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| Name | Class |
|---|---|
| Grupo Dermatologico Y Estetico Pedro Jaen S.A. | UNKNOWN |
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The purpose of this clinical trial is to evaluate the efficacy of Olistic© Next Women, a nutraceutical supplement, compared with placebo in improving hair loss in patients undergoing treatment with GLP-1/GIP agonists. This 6-month, randomized, placebo-controlled clinical study investigates whether daily supplementation with Olistic© Next Women leads to significant improvements in hair loss in this patient population. In addition, the study assesses the safety and tolerability of the product throughout the treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Product Arm | Experimental |
| |
| Placebo Arm | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drinkable multifactorial food supplement containing vitamins, minerals, amino acids, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women +45. | Dietary Supplement | Drinkable multifactorial food supplement in liquid form, administered once daily in a 25 mL single-dose vial, for a duration of 180 days. The formulation contains a combination of vitamins, minerals, amino acids, plant extracts, and other bioactive compounds designed to support hair growth and scalp health in women +45. |
| Measure | Description | Time Frame |
|---|---|---|
| Hair loss | • Patient Reported Outcome using the Hair Shedding Scale: will assess the degree of hair loss among participants. On the day of the visit, they will be shown an A4 sheet with six ranges: between 1 (minimal shedding) to 6 (copious hair shedding). Ref. Perera E and Sinclair R, 2017 | From baseline to Day 180. |
| Measure | Description | Time Frame |
|---|---|---|
| Hair loss | Comb and Wash Test: this test will quantify the number of fallen hairs (outcome number of shed hairs). It will be carried out after refraining from washing the hair for 48 hours and combing the hair for 24 hours. | From baseline to Day 180. |
| Body composition |
| Measure | Description | Time Frame |
|---|---|---|
| Self-assessment questionnaire | Subject-reported perception of hair condition assessed using a 12-item questionnaire covering perceived hair density, hair shedding, hair strength, hair volume, appearance, and scalp condition. Each item is rated on a 5-point Likert scale ranging from "strongly disagree" to "strongly agree." Higher scores indicate greater perceived improvement in hair and scalp condition. | From baseline to Day 180. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grupo Dermatologico Y Estetico Pedro Jaen S.A. | Recruiting | Madrid | Madrid | 28006 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29167734 | Background | Perera E, Sinclair R. Treatment of chronic telogen effluvium with oral minoxidil: A retrospective study. F1000Res. 2017 Sep 6;6:1650. doi: 10.12688/f1000research.11775.1. eCollection 2017. |
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|
| Placebo control | Other | Drinkable formulation consisting of an excipient formulation designed to mimic the organoleptic properties of the active product, reproducing its color and texture while achieving a highly similar taste profile. |
|
Body weight (Kg). Using bioelectrical impedance analysis (BIA) with the Tanita MC-780MA body composition monitor |
| From baseline to Day 180. |
| Body composition | BMI (Kg/m2). Using bioelectrical impedance analysis (BIA) with the Tanita MC-780MA body composition monitor | From baseline to Day 180. |
| Body composition | Fat mass and fat-free mass percentages. Using bioelectrical impedance analysis (BIA) with the Tanita MC-780MA body composition monitor | From baseline to Day 180. |
| Serum iron level | Serum iron concentration measured in blood samples using standard clinical laboratory methods. | From baseline to Day 180. |
| Ferritin level | Serum ferritin concentration measured in blood samples using standard clinical laboratory methods. | From baseline to Day 180. |
| Transferrin level | Serum transferrin concentration measured in blood samples using standard clinical laboratory methods. | From baseline to Day 180. |
| Transferrin saturation | Transferrin saturation percentage calculated from iron metabolism parameters obtained from blood samples. | From baseline to Day 180. |
| Serum zinc level | Serum zinc concentration measured in blood samples using standard clinical laboratory methods. | From baseline to Day 180. |
| 25-hydroxyvitamin D level | Serum 25-hydroxyvitamin D concentration measured in blood samples using standard clinical laboratory methods. | From baseline to Day 180. |
| Serum folate level | Serum folate concentration measured in blood samples using standard clinical laboratory methods. | From baseline to Day 180. |
| Vitamin B12 level | Serum vitamin B12 concentration measured in blood samples using standard clinical laboratory methods. | From baseline to Day 180. |
| Serum albumin level | Serum albumin concentration measured in blood samples using standard clinical laboratory methods. | From baseline to Day 180. |
| Thyroid-stimulating hormone (TSH) level | Serum thyroid-stimulating hormone concentration measured in blood samples using standard clinical laboratory methods. | From baseline to Day 180. |
| Free thyroxine (free T4) level | Serum free thyroxine concentration measured in blood samples using standard clinical laboratory methods. | From baseline to Day 180. |
| Total testosterone level | Serum total testosterone concentration measured in blood samples using standard clinical laboratory methods. | From baseline to Day 180. |
| Free testosterone level | Serum free testosterone concentration measured in blood samples using standard clinical laboratory methods. | From baseline to Day 180. |
| Dehydroepiandrosterone sulfate (DHEA-S) level | Serum dehydroepiandrosterone sulfate concentration measured in blood samples using standard clinical laboratory methods. | From baseline to Day 180. |
| Sex hormone-binding globulin (SHBG) level | Serum sex hormone-binding globulin concentration measured in blood samples using standard clinical laboratory methods. | From baseline to Day 180. |
| Fasting glucose level | Fasting blood glucose concentration measured in blood samples using standard clinical laboratory methods. | From baseline to Day 180. |
| Glycated hemoglobin (HbA1c) | Glycated hemoglobin measured in blood samples using standard clinical laboratory methods. | From baseline to Day 180. |
| Fasting insulin level | Fasting serum insulin concentration measured in blood samples using standard clinical laboratory methods. | From baseline to Day 180. |
| HOMA-IR | Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) calculated from fasting glucose and fasting insulin values. | From baseline to Day 180. |
| Total cholesterol level | Total cholesterol concentration measured in blood samples using standard clinical laboratory methods. | From baseline to Day 180. |
| HDL cholesterol level | HDL cholesterol concentration measured in blood samples using standard clinical laboratory methods. | From baseline to Day 180. |
| LDL cholesterol level | LDL cholesterol concentration measured in blood samples using standard clinical laboratory methods. | From baseline to Day 180. |
| Triglyceride level | Serum triglyceride concentration measured in blood samples using standard clinical laboratory methods. | From baseline to Day 180. |
| Aspartate aminotransferase (AST) level | AST concentration measured in blood samples using standard clinical laboratory methods. | From baseline to Day 180. |
| Alanine aminotransferase (ALT) level | ALT concentration measured in blood samples using standard clinical laboratory methods. | From baseline to Day 180. |
| Gamma-glutamyl transferase (GGT) level | GGT concentration measured in blood samples using standard clinical laboratory methods. | From baseline to Day 180. |
| Blood urea level | Blood urea concentration measured in blood samples using standard clinical laboratory methods. | From baseline to Day 180. |
| Serum creatinine level | Serum creatinine concentration measured in blood samples using standard clinical laboratory methods. | From baseline to Day 180. |
| Food consumption frequency questionnaire (PREDIMED questionnaire) | Adherence to the Mediterranean diet assessed using the validated 14-item PREDIMED (Prevención con Dieta Mediterránea) questionnaire. The questionnaire evaluates the frequency of consumption of key food groups and dietary habits characteristic of the Mediterranean diet, including olive oil use, fruit and vegetable intake, legumes, fish, nuts, red meat, sugary beverages, commercial pastries, and wine consumption. Each item is scored 0 or 1, resulting in a total score ranging from 0 to 14, with higher scores indicating greater adherence to the Mediterranean diet. | From baseline to Day 180. |
| ID | Term |
|---|---|
| D008903 | Minerals |
| D000596 | Amino Acids |
| D010936 | Plant Extracts |
| ID | Term |
|---|---|
| D007287 | Inorganic Chemicals |
| D000602 | Amino Acids, Peptides, and Proteins |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D004364 | Pharmaceutical Preparations |
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