceridemia control (group B)', 'description': 'no menu plans, no study foods'}, {'type': 'EXPERIMENTAL', 'label': 'Prediabetes intervention (group C)', 'description': '* Carbohydrates: 40 ± 2 En%\n* Sucrose + glucose + fructose ≤ 10 En%\n* Free sugars \\< 5% of daily energy\n* Fat: 40 ± 2%\n* Protein: 20 ± 2 En%\n* n3 PUFA: ≥ 500 mg/d', 'interventionNames': ['Dietary Supplement: Menu plans']}, {'type': 'NO_INTERVENTION', 'label': 'Prediabetes control (group D)', 'description': 'no menu plans, no study foods'}], 'interventions': [{'name': 'Menu plans', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The study participants in group A and C receive defined personal nutritional counselling every two weeks and they are provided with daily menu plans (isocaloric) with optimized nutrient profiles and chosen study products (plant oils, nuts mixture etc.) over the study period of 10 weeks.', 'armGroupLabels': ['Hypertriglyceridemia intervention (group A)', 'Prediabetes intervention (group C)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07743', 'city': 'Jena', 'state': 'Thuringia', 'country': 'Germany', 'facility': 'Institute of Nutritional Sciences', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}], 'overallOfficials': [{'name': 'Christine A Dawczynski, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Friedrich Schiller University Jena'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Jena', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Christine Dawczynski,PhD', 'investigatorAffiliation': 'University of Jena'}}}}