[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657755":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":29,"studyPopulation":17,"armGroups":30,"interventions":43,"overallOfficials":55,"centralContacts":60,"locations":69,"responsibleParty":109,"collaborators":17,"id":111,"slug":112,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":119,"sex":120,"minAge":121,"maxAge":122,"enrollmentInfo":123,"targetDuration":17,"studyType":126,"phases":127,"briefSummary":129,"conditions":130,"keywords":17,"overallStatus":72,"whyStopped":17,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"fullName":5,"class":6},"Sam Houston State University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Skeletal Muscle Protein Degradation","Primary outcomes will be changes in urinary N-fragment of titin and serum 3-methylhistidine between supplementation and placebo conditions. Paired t-tests or linear mixed-effects models will be used to account for within-subject crossover effects. Hormone levels will be included as covariates. Statistical significance will be set at p \\\u003C 0.05.","48 hours",[14],{"measure":15,"description":16,"timeFrame":12},"Decrease protein degradation","We would like to home in on protein intake and degradation to quantify the amount of protein loss seen during the luteal phase, the point at which protein degradation is deemed to be the highest. Our specific aims for this project will be to 1) quantify protein degradation at the time of the luteal phase and 2) determine whether targeted protein supplementation during the luteal phase will reduce measured protein degradation. We anticipate there will be an advantageous, decreased catabolic effect with increasing protein intake during the luteal phase.\n\nTo measure this, we will use Blood and Urine samples during the menstrual cycle.\n\nBlood Samples:\n\nBlood will be collected in serum separator tubes (SST)\n\nSerum will be analyzed using enzyme-linked immunosorbent assay (ELISA) methods to measure:\n\n3-Methylhistidine Progesterone\n\nUrine Samples:\n\nUrine samples will be analyzed using ELISA methods to measure:\n\nN-fragment of Titin Creatin",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":17,"primaryPurpose":21,"observationalModel":17,"timePerspective":17,"maskingInfo":22},"RANDOMIZED","CROSSOVER","TREATMENT",{"masking":23,"maskingDescription":17,"whoMasked":24},"QUADRUPLE",[25,26,27,28],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","The physiologic effects of the female menstrual cycle have been shown to cause many changes to metabolic processes throughout the body depending on the phase of the cycle. For example, during the follicular phase, increase in estrogen aids in arterial vasodilation, lipid metabolism, neuroprotection, and maintaining bone density (Gruber et al. 2002). During the luteal phase, the increase in progesterone aids in thermoregulation, increased respiration, and basal insulin levels (Taraborrelli 2015). However, there is conflicting evidence regarding net progesterone effects on skeletal muscle. Some studies state that progesterone has an anabolic effect while others suggest the contrary. Despite the discrepancies with current literature, Sims et al. recommends female athletes increase their protein intake by 12% during the luteal phase of their menstrual cycle to potentially counteract the protein catabolic effects of progesterone on skeletal muscle (2023). The basis of this conclusion was based on invitro and in vivo studies showing decreases amino acids during the luteal phase (Faustmann et al. 2018 \\& Draper et al. 2018)\n\nTo our knowledge, no study exists that analyzes protein degradation with protein supplementation increase during the luteal phase. The purpose of this research is to determine if increasing 12% of daily protein intake during the luteal phase mitigates the potential catabolic effects of progesterone on skeletal muscle. This research could help determine if millions of women would benefit from additional protein supplementation during the luteal phase, which may lead to decreased skeletal muscle atrophy over time. We anticipate there will be an advantageous, decreased catabolic effect with increasing protein intake during the luteal phase.",[31,37],{"label":32,"type":33,"description":34,"interventionNames":35},"A","ACTIVE_COMPARATOR","Will receive protein supplement",[36],"Dietary Supplement: protein supplement",{"label":38,"type":39,"description":40,"interventionNames":41},"B","PLACEBO_COMPARATOR","Will receive placebo supplement",[42],"Dietary Supplement: Placebo",[44,50],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"DIETARY_SUPPLEMENT","protein supplement","Protein supplementation during progesterone peak to stop protein degradation effect.",[32],[32],{"type":45,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"Placebo","Will receive placebo supplementation",[38],[38],[56],{"name":57,"affiliation":58,"role":59},"Patrick Davis, PhD","SHSU COM","PRINCIPAL_INVESTIGATOR",[61,66],{"name":62,"role":63,"phone":64,"phoneExt":17,"email":65},"Kyndal Kutac","CONTACT","979-743-1135","kbk016@shsu.edu",{"name":67,"role":63,"phone":17,"phoneExt":17,"email":68},"Damian Chiandussi, MD","dac150@shsu.edu",[70,99],{"facility":71,"status":72,"city":73,"state":74,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"SHSU College of Osteopathic Medicine","RECRUITING","Conroe","Texas","77304","United States","US",{"type":79,"coordinates":80},"Point",[81,82],-95.45605,30.31188,{"lat":82,"lon":81},[85,86,88,90,92,94,96,98],{"name":62,"role":63,"phone":64,"phoneExt":17,"email":65},{"name":67,"role":63,"phone":87,"phoneExt":17,"email":68},"936-202-5279",{"name":62,"role":89,"phone":17,"phoneExt":17,"email":17},"SUB_INVESTIGATOR",{"name":91,"role":89,"phone":17,"phoneExt":17,"email":17},"Maniola Olawoye",{"name":93,"role":89,"phone":17,"phoneExt":17,"email":17},"Maddison Vrazel",{"name":95,"role":89,"phone":17,"phoneExt":17,"email":17},"Michelle Greene",{"name":97,"role":89,"phone":17,"phoneExt":17,"email":17},"Damian Chiandussi",{"name":57,"role":59,"phone":17,"phoneExt":17,"email":17},{"facility":100,"status":101,"city":73,"state":74,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":102,"geoPoint":104,"contacts":105},"SHSU Physician's Clinic","NOT_YET_RECRUITING",{"type":79,"coordinates":103},[81,82],{"lat":82,"lon":81},[106,107,108],{"name":62,"role":63,"phone":64,"phoneExt":17,"email":65},{"name":67,"role":63,"phone":87,"phoneExt":17,"email":68},{"name":57,"role":59,"phone":17,"phoneExt":17,"email":17},{"type":110,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100657755","protein-supplementation-during-luteal-phase-to-stop-protein-degradation-100657755",false,"NCT07843095","Protein Supplementation During Luteal Phase to Stop Protein Degradation","Protein Supplementation During Luteal Phase","Protein","Inclusion Criteria:\n\n* Eumenorrheic\n* 18 to 35 years old\n\nExclusion Criteria:\n\n* Pregnant or lactating (These individuals will not have a regular menstrual cycle) in the previous six months\n* Vegetarian (protein supplementation is from animal origin)\n* Contraceptive use, any hormone based contraceptive use for 6 months prior to enrollment\n* Use of illicit drugs in previous 6 months.\n* Non-tobacco user\n* Gasterointestinal disorders, liver disease, infectious disease, cardiovascular, pulmonary, renal, immune, metabolic, cancer\n* Medications: corticosteroids, chronic NSAIDS, high strength acne, testosterone\n* Diagonsed PCOS, endometrosis, ovarian insufficency, or other menstrual cycle disorder.",true,"FEMALE","18 Years","35 Years",{"count":124,"type":125},34,"ESTIMATED","INTERVENTIONAL",[128],"NA","The purpose of this research is to determine if increasing 12% of daily protein intake during the luteal phase mitigates the potential catabolic effects of progesterone on skeletal muscle. We anticipate there will be an advantageous, decreased catabolic effect with increasing protein intake during the luteal phase.\n\nBy doing this study, we hope to learn if millions of women would benefit from additional protein supplementation during the luteal phase, which may lead to decreased skeletal muscle atrophy over time. Your participation in this research will last about 4 months.",[131],"Muscle Atrophy","2026-09-22",{"date":134,"type":135},"2026-09-25","ACTUAL",{"date":137,"type":135},"2026-08-04",{"date":139,"type":125},"2027-01-29",{"name":5,"class":6},2]