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Clinical Trials/NCT07484061
NCT07484061RecruitingNot Applicable

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 site in 1 country40 target enrollmentStarted: March 16, 2026Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
Hair loss
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
35 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Placebo Arm

Placebo Comparator

Intervention: Placebo control (Other)

Active Product Arm

Experimental

Intervention: 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)

Outcomes

Primary Outcomes

Hair loss

Time Frame: 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

Secondary Outcomes

  • 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.)

Investigators

Sponsor
Olistic Research Labs S.L.
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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