Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-01-02 @ 1:54 AM
Study NCT ID:
NCT07227766
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-14
First Post:
2025-11-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dietary Reversal of the Reprometabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D007247', 'term': 'Infertility, Female'}, {'id': 'D007246', 'term': 'Infertility'}], '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': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018752', 'term': 'Diet, Fat-Restricted'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2029-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-12', 'studyFirstSubmitDate': '2025-11-11', 'studyFirstSubmitQcDate': '2025-11-11', 'lastUpdatePostDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urinary Pregnadiol Glucouronide concentration in ug/mg creatinine', 'timeFrame': 'From enrollment for 4 months post enrollment'}], 'secondaryOutcomes': [{'measure': 'Amount of Urinary estrogen', 'timeFrame': 'From enrollment to 4 months', 'description': 'Urinary estrogen concentration in microgram/mg of Creatinine'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Infertility', 'Reproductive Hormones', 'Low-Fat Diet', 'Obesity', 'Hypothalamic-pitutary-ovarian axis'], 'conditions': ['Obesity & Overweight', 'Infertility, Female']}, 'descriptionModule': {'briefSummary': 'This study proposes to test the specific question that a eucaloric, low-fat diet given to women with obesity will result in an increase in reproductive hormones.', 'detailedDescription': 'This an open-label, multi site study in pre-menopausal women aged 18-40 years old with a history of regular menstrual cycles (25-35 days long) of high BMI. The objective of the study will be to determine the effects of a one month long, eucaloric low-fat diet on reproductive hormone levels in women with a high BMI. The study will occur over 4 menstrual cycle (approximately 4 months). During the study the participants will have a pre-diet cycle where no food will be consumed, an on-diet cycle where the customized low-fat diet will be consumed, and two post diet cycles. First morning voided urine will be collected during all four cycles along with 3 blood draws during the study. Participants will be asked to use a reliable barrier method of birth control or abstain from intercourse during the study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'This study examines female reproductive hormones.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal TSH and prolactin\n* Regular menstrual cycles every 25-40 days\n* No history of chronic disease affecting hormone production, metabolism or clearance\n* No use of reproductive hormones, or medications/supplements known to impact them, within 3 months of enrollment\n* Use of a reliable method of contraception (female or male partner sterilization, IUD, abstinence, diaphragm or cervical cap)\n* Normal ovarian reserve (AMH of 0.5ng/ml or greater)\n* Normal testosterone levels at screening or absence of clinical evidence of hyperandrogenemia (acne, facial hirsutism \\[defined as Ferriman-Gallwey score\\>8\\] or alopecia)\n\nExclusion Criteria:\n\n* Baseline dietary assessment indicative of 28% or less daily calories from fat\n* Inability to comply with the protocol (many meals per week eaten outside of the home, frequent travel)\n* Pregnancy or planned pregnancy within next 6 months at time of screening\n* HbA1C \\>6.5%'}, 'identificationModule': {'nctId': 'NCT07227766', 'acronym': 'LFD', 'briefTitle': 'Dietary Reversal of the Reprometabolic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Dietary Reversal of the Reprometabolic Syndrome', 'orgStudyIdInfo': {'id': '23-1702'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low-Fat Diet', 'description': 'Participants will eat a customized, eucaloric low-fat diet for one month', 'interventionNames': ['Dietary Supplement: Low-fat diet']}], 'interventions': [{'name': 'Low-fat diet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will eat a one-month eucaloric high-fat diet.', 'armGroupLabels': ['Low-Fat Diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado School of Medicine', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Nanette Santoro, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}