Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2025-12-27 @ 12:14 AM
Study NCT ID:
NCT01407692
Status:
COMPLETED
Last Update Posted:
2017-12-05
First Post:
2011-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Menstrual Cycle Hormones and Eating Behavior
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D005518', 'term': 'Food Preferences'}], 'ancestors': [{'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum, plasma and urine samples may be retained for future testing.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-01', 'studyFirstSubmitDate': '2011-07-26', 'studyFirstSubmitQcDate': '2011-07-29', 'lastUpdatePostDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eating behavior', 'timeFrame': 'At follicular (day 11) and luteal (day 26) phase of menstrual cycle', 'description': 'Eating behavior, including types of foods preferred, wanting/desire for specific foods, and perception of hunger will be measured using four questionnaires; Eating inventory: to assess dietary restraint, Stanford Brief Physical Activity Questionnaire, Food craving questionnaire, Eating behavior and attitudes questionnaire'}], 'secondaryOutcomes': [{'measure': 'Insulin sensitivity', 'timeFrame': 'At follicular (day 11) and luteal (day 26) phase of menstrual cycle', 'description': 'To determine if the phase of the menstrual cycle affects insulin sensitivity, we will measure plasma insulin, glucose and non-esterified fatty acids (NEFA).'}, {'measure': 'Serum lipid profile changes', 'timeFrame': 'At follicular (day 11) and luteal (day 26) phase of menstrual cycle', 'description': 'Blood samples will be analyzed for lipids and lipoproteins, including apoproteins A1, B, C-II, C-III, and E.'}, {'measure': 'Urinary c-peptide', 'timeFrame': 'At follicular (day 11) and luteal (day 26) phase of menstrual cycle', 'description': 'The level of urinary C-peptide and creatinine will be measured in a 24-hour urine collection.'}, {'measure': 'Estradiol', 'timeFrame': 'At follicular (day 11) and luteal (day 26) phase of menstrual cycle', 'description': 'Estradiol measured in serum in relation to appetite variables'}, {'measure': 'progesterone', 'timeFrame': 'At follicular (day 11) and luteal (day 26) phase of menstrual cycle', 'description': 'Progesterone measured in serum in relation to appetite variables'}, {'measure': 'Dehydroepiandrosterone (DHEA)', 'timeFrame': 'At follicular (day 11) and luteal (day 26) phase of menstrual cycle', 'description': 'Dehydroepiandrosterone measured in serum in relation to appetite variables'}, {'measure': 'Sex Hormone Binding Globulin (SHBG)', 'timeFrame': 'At follicular (day 11) and luteal (day 26) phase of menstrual cycle', 'description': 'SHBG measured in serum in relation to appetite variables'}, {'measure': 'Endocannabinoid profile', 'timeFrame': 'At follicular (day 11) and luteal (day 26) phase of menstrual cycle', 'description': 'Endocannabinoid profile measured in serum to assess appetite'}, {'measure': 'Leptin', 'timeFrame': 'At follicular (day 11) and luteal (day 26) phase of menstrual cycle', 'description': 'Leptin measured in serum to assess appetite'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['menstrual cycle', 'estrogen'], 'conditions': ['Dietary Habits', 'Food Preference']}, 'referencesModule': {'references': [{'pmid': '30031087', 'type': 'DERIVED', 'citation': 'Krishnan S, Agrawal K, Tryon RR, Welch LC, Horn WF, Newman JW, Keim NL. Structural equation modeling of food craving across the menstrual cycle using behavioral, neuroendocrine, and metabolic factors. Physiol Behav. 2018 Oct 15;195:28-36. doi: 10.1016/j.physbeh.2018.07.011. Epub 2018 Jul 18.'}, {'pmid': '27527001', 'type': 'DERIVED', 'citation': 'Krishnan S, Tryon RR, Horn WF, Welch L, Keim NL. Estradiol, SHBG and leptin interplay with food craving and intake across the menstrual cycle. Physiol Behav. 2016 Oct 15;165:304-12. doi: 10.1016/j.physbeh.2016.08.010. Epub 2016 Aug 12.'}], 'seeAlsoLinks': [{'url': 'https://www.ars.usda.gov/pacific-west-area/davis-ca/whnrc/', 'label': 'United States Department of Agriculture, ARS, Western Human Nutrition Research Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if the phase of the menstrual cycle (opposed versus unopposed estrogen phase) affects eating behavior, including types of foods preferred, wanting/desire for specific foods, and perception of hunger.', 'detailedDescription': 'This is an observational study to investigate the effect of endogenous estrogen (E2) and progesterone (P4) levels on eating behavior and energy-yielding nutrient metabolism. Eating behavior will be assessed during a complete menstrual cycle during the first month of the study. Participants will track the follicular and luteal phases of their menstrual cycle using urinary leuteinizing hormone (LH) kits, they will record information about their food intake, eating behaviors, and appetite in their home environments, and they will complete two laboratory test days: one test day scheduled during their follicular phase, and one test day scheduled during their luteal phase.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy, premenopausal women.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index between 20-30 Kg/m2\n* regular menstrual cycles\n* sedentary lifestyle (physical activity not more than 30 minutes per day three times a week)\n\nExclusion Criteria:\n\n* Fasting blood sugar greater than 110 mg/dL\n* Systolic Blood Pressure greater than 140 mmHg\n* Diastolic Blood Pressure greater than 90 mmHg\n* Fasting triglycerides greater than 120 mg/dL\n* Documented or self-reported chronic disorders such as arthritis, or other inflammatory diseases\n* Women who are Post-menopausal or Peri-menopausal\n* Pre-menopausal women who are pregnant, uni/multiparous, taking oral contraceptives, or who have menstrual cycles lasting less than 20 days or greater than 45 days, polycystic ovary syndrome (PCOS), amenorrhea, eumenorrhoea, or polymenorrhoea.'}, 'identificationModule': {'nctId': 'NCT01407692', 'acronym': 'FL-84', 'briefTitle': 'Menstrual Cycle Hormones and Eating Behavior', 'organization': {'class': 'FED', 'fullName': 'USDA, Western Human Nutrition Research Center'}, 'officialTitle': 'Effect of Menstrual Cycle Hormone Changes on Eating Behavior and Nutrient Metabolism', 'orgStudyIdInfo': {'id': 'WHNRC 221594-1'}}, 'contactsLocationsModule': {'locations': [{'zip': '95616', 'city': 'Davis', 'state': 'California', 'country': 'United States', 'facility': 'USDA, ARS, Western Human Nutrition Research Center', 'geoPoint': {'lat': 38.54491, 'lon': -121.74052}}], 'overallOfficials': [{'name': 'Nancy Keim, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'USDA, ARS, Western Human Nutrition Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'USDA, Western Human Nutrition Research Center', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}