Telogen EffluviumNCT07484061
Efficacy and Safety of a Drinkable Nutraceutical for Hair Loss in Patients Using GLP-1/GIP Receptor Agonists
A study testing 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. in people with Telogen Effluvium, run by Olistic Research Labs S.L. at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- Telogen Effluvium
- What is being tested?
- 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.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 16 Mar 2026to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Grupo Dermatologico Y Estetico Pedro Jaen S.A.
Madrid, Madrid, 28006
Leyre Malet, PhD, +34 617862464, info@icmrresearch.com
About this study
Official title: 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.
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.
- Conditions
- Telogen Effluvium
- Being tested
- 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., Placebo control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Placebo controlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Product Arm | Experimental | Not described Receives: Dietary Supplement: 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. |
| Placebo Arm | Placebo comparator | Not described Receives: Other: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From baseline to Day 180.
Secondary outcomes (32)
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.
Measured: From baseline to Day 180.
Body composition
Body weight (Kg). Using bioelectrical impedance analysis (BIA) with the Tanita MC-780MA body composition monitor
Measured: From baseline to Day 180.
Body composition
BMI (Kg/m2). Using bioelectrical impedance analysis (BIA) with the Tanita MC-780MA body composition monitor
Measured: 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
Measured: From baseline to Day 180.
Serum iron level
Serum iron concentration measured in blood samples using standard clinical laboratory methods.
Measured: From baseline to Day 180.
Ferritin level
Serum ferritin concentration measured in blood samples using standard clinical laboratory methods.
Measured: From baseline to Day 180.
Transferrin level
Serum transferrin concentration measured in blood samples using standard clinical laboratory methods.
Measured: From baseline to Day 180.
Transferrin saturation
Transferrin saturation percentage calculated from iron metabolism parameters obtained from blood samples.
Measured: From baseline to Day 180.
Serum zinc level
Serum zinc concentration measured in blood samples using standard clinical laboratory methods.
Measured: From baseline to Day 180.
25-hydroxyvitamin D level
Serum 25-hydroxyvitamin D concentration measured in blood samples using standard clinical laboratory methods.
Measured: From baseline to Day 180.
Serum folate level
Serum folate concentration measured in blood samples using standard clinical laboratory methods.
Measured: From baseline to Day 180.
Vitamin B12 level
Serum vitamin B12 concentration measured in blood samples using standard clinical laboratory methods.
Measured: From baseline to Day 180.
Serum albumin level
Serum albumin concentration measured in blood samples using standard clinical laboratory methods.
Measured: From baseline to Day 180.
Thyroid-stimulating hormone (TSH) level
Serum thyroid-stimulating hormone concentration measured in blood samples using standard clinical laboratory methods.
Measured: From baseline to Day 180.
Free thyroxine (free T4) level
Serum free thyroxine concentration measured in blood samples using standard clinical laboratory methods.
Measured: From baseline to Day 180.
Total testosterone level
Serum total testosterone concentration measured in blood samples using standard clinical laboratory methods.
Measured: From baseline to Day 180.
Free testosterone level
Serum free testosterone concentration measured in blood samples using standard clinical laboratory methods.
Measured: From baseline to Day 180.
Dehydroepiandrosterone sulfate (DHEA-S) level
Serum dehydroepiandrosterone sulfate concentration measured in blood samples using standard clinical laboratory methods.
Measured: 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.
Measured: From baseline to Day 180.
Fasting glucose level
Fasting blood glucose concentration measured in blood samples using standard clinical laboratory methods.
Measured: From baseline to Day 180.
Glycated hemoglobin (HbA1c)
Glycated hemoglobin measured in blood samples using standard clinical laboratory methods.
Measured: From baseline to Day 180.
Fasting insulin level
Fasting serum insulin concentration measured in blood samples using standard clinical laboratory methods.
Measured: From baseline to Day 180.
HOMA-IR
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) calculated from fasting glucose and fasting insulin values.
Measured: From baseline to Day 180.
Total cholesterol level
Total cholesterol concentration measured in blood samples using standard clinical laboratory methods.
Measured: From baseline to Day 180.
HDL cholesterol level
HDL cholesterol concentration measured in blood samples using standard clinical laboratory methods.
Measured: From baseline to Day 180.
LDL cholesterol level
LDL cholesterol concentration measured in blood samples using standard clinical laboratory methods.
Measured: From baseline to Day 180.
Triglyceride level
Serum triglyceride concentration measured in blood samples using standard clinical laboratory methods.
Measured: From baseline to Day 180.
Aspartate aminotransferase (AST) level
AST concentration measured in blood samples using standard clinical laboratory methods.
Measured: From baseline to Day 180.
Alanine aminotransferase (ALT) level
ALT concentration measured in blood samples using standard clinical laboratory methods.
Measured: From baseline to Day 180.
Gamma-glutamyl transferase (GGT) level
GGT concentration measured in blood samples using standard clinical laboratory methods.
Measured: From baseline to Day 180.
Blood urea level
Blood urea concentration measured in blood samples using standard clinical laboratory methods.
Measured: From baseline to Day 180.
Serum creatinine level
Serum creatinine concentration measured in blood samples using standard clinical laboratory methods.
Measured: From baseline to Day 180.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start16 Mar 2026
- Primary completion31 May 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Telogen EffluviumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olistic Research Labs S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Grupo Dermatologico Y Estetico Pedro Jaen S.A.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07484061
- Sponsor's protocol ID
- CT-ON-04
- Status last verified
- Oct 2026
- First submitted
- 9 Mar 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29167734
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07484061
- Acronym / sponsor ID
- CT-ON-04
- Conditions
- Telogen Effluvium
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Olistic Research Labs S.L.Industry (pharma, biotech, devices)
- Collaborators
- Grupo Dermatologico Y Estetico Pedro Jaen S.A.
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Product Arm | Experimental | Dietary Supplement: 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. |
| Placebo Arm | Placebo comparator | Other: Placebo control |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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.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. | Dietary supplement | Active Product Arm |
| Placebo controlDrinkable 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. | Other | Placebo Arm |
Primary outcome
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
32 secondary outcomes
Hair loss
Time frame: From baseline to Day 180.
Body composition
Time frame: From baseline to Day 180.
Body composition
Time frame: From baseline to Day 180.
Body composition
Time frame: From baseline to Day 180.
Serum iron level
Time frame: From baseline to Day 180.
Ferritin level
Time frame: From baseline to Day 180.
Transferrin level
Time frame: From baseline to Day 180.
Transferrin saturation
Time frame: From baseline to Day 180.
Serum zinc level
Time frame: From baseline to Day 180.
25-hydroxyvitamin D level
Time frame: From baseline to Day 180.
Serum folate level
Time frame: From baseline to Day 180.
Vitamin B12 level
Time frame: From baseline to Day 180.
Serum albumin level
Time frame: From baseline to Day 180.
Thyroid-stimulating hormone (TSH) level
Time frame: From baseline to Day 180.
Free thyroxine (free T4) level
Time frame: From baseline to Day 180.
Total testosterone level
Time frame: From baseline to Day 180.
Free testosterone level
Time frame: From baseline to Day 180.
Dehydroepiandrosterone sulfate (DHEA-S) level
Time frame: From baseline to Day 180.
Sex hormone-binding globulin (SHBG) level
Time frame: From baseline to Day 180.
Fasting glucose level
Time frame: From baseline to Day 180.
Glycated hemoglobin (HbA1c)
Time frame: From baseline to Day 180.
Fasting insulin level
Time frame: From baseline to Day 180.
HOMA-IR
Time frame: From baseline to Day 180.
Total cholesterol level
Time frame: From baseline to Day 180.
HDL cholesterol level
Time frame: From baseline to Day 180.
LDL cholesterol level
Time frame: From baseline to Day 180.
Triglyceride level
Time frame: From baseline to Day 180.
Aspartate aminotransferase (AST) level
Time frame: From baseline to Day 180.
Alanine aminotransferase (ALT) level
Time frame: From baseline to Day 180.
Gamma-glutamyl transferase (GGT) level
Time frame: From baseline to Day 180.
Blood urea level
Time frame: From baseline to Day 180.
Serum creatinine level
Time frame: From baseline to Day 180.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Background: PubMed 29167734Perera 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.
- Individual participant dataSharing planned: No
Related trials for Telogen Effluvium
Not yet recruitingObservational study
Gut Microbiota and Trichoscopic Changes in Women With Telogen Effluvium on a Multifactorial Drinkable Nutraceutical: A Retrospective Observational Study
Gut Dysbiosis, Telogen Effluvium
Not yet recruitingPhase 2/3
Clinical Study of DA-001 as a Treatment for Hair Shedding Reduction and Hair Re-Growth
Telogen Effluvium, Female Pattern Hair Loss
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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. in people with Telogen Effluvium, run by Olistic Research Labs S.L. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hair loss (time frame: From baseline to Day 180.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07484061, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.