[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Pharmanutra S.p.a.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":123},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,76,101],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100623186","effect-of-a-food-for-special-medical-purposes-on-muscle-mass-preservation-during-glp-1-ras-weight-loss-treatment-100623186",false,"NCT07393360","Effect of a Food for Special Medical Purposes on Muscle Mass Preservation During GLP-1 RAs Weight Loss Treatment","Evaluating the Effect of a Food for Special Medical Purposes Containing Essential Amino Acids (EAA), Carnitine, Arginine, and Sucrosomial Minerals on the Preservation of Appendicular Skeletal Muscle Mass (ASMM) During a Weight Loss Program With GLP-1 Receptor Agonists","MYO-PRESERVE","Inclusion Criteria:\n\n* Age ≥18 years and ≤ 65 years old;\n* BMI ≥ 30 Kg\u002Fm2 and ≤45 kg\u002Fm2\n* BMI from 27 kg\u002Fm2 to 30 Kg\u002Fm2 with at least one associated co-morbidity related to overweight \\[e.g. dysglycemia (pre-diabetes and\u002For metabolic syndrome), hypertension, dyslipidemia, obstructive sleep apnea syndrome (OSAS\\], or cardiovascular disease\\]\n* Starting to use a GLP-1 RAs (liraglutide, semaglutide) or dual GIP and GLP-1 RAs (tirzepatide) for weight reduction; patient can be enrolled if they start the treatment at the time of enrollment or up to 2 weeks\n* Diet composition adjusted to provide 0.9-1.1 g\u002FKg ideal body weight proteins\n* Signed informed consent\n\nExclusion Criteria:\n\n* Type I and Type II diabetes; patients with pre-diabetes and\u002For metabolic syndrome and assuming Metformin and SGLT-2 inhibitors can be enrolled\n* Monogenic obesity (Subjects with a known diagnosis of monogenic obesity, including but not limited to pathogenic mutations in LEP, LEPR, MC4R, POMC, PCSK1, or other genes known to cause monogenic forms of early-onset or syndromic obesity)\n* Reduced kidney function, defined as eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m², calculated using the CKD-EPI equation (see Appendix 1)\n* Oncologic patients in active treatments\n* Hypersensitivity to any of the constituents of the study product\n* Pregnancy\n* Breastfeeding\n* Use of meal replacements for a diet enriched with aminoacids and\u002For HMB\n* Use of food supplements containing aminoacids and\u002For HMB; patients can be included in the study if they undergo a washout period of at least 15 days","ALL","18 Years","65 Years",{"count":21,"type":22},144,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study evaluates whether a Food for Special Medical Purposes (FSMP) can help to preserve appendicular skeletal muscle mass (ASMM) in adults undergoing weight loss treatment with GLP-1 receptor agonists or dual GIP\u002FGLP-1 receptor agonists. Participants will receive the FSMP or a matching placebo for 24 weeks while continuing standard GLP-1-based therapy. ASMM will be measured using Bioelectrical Impedance Vector Analysis (BIVA).",[28],"Obesity & Overweight",[30,31,32,33,34],"Weight Loss","Muscle Mass Preservation","Obesity","Body Composition","BIVA","RECRUITING","2026-03-20",{"date":38,"type":39},"2026-03-23","ACTUAL",{"date":41,"type":39},"2025-12-11",{"date":43,"type":22},"2026-12",{"name":45,"class":46},"Pharmanutra S.p.a.","INDUSTRY",3,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":56,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100616681","phase-4-efficacy-and-tolerability-of-sucrosomial-iron-vs-ferric-maltol-in-iron-deficient-women-100616681","NCT07308769","Efficacy and Tolerability of Sucrosomial® Iron vs Ferric Maltol in Iron Deficient Women","A Prospective, Open-Label, Randomized, Interventional Study to Evaluate the Efficacy and Tolerability of Sucrosomial® Iron vs Ferric Maltol in Iron Deficient Women","SID-WOMEN","Inclusion Criteria:\n\n* Female participants ≥ 18 years\n* Mild anemia (11.0 ≤ Hb \\\u003C 12 g\u002FdL) or moderate anemia (8.0 \\\u003C Hb \\\u003C 11 g\u002FdL)\n* Signed informed consent\n\nExclusion Criteria:\n\n* Use of iron-containing drugs or supplements within 1 month prior to screening\n* Psychiatric disorders interfering with consent or compliance\n* Active cancer (except fibroids and polyps)\n* Pregnant or breastfeeding women\n* Participation in another interventional study\n* History of poor adherence or inability to comply\n* Use of erythropoietin within 3 months prior to screening\n* Need for blood transfusion or IV iron (per investigator judgment)\n* Severe active IBD (HBI \\> 16 for Crohn; CAI \\> 12 for ulcerative colitis)\n* Previous bariatric surgery\n* Alcohol abuse\n* Hemochromatosis or iron overload syndromes\n* Hereditary anemias (including thalassemia)\n* Known hypersensitivity to study product ingredients","FEMALE",{"count":58,"type":22},146,[60],"PHASE4","This study aims to compare two oral iron treatments, Sucrosomial® Iron and Ferric Maltol, in women with mild to moderate iron deficiency anemia. Many patients experience gastrointestinal side effects or poor tolerability with traditional iron supplements, which may limit adherence. Participants will be randomly assigned to receive either Sucrosomial® Iron or Ferric Maltol for 12 weeks. The primary objective is to determine whether Sucrosomial® Iron is as effective as Ferric Maltol in normalizing hemoglobin levels.",[63,64],"Anemia","Iron Deficiency Anemia (IDA)",[66,67,68,69],"Iron Deficiency","Iron Deficiency Anemia","Mild to Moderate Anemia","anemia in women",{"date":38,"type":39},{"date":41,"type":39},{"date":73,"type":22},"2026-10",{"name":45,"class":46},7,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":23,"phases":87,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},"100615995","oral-supplementation-with-a-formulation-based-on-cetylated-fatty-acids-for-post-fracture-long-bone-healing-100615995","NCT07299851","Oral Supplementation With a Formulation Based on Cetylated Fatty Acids for Post-fracture Long Bone Healing","Randomized, Double-blind, Placebo-controlled Study With 12 Weeks Oral Supplementation With a Formulation Based on Cetylated Fatty Acids to Support the Early Stage of Long Lower Limb Bone Healing After Fracture Stabilization","CETIULTRA-BONE","Inclusion Criteria:\n\n* Between 18 and 85 years old\n* Presence of simple closed unifocal fracture (transverse, oblique, spiral, butterfly-shaped) in a long bone which need a standard of care surgical stabilization\n* Presence of diaphyseal fracture of lower limb (femur or tibia, Subtrochanteric fracture are also allowed)\n* Presence intramedullary nail\n* Weight bearing as tolerated after surgery\n* Having signed an informed consent, understand study procedures and ability to follow them\n* Agreed to stop vitamin D intake for participants who take prophylactic Vitamin D\n\nExclusion Criteria:\n\n* Treatment with vitamin D for medical purpose (Non-union, osteoporosis…)\n* BMI \\> 30\n* Open fracture\n* Intra articular fracture\n* Metaphyseal fracture\n* Polytrauma patient (injury severity score: ISS \\>= 16)\n* More than one lower limb long bone fracture\n* Bridging plate\n* Fracture treated conservatively with plaster\n* Presence of active infection (body temperature ≥ 38°C or other symptoms)\n* Any sign of severe vascular compromise across the fracture site (such as compartment syndrome, presence of serious vascular damage, etc.)\n* Pathological fracture or diseases with a risk of recurrent falling (e.g. Parkinson's disease\u002Fsyndrome, Hemiplegia after stroke, symptomatic stenosis of the spinal canal, polyneuropathy, epilepsy, recurring vertigo, recurring syncope)\n* Participants with known bone disease which would negatively impact on the bone healing process\n* Participants currently being treated with radiation, chemotherapy, immunosuppression, or steroid therapy\n* Diabetic participants\n* Daily smoker participants (cigarette or vaping containing nicotine)\n* Participants under cortisone intake\n* Participants under rheumatic medications intake\n* Allergy or adverse effect of food supplement composition\n* Unwilling or unable to take study medication\n* Chronic drug or alcohol abuse\n* Pregnant or breastfeeding at the time of enrolment\n* Any other investigational treatment or food supplement within 3 months.","85 Years",{"count":86,"type":22},100,[25],"This clinical study aims to evaluate the potential benefits of a formulation based on Cetylated Fatty Acids in improving fracture healing of long bones in the lower limbs. The investigational product is administered orally over a 12-week period. Study procedures are limited to standard imaging techniques (radiography and echography), blood sampling, and completion of validated quality of life questionnaires.",[90,91],"Fracture Femur","Fracture Tibia","2025-12-17",{"date":94,"type":39},"2025-12-23",{"date":96,"type":39},"2025-10-01",{"date":98,"type":22},"2026-06",{"name":45,"class":46},6,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":56,"minAge":18,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":23,"phases":110,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},"100526675","wide-spectrum-micronutrients-supplementation-in-patients-with-cancer-related-fatigue-during-neoadjuvant-and-adjuvant-chemotherapy-100526675","NCT06137833","Wide Spectrum Micronutrients Supplementation in Patients With Cancer Related Fatigue During Neoadjuvant and Adjuvant Chemotherapy","Clinical Study on Wide Spectrum Micronutrients Supplementation in Patients With Cancer Related Fatigue During Neoadjuvant and Adjuvant Chemotherapy","Inclusion Criteria:\n\n1. Females aged 18 or higher.\n2. Patients diagnosed with histologically confirmed breast cancer.\n3. Patients having done at least one cycle of neoadjuvant or adjuvant chemotherapy (independently from type of chemotherapy) and who are on active chemotherapy treatment throughout the duration of the study (\\*).\n4. Patients with ECOG performance status ≤1 at screening.\n5. Patients with cancer related fatigue of moderate-severe intensity (Numerical Rating Scale NRS \\> 4).\n6. Patients able to follow the recommendations on the physical exercise to do.\n7. Patients who accept to use adequate contraceptive methods, if they are of child-bearing potential.\n8. Patients willing and able to give signed informed consent and, in the opinion of the Investigator, to comply with the protocol tests and procedures.\n\n(\\*)Examples of chemotheraphy and standard therapeutic regimens in the neoadjuvant and adjuvant phase in breast cancer and on the basis of the biological characteristics of the neoplasm are as follows:\n\nNeoadjuvant Chemotheraphy\n\n* Epirubicin + Cyclophosphamide, 3 cycles -\\> Taxol\\* weekly for 12 weeks;\n* Epirubicin + Cyclophosphamide -\\> Pertuzumab + Trastuzumab (or Phesgo) 3 cycles + Taxol weekly for 12 weeks;\n* Carboplatin + Taxol\\* weekly for 12 weeks -\\> Epirubicin + Cyclophosphamide;\n\n  * Taxol could be replaced by Taxotere\n\nAdjuvant Chemotheraphy\n\n* Epirubicin + Cyclophosphamide, 4 cycles, every 21 days -\\> Taxol weekly for 12 weeks\n* Epirubicin + Cyclophosphamide, 4 cycles, every 14 days -\\> Taxol, 4 cycles every 14 days\n* Epirubicin + Cyclophosphamide, 4 cycles every 21 days -\\> Taxol weekly + Trastuzumab with or without Pertuzumab for 1 year\n* Taxotere + Cyclophosphamide, 4 cycles, every 21 days.\n\nThese lists are not to be considered exclusive\n\nExclusion Criteria:\n\n1. Women who are pregnant or breast-feeding.\n2. Neoplastic disease other than primary breast cancer.\n3. Had major surgery other than breast cancer surgery (central venous access placement and tumor biopsies are not considered major surgery) within 4 weeks prior to randomization. Patients must be well recovered from acute effects of surgery prior to screening. Patients should not have plans to undergo major surgical procedures during the treatment period.\n4. Patients with known or symptomatic metastases.\n5. Patients unable to readily swallow. Patients with severe gastrointestinal disease (including esophagitis, gastritis, malabsorption, or obstructive symptoms) or intractable or frequent vomiting are excluded.\n6. Patients with known or suspected allergy or hypersensitivity to the study products or any of their excipients.\n7. Patients with an active, uncontrolled infection.\n8. Patients with uncontrolled diabetes mellitus.\n9. Patients with untreated clinically relevant hypothyroidism.\n10. Patients with concomitant not-correctable alterations, present before chemotherapy, possible determinants of fatigue (NRS ≥ 4), such as anemia, not well controlled pain (NRS \\> 4), insomnia, electrolyte imbalance, dehydration, anorexia\u002Fcachexia, hepatic, renal or heart failure, adrenocortical failure, neurological deficit.\n11. Other clinical diagnosis, serious chronic diseases (renal failure with creatinine clearance \\\u003C30 ml \u002F min; liver failure, heart failure with NYHA -New York Heart Association- class\\> 2), ongoing or intercurrent illness that in the Investigator's opinion would prevent the patient's participation.\n12. Patients receiving opioids or corticosteroids (except as replacement therapy at physiological dose, in subjects with adrenal insufficiency or to prevent emesis on the chemotherapy day).\n13. Patients receiving parenteral nutrition (either total or partial).\n14. Use of other investigational drug(s) within 30 days before study entry or during the study.\n15. Triple negative patients in neoadjuvant treatment with Pembrolizumab.",{"count":109,"type":22},92,[25],"The goal of this clinical trial is to test the effect of the administration of APPORTAL® in addition to the SoC (recommended physical exercise), in patients with breast cancer, suffering from fatigue during neoadjuvant and adjuvant chemotherapy. The main questions it aims to answer are:\n\n* if the food supplement APPORTAL® can be of help in supporting the physiological energy level, against the fatigue symptom in cancer patients undergoing adjuvant chemotherapy;\n* if the supplementation with APPORTAL® can optimize the nutritional status, the muscular strength, the quality of life of the patient.\n\nAlso, the patients' satisfaction on the product received, the adherence to treatment will be evaluated and the overall safety and tolerability of the study product.\n\nThe patients will be asked to perform 3 study visits from baseline to the end of treatment (at 4 and 8 weeks after baseline) and a follow-up visit after 12 weeks from baseline.\n\nThe main assessments at each visit will be:\n\n* physical examination, weight, Body Mass Index (BMI), body temperature (°C), heart rate, respiratory frequency, and systolic and diastolic blood pressure;\n* previous and concomitant treatments;\n* fatigue assessment through BFI questionnaire;\n* quality of life through questionnaire SF-12;\n* muscular strength (dynamometer)\n* Adverse Event check (from Visit 2) Moreover, at visit 1 (baseline) and at visit 3 (end of treatment) a blood sample will be collected to evaluate the blood metabolites.\n\nTelephonic follow-up will be done at 2 weeks, 6 weeks, 10 weeks to assess compliance and to recommendations on physical activity and to study treatment (only at 2 and 6 weeks) and tolerability\u002Fsafety.\n\nParticipants will receive the nutrition supplement or the placebo, in addition to the SoC (recommended physical exercise), for 8 weeks.\n\nResearchers will compare Apportal® and Placebo groups to see if the physiological energy level against the fatigue symptom, the nutritional status, the muscular strength, the quality of life of the patient improve after 8 weeks of treatment with APPORTAL® in addition to SoC (recommended physical exercise).",[113,114],"Fatigue","Breast Cancer","2025-09-26",{"date":96,"type":39},{"date":118,"type":39},"2023-11-27",{"date":120,"type":22},"2025-12-31",{"name":45,"class":46},5,""]