Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-02-22 @ 5:08 PM
Study NCT ID:
NCT02028702
Status:
COMPLETED
Last Update Posted:
2015-02-06
First Post:
2012-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alternative Treatments for Menopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019584', 'term': 'Hot Flashes'}, {'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-05', 'studyFirstSubmitDate': '2012-07-12', 'studyFirstSubmitQcDate': '2014-01-06', 'lastUpdatePostDateStruct': {'date': '2015-02-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Menopause-related symptoms', 'timeFrame': '3 months', 'description': 'To examine the extent to which red clover extract can reduce the frequency and intensity of hot flashes, sleep disturbances and flush related sweats.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['red clover', 'menopause', 'bioactive compounds', 'isoflavones', 'phytoestrogen'], 'conditions': ['Menopause', 'Hot Flushes', 'Osteoporosis', 'Dyslipidemia']}, 'referencesModule': {'references': [{'pmid': '28591133', 'type': 'DERIVED', 'citation': 'Lambert MNT, Thorup AC, Hansen ESS, Jeppesen PB. Combined Red Clover isoflavones and probiotics potently reduce menopausal vasomotor symptoms. PLoS One. 2017 Jun 7;12(6):e0176590. doi: 10.1371/journal.pone.0176590. eCollection 2017.'}]}, 'descriptionModule': {'briefSummary': 'To investigate the reported health benefits (lipid profile, inflammatory factors, cardiovascular status and bone density) of a novel, phytoestrogen rich, Red Clover treatment on women suffering from both menopause related primary (hot flushes, night sweats, sleep disturbance and weight gain) and secondary (osteoporosis, cardiovascular and changes in lipid metabolism) symptoms.', 'detailedDescription': "Menopausal symptoms are a common phenomenon causing discomfort to many middle aged women throughout the world. The core symptoms are experienced as hot flushes (HF), night sweats, vaginal dryness and sleep disturbance. Other secondary symptoms are sexual dysfunction, depression, anxiety, memory loss, fatigue, headache, joint pains and weight gain. Moreover there is increased risk of further complications such as osteoporosis, cardiovascular and negative changes in lipid profile associated with the reduction in oestrogen during and post menopause.\n\nTrifolium Pratense or Red Clover (RC) has arisen as a popular source for women experiencing HF because it contains a variety of phytoestrogen's, namely isoflavones, lignans and coumestans. Phytoestrogens are shown to have positive effects on menopausal disorders such as breast cancer, cardiovascular risk factors, osteoporosis and have been shown to exert non-hormonal antioxidant effects. Additionally these isoflavones appear to reduce bone resorbtion, help maintain bone mineral density and improve lipid profile (reducing LDL: HDL, lipoprotein A, total cholesterol and may also reduce triglycerides).\n\nRC is particularly high in estrogenic isoflavones biochanin A, formononetin and to a lesser degree genestein and diadzein, although the two former are precursors to genestein and diadzein. Asian populations with a high intake of soy (rich in genestein and diadzein) have long shown a lower reported incidence of the symptoms of menopause.\n\nThe study will be carried out as a 3-month parallel randomized control intervention study, consisting of 61 menopausal women. During summer 2012, 61 participants will be randomised into 2 groups (\\~30-31 in each group). The two groups are as follows:\n\n1. Menopausal women receiving RC treatment - 150ml/d Red Clover (80mg/d of isoflavones as aglycone)\n2. Menopausal women receiving placebo - 150ml placebo"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 40-65 years\n* Experiencing daily hot flushes\n* Body Mass Index (BMI) between 20-40\n* Irregular menstrual bleeding\n* FSH levels above the normal range\n\nExclusion Criteria:\n\n* Simultaneous participation in other clinical trials within the last 3 months\n* Severe cardiovascular, psychiatric, neurological, and/or kidney disease.\n* Alcohol or drug abuse and acute illness.\n* Blood pressure \\> 160/110\n* Pregnant and lactating women'}, 'identificationModule': {'nctId': 'NCT02028702', 'briefTitle': 'Alternative Treatments for Menopausal Women', 'organization': {'class': 'OTHER', 'fullName': 'Aarhus University Hospital'}, 'officialTitle': 'Alternative Treatments for Menopausal Women: The Efficacy of a Novel Red Clover Treatment on Menopausal Women.', 'orgStudyIdInfo': {'id': 'Mntl-1877'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Red Clover extract', 'description': '150 ml/d Red Clover extract', 'interventionNames': ['Dietary Supplement: Red Clover extract']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '150 ml/d sweetened and coloured water', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'water with color', 'armGroupLabels': ['Placebo']}, {'name': 'Red Clover extract', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['fermentated Red Clover extract'], 'description': 'Red Clover extract containing 80 mg Isoflavones. Dosage: 2 X 75 ml/day', 'armGroupLabels': ['Red Clover extract']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9800', 'city': 'Hjørring', 'state': 'North Denmark', 'country': 'Denmark', 'facility': 'Center for Clinical Research, Hospital Vendsyssel', 'geoPoint': {'lat': 57.46417, 'lon': 9.98229}}], 'overallOfficials': [{'name': 'Per B Jeppesen, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aarhus University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Prof., PhD', 'investigatorFullName': 'Per Bendix Jeppesen', 'investigatorAffiliation': 'Aarhus University Hospital'}}}}