Drinkable nutraceutical to reduce hair loss in women starting GLP‑1/GIP treatment
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.
This study will test whether a daily drinkable nutraceutical reduces hair shedding in women over 35 who have recently started GLP‑1/GIP receptor agonist therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 35 Years and up |
| Sex | Female |
| Sponsor | Olistic Research Labs S.L. Industry-sponsored |
| Locations | 1 site (Madrid, Madrid) |
| Trial ID | NCT07484061 on ClinicalTrials.gov |
What this trial studies
This is a 6-month, randomized, placebo-controlled trial testing daily supplementation with Olistic© Next Women versus placebo in women who recently began GLP‑1/GIP agonist treatment. The study measures changes in hair loss and monitors safety and tolerability throughout the treatment period. Eligible participants are women over 35 who initiated GLP‑1/GIP therapy within the prior three months and do not have scarring scalp disease or systemic causes of alopecia. The trial is sponsored by Olistic Research Labs S.L. and conducted at a dermatology clinic in Madrid, Spain.
Who should consider this trial
Good fit: Women older than 35 who started GLP‑1/GIP agonist therapy within the past three months and are experiencing or at risk for increased hair shedding, without scarring scalp disease or identified systemic causes of alopecia.
Not a fit: Women with scarring or autoimmune alopecia, hair loss due to thyroid disease, anemia, lupus or other medical causes, those allergic to the supplement ingredients, or those unable to attend clinic visits are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the supplement could provide an easy, daily option to reduce GLP‑1/GIP–related hair shedding and improve hair quality.
How similar studies have performed: Some small trials of oral multinutrient or nutraceutical combinations have shown modest benefits for telogen effluvium, but this specific drinkable formula and its use in patients on GLP‑1/GIP agonists is novel and unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Madrid, Madrid
- Grupo Dermatologico Y Estetico Pedro Jaen S.A. — Madrid, Madrid, Spain (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.