NCT07484061招募中不适用
Evaluation of the Efficacy and Safety of a Drinkable Nutraceutical in Improving Hair Loss in Patients Treated With GLP-1/GIP Receptor Agonists: a Double-blind, 1:1 Randomized, Placebo-controlled Study.
Olistic Research Labs S.L.1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年3月16日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Hair loss
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female gender.
- •Age >35 years.
- •Initiation of treatment with a GLP-1/GIP agonist, or treatment duration < 3 months, as per routine clinical practice in the endocrinology clinic.
- •Having signed the participant information sheet and the written informed consent and having been informed of the objective of the study.
- •Additional criteria to be included by the client.
排除标准
- •Allergy or hypersensitivity to any of the components of the product, or to a product from a similar category to the one being tested.
- •Scalp diseases: cicatricial alopecia, alopecia areata, folliculitis decalvans, psoriasis, moderate to severe seborrheic dermatitis, eczema, cancer, etc.
- •Women presenting alopecia due to an underlying medical condition (hypothyroidism, anemia, lupus, etc.).
- •Pharmacological treatment that may promote the onset of telogen effluvium, initiated within the 3 months prior to study start (e.g., valproic acid, carbamazepine, phenytoin, selective serotonin reuptake inhibitors, oral anticoagulants, retinoids, beta-blockers). Patients who have undergone a dose change of these medications within the same period are also excluded.
- •Women with uncontrolled thyroid disorders (hyperthyroidism or hypothyroidism) within the 6 months prior to study initiation.
- •Women who have used anti-hair loss products within the last 3 months.
- •Women who have initiated or undergone dermatological treatment for hair loss within the last 6 months (minoxidil, finasteride, PRP, mesotherapy, etc.).
- •Women who have undergone hair transplantation within the 18 months prior to study initiation.
- •Women who have initiated treatment with anxiolytics, antidepressants, amphetamines, ACE inhibitors, or iron within the last 3 months.
- •Women who initiated or discontinued hormonal treatment (oral contraceptives, oral or topical hormone replacement therapy, ovarian stimulation) within the 3 months prior to study initiation.
- •Pregnant women, postpartum women (within 6 months), breastfeeding women, or women planning to become pregnant during the study period.
- •Additional exclusion criteria to be specified by the sponsor.
- •Any condition that, in the investigator's opinion, makes participation in the study inappropriate.
研究组 & 干预措施
Placebo Arm
Placebo Comparator
干预措施: Placebo control (Other)
Active Product Arm
Experimental
干预措施: 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)
结局指标
主要结局
Hair loss
时间窗: From baseline to Day 180.
• 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
次要结局
- Body composition(From baseline to Day 180.)
- Hair loss(From baseline to Day 180.)
- Serum iron level(From baseline to Day 180.)
- Ferritin level(From baseline to Day 180.)
- Transferrin level(From baseline to Day 180.)
- Transferrin saturation(From baseline to Day 180.)
- Serum zinc level(From baseline to Day 180.)
- 25-hydroxyvitamin D level(From baseline to Day 180.)
- Serum folate level(From baseline to Day 180.)
- Vitamin B12 level(From baseline to Day 180.)
- Serum albumin level(From baseline to Day 180.)
- Thyroid-stimulating hormone (TSH) level(From baseline to Day 180.)
- Free thyroxine (free T4) level(From baseline to Day 180.)
- Total testosterone level(From baseline to Day 180.)
- Free testosterone level(From baseline to Day 180.)
- Dehydroepiandrosterone sulfate (DHEA-S) level(From baseline to Day 180.)
- Sex hormone-binding globulin (SHBG) level(From baseline to Day 180.)
- Fasting glucose level(From baseline to Day 180.)
- Glycated hemoglobin (HbA1c)(From baseline to Day 180.)
- Fasting insulin level(From baseline to Day 180.)
- HOMA-IR(From baseline to Day 180.)
- Total cholesterol level(From baseline to Day 180.)
- HDL cholesterol level(From baseline to Day 180.)
- LDL cholesterol level(From baseline to Day 180.)
- Triglyceride level(From baseline to Day 180.)
- Aspartate aminotransferase (AST) level(From baseline to Day 180.)
- Alanine aminotransferase (ALT) level(From baseline to Day 180.)
- Gamma-glutamyl transferase (GGT) level(From baseline to Day 180.)
- Blood urea level(From baseline to Day 180.)
- Serum creatinine level(From baseline to Day 180.)
研究者
研究点 (1)
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