Female Breast CancerMEXBSONCT06696378
Melatonin Supplementation and Exercise Program in Breast Cancer Women
A study testing Melatonin 6 mg in people with Female Breast Cancer and Older Adults, run by University of Valladolid at 1 site in Spain.
Trial summary
Introduction: Breast cancer (BC) remains the leading cause of cancer in women with nearly 1.4 million new cases worldwide annually and 27.000 in Spain. Increasingly effective oncology therapies, however, have numerous adverse effects such as muscle degeneration, fatigue, decreased physical function and aerobic… Read more about this study
- Who is it for?
- Ages 60 to 75 years, women only
- Conditions the study is for
- Female Breast Cancer, Older Adults, Exercise Trainning Progrmam
- What is being tested?
- Melatonin 6 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteSpain
- Study dates
- 11 Nov 2024to 5 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women aged 60-75 years with a history of ductal carcinoma in situ, lobular carcinoma in situ, or stage I-III breast cancer diagnosed 5 years or more previously; not currently receiving chemotherapy, radiotherapy, or endocrine therapy; and with an Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
Who cannot join
- Women who had exercised regularly for at least 20 minutes per session and at least twice per week during the 3 months before the study; stage IV breast cancer or systemic recurrence; previous malignancies of any type other than breast cancer, basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix; known autoimmune diseases, including systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and multiple sclerosis; decompensated liver cirrhosis; severe kidney disease; use of adjuvant hormonal therapy, oral estrogen or progesterone replacement therapy, or luteinizing hormone-releasing hormone agonists currently or within the previous 60 days; less than 6 months since completion of chemotherapy; concomitant use of sleeping pills every night at bedtime; concomitant use of black cohosh, flaxseed, or soy in pill or supplement form; functional limitation defined as a Barthel Index <100 or Lawton-Brody score <8; uncontrolled hypertension (>180/100 mmHg); uncontrolled atrial or ventricular arrhythmias, dissecting aortic aneurysm, severe aortic stenosis, or acute endocarditis/pericarditis; acute thromboembolic disease; moderate or severe chronic obstructive pulmonary disease (COPD) with BODE index C or D; recent bone fracture within the previous month; any other medical condition considered by the treating physician to preclude participation in physical activity; neoadjuvant chemotherapy or radiotherapy; concomitant use of beta-blockers; less than 6 months since completion of radiotherapy; concomitant use of postmenopausal hormone replacement therapy; use of any type of oral melatonin supplement within the previous 30 days; acute or chronic heart failure with New York Heart Association (NYHA) class >II; uncontrolled orthostatic hypotension; recent acute myocardial infarction (3-6 months) or unstable angina; acute or chronic respiratory failure; diabetes mellitus with acute decompensation or uncontrolled hypoglycemia; history of diagnosed dementia; and shift work or night work.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Faculty of Health Sciences, University of Valladolid Soria Campus
Soria, 42004
About this study
Official title: Impact of Melatonin Supplementation Plus Exercise Program in Women Who Have Suffered From Breast Cancer in the Province of Soria, Spain
Introduction: Breast cancer (BC) remains the leading cause of cancer in women with nearly 1.4 million new cases worldwide annually and 27.000 in Spain. Increasingly effective oncology therapies, however, have numerous adverse effects such as muscle degeneration, fatigue, decreased physical function and aerobic capacity, and deteriorating quality of life. In this sense, physical activity (PA) seems to be an interesting non-pharmacological strategy to alleviate these serious complications and with potential benefits for women with BC. Melatonin (N-acetyl-5 methoxytryptamine) is an indolic compound present with pleiotropic bioactions that regulates the circadian rhythm, antioxidant, anti-inflammatory, immunostimulant, cardioprotective, antidiabetic, antiobesity, neuroprotective, and antiaging actions. Furthermore, in recent years, many studies have described the key role of melatonin in preventing and developing cancer. The general anticarcinogenic mechanisms include epigenetic control, cell proliferation modulation, cell cycle regulation, apoptosis induction, and telomerase inhibition. Melatonin also exerts antiestrogenic activity, which is particularly significant in hormone-dependent tumors, regulating the expression and transactivation of the estrogen receptor, and modulating the enzymes involved in the local synthesis of estrogens. Despite all the mentioned properties, the use of melatonin in daily clinical practice is very limited, and additional studies are needed to better establish the role of this hormone in oncological clinical applications against different types of cancer.
Objective: To analyze the effect of supplementation with 4 g/day of melatonin for 10 weeks on muscle damage (CK and LDH), hormonal responses (estradiol, testosterone, cortisol and testosterone/cortisol ratio), antioxidant capacity (BAP and d-ROMs), Exerkins (Irisin and Sestrin 2), physical performance (handgrip strength, RPE and SPPB), anthropometry (body mass, BMI and fat mass) and WHOQOL-BREF (physical and psychological health, social relationships and environment) in women over 60 years of age who have suffered breast cancer and who follow a physical training program.
Methods: A total of 20 female volunteers between 60 and 73 years old (age: 65.5±4.52 years, BMI: 25.83±2.67 and body fat percentage: 33.73±5.54) who followed a physical activity adapted to their age and abilities are the members. of this study. The volunteers were divided into two groups: placebo (CG; n = 10) and supplemented with 5 g/day of melatonin (GI; n = 10). Differtent test were performed muscle damage (CK, and LDH), hormonal responses (estradiol, testosterone, cortisol, and testosterone/cortisol ratio), antioxidant capacity (BAP and d-ROMs), Exerkins (Irisin and Sestrin 2), physical performance (Hand-grip strength, RPE and SPPB), anthropometrics (Body mass, BMI and fat mass), and WHOQOL-BREF (physical and psychological health, social relationships and environment) were analyzed at the beginning (T1) and at the end of the 10 weeks of intervention (T2).
- Being tested
- Melatonin 6 mg, Placebo
- Keywords
- Brear Cancer, Melatonin, quality of life, physical performance, health biomarkers, antioxidant capacity, anthropometrics parameters, Exerkins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin 6 mgDietary supplement
One capsule containing 6 mg of melatonin was administered once daily for 10 weeks. Melatonin (Nutrifoods® Laboratories, Barcelona, Spain) was prepared by the Magistral Formulation Laboratory of a pharmacy (Soria, Spain), in accordance with the requirements of the Royal Spanish Pharmacopoeia (Ministry of Health, Government of Spain). Melatonin had a technical data sheet certifying its composition and purity (Reference No. DIE-134).
PlaceboOther
One matched placebo capsule containing 100 mg of maltodextrin was administered once daily for 10 weeks. The placebo capsule was identical in appearance to the melatonin capsule to maintain participant blinding.
| Study group | Role | What they receive |
|---|---|---|
| Melatonin supplementation group | Experimental | Participants received one capsule containing 6 mg of melatonin once daily for 10 weeks, in addition to the concurrent exercise-training program. Receives: Dietary Supplement: Melatonin 6 mg |
| Placebo supplementation group | Placebo comparator | Participants received one matched placebo capsule once daily for 10 weeks, in addition to the same concurrent exercise-training program. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma irisin concentration
Plasma irisin concentration was measured using an enzyme-linked immunosorbent assay (ELISA).
Measured: Baseline and after 10 weeks (Day 70)
Plasma sestrin-2 concentration
Plasma sestrin-2 concentration was measured using an enzyme-linked immunosorbent assay (ELISA).
Measured: Baseline and after 10 weeks (Day 70)
Secondary outcomes (13)
Biological antioxidant potential (BAP)
Biological antioxidant potential (BAP) was measured to assess plasma antioxidant capacity.
Measured: Baseline and after 10 weeks (Day 70)
Plasma reactive oxygen metabolite concentration (d-ROMs)
Plasma reactive oxygen metabolites (d-ROMs), reflecting circulating hydroperoxide levels and oxidant status, were measured using the FREE Carpe Diem analytical system.
Measured: Baseline and after 10 weeks (Day 70)
World Health Organization Quality of Life-BREF (WHOQOL-BREF) domain scores
Quality of life was assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF), covering four domains: physical health, psychological health, social relationships, and environment. Domain scores range from 4 to 20, with higher scores indicating better quality of life.
Measured: Baseline and after 10 weeks (Day 70)
Plasma creatine kinase (CK) activity
Plasma creatine kinase (CK) activity was measured as a biomarker of muscle damage using an automated clinical chemistry analyzer (Hitachi 917).
Measured: Baseline and after 10 weeks (Day 70)
Plasma lactate dehydrogenase (LDH) activity
Plasma lactate dehydrogenase (LDH) activity was measured as a biomarker of muscle damage using an automated clinical chemistry analyzer (Hitachi 917).
Measured: Baseline and after 10 weeks (Day 70)
Blood cortisol concentration
Blood cortisol concentration was measured using an enzyme-linked fluorescence assay (ELFA) on a MiniVIDAS® multiparametric immunoanalyzer. Results were expressed in µg/dL.
Measured: Baseline and after 10 weeks (Day 70)
Blood total testosterone concentration
Blood total testosterone concentration was measured using an enzyme-linked immunosorbent assay (ELISA). Results were expressed in ng/mL.
Measured: Baseline and after 10 weeks (Day 70)
Plasma estradiol concentration
Plasma estradiol concentration was measured using an enzyme-linked immunosorbent assay (ELISA).
Measured: Baseline and after 10 weeks (Day 70)
Body mass index (BMI)
Body mass index (BMI) was calculated from body mass and height and expressed in kg/m².
Measured: Baseline and after 10 weeks (Day 70)
Fat mass percentage
Fat mass was assessed by bioelectrical impedance analysis using a Tanita BC-730 analyzer and expressed as a percentage of body mass (%)
Measured: Baseline and after 10 weeks (Day 70)
Short Physical Performance Battery (SPPB) total score
Physical performance was assessed using the Short Physical Performance Battery (SPPB), comprising balance, 4-meter gait speed, and five-repetition chair-stand tests. The total score ranges from 0 to 12 points, with higher scores indicating better physical performance.
Measured: Baseline and after 10 weeks (Day 70)
Hand-grip strength
Handgrip strength was measured as an indicator of upper-limb muscular strength and expressed in kilograms (kg).
Measured: Baseline and after 10 weeks (Day 70)
Rating of Perceived Exertion using the Borg Category Ratio-10 (CR-10) scale
Perceived exertion was assessed using the Borg Category Ratio-10 (CR-10) scale, ranging from 0 (no exertion) to 10 (maximal exertion). Higher scores indicate greater perceived exertion.
Measured: Baseline and after 10 weeks (Day 70)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start11 Nov 2024
- Primary completion5 May 2025
- Study completion5 May 2025
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 Female Breast CancerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel group placebo-controlled randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valladolid
- Sponsor type
- University, hospital or other
- Collaborators
- Sanidad de Castilla y León, Ministerio de Ciencia e Innovación, Spain, Fundación General Universidad de Valladolid
- Responsible party
- Principal investigator, Diego Fernández Lázaro, University of Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06696378
- Sponsor's protocol ID
- 2024.08.12
- Acronym
- MEXBSO
- Status last verified
- Sep 2026
- First submitted
- 22 Aug 2024
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Celorrio San Miguel AM, Cacharro LM, Santamaria G, Garrosa M, Celorrio San Miguel M, Roche E, Garrosa E, Fernandez-Lazaro D. Adjuvant melatonin therapy during exercise prescription in breast cancer survivors on physical and anthropometric parameters, quality of life, and hormonal response. A randomized controlled trial. Front Sports Act Living. 2025 Jun 23;7:1594733. doi: 10.3389/fspor.2025.1594733. eCollection 2025.
PubMed 40625889
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Melatonin Supplementation Plus Exercise Program in Women Who Have Suffered From Breast Cancer in the Province of Soria, Spain
- ClinicalTrials.gov ID
- NCT06696378
- Acronym / sponsor ID
- MEXBSO / 2024.08.12
- Keywords
- Brear Cancer, Melatonin, quality of life, physical performance, health biomarkers, antioxidant capacity, anthropometrics parameters, Exerkins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of ValladolidUniversity, hospital or other
- Collaborators
- Sanidad de Castilla y León, Ministerio de Ciencia e Innovación, Spain, Fundación General Universidad de Valladolid
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 5 May 2025 (actual)
- Study completion
- 5 May 2025 (actual)
- First posted
- 20 Nov 2024 (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.
Introduction: Breast cancer (BC) remains the leading cause of cancer in women with nearly 1.4 million new cases worldwide annually and 27.000 in Spain. Increasingly effective oncology therapies, however, have numerous adverse effects such as muscle degeneration, fatigue, decreased physical function and aerobic capacity, and deteriorating quality of life. In this sense, physical activity (PA) seems to be an interesting non-pharmacological strategy to alleviate these serious complications and with potential benefits for women with BC. Melatonin (N-acetyl-5 methoxytryptamine) is an indolic compound present with pleiotropic bioactions that regulates the circadian rhythm, antioxidant, anti-inflammatory, immunostimulant, cardioprotective, antidiabetic, antiobesity, neuroprotective, and antiaging actions. Furthermore, in recent years, many studies have described the key role of melatonin in preventing and developing cancer. The general anticarcinogenic mechanisms include epigenetic control, cell proliferation modulation, cell cycle regulation, apoptosis induction, and telomerase inhibition. Melatonin also exerts antiestrogenic activity, which is particularly significant in hormone-dependent tumors, regulating the expression and transactivation of the estrogen receptor, and modulating the enzymes involved in the local synthesis of estrogens. Despite all the mentioned properties, the use of melatonin in daily clinical practice is very limited, and additional studies are needed to better establish the role of this hormone in oncological clinical applications against different types of cancer.
Objective: To analyze the effect of supplementation with 4 g/day of melatonin for 10 weeks on muscle damage (CK and LDH), hormonal responses (estradiol, testosterone, cortisol and testosterone/cortisol ratio), antioxidant capacity (BAP and d-ROMs), Exerkins (Irisin and Sestrin 2), physical performance (handgrip strength, RPE and SPPB), anthropometry (body mass, BMI and fat mass) and WHOQOL-BREF (physical and psychological health, social relationships and environment) in women over 60 years of age who have suffered breast cancer and who follow a physical training program.
Methods: A total of 20 female volunteers between 60 and 73 years old (age: 65.5±4.52 years, BMI: 25.83±2.67 and body fat percentage: 33.73±5.54) who followed a physical activity adapted to their age and abilities are the members. of this study. The volunteers were divided into two groups: placebo (CG; n = 10) and supplemented with 5 g/day of melatonin (GI; n = 10). Differtent test were performed muscle damage (CK, and LDH), hormonal responses (estradiol, testosterone, cortisol, and testosterone/cortisol ratio), antioxidant capacity (BAP and d-ROMs), Exerkins (Irisin and Sestrin 2), physical performance (Hand-grip strength, RPE and SPPB), anthropometrics (Body mass, BMI and fat mass), and WHOQOL-BREF (physical and psychological health, social relationships and environment) were analyzed at the beginning (T1) and at the end of the 10 weeks of intervention (T2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Parallel group placebo-controlled randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Melatonin supplementation group | Experimental | Dietary Supplement: Melatonin 6 mgParticipants received one capsule containing 6 mg of melatonin once daily for 10 weeks, in addition to the concurrent exercise-training program. |
| Placebo supplementation group | Placebo comparator | Other: PlaceboParticipants received one matched placebo capsule once daily for 10 weeks, in addition to the same concurrent exercise-training program. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Postmenopausal women aged 60-75 years with a history of ductal carcinoma in situ, lobular carcinoma in situ, or stage I-III breast cancer diagnosed 5 years or more previously; not currently receiving chemotherapy, radiotherapy, or endocrine therapy; and with an Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
Key exclusion criteria (1 listed)
- Women who had exercised regularly for at least 20 minutes per session and at least twice per week during the 3 months before the study; stage IV breast cancer or systemic recurrence; previous malignancies of any type other than breast cancer, basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix; known autoimmune diseases, including systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and multiple sclerosis; decompensated liver cirrhosis; severe kidney disease; use of adjuvant hormonal therapy, oral estrogen or progesterone replacement therapy, or luteinizing hormone-releasing hormone agonists currently or within the previous 60 days; less than 6 months since completion of chemotherapy; concomitant use of sleeping pills every night at bedtime; concomitant use of black cohosh, flaxseed, or soy in pill or supplement form; functional limitation defined as a Barthel Index <100 or Lawton-Brody score <8; uncontrolled hypertension (>180/100 mmHg); uncontrolled atrial or ventricular arrhythmias, dissecting aortic aneurysm, severe aortic stenosis, or acute endocarditis/pericarditis; acute thromboembolic disease; moderate or severe chronic obstructive pulmonary disease (COPD) with BODE index C or D; recent bone fracture within the previous month; any other medical condition considered by the treating physician to preclude participation in physical activity; neoadjuvant chemotherapy or radiotherapy; concomitant use of beta-blockers; less than 6 months since completion of radiotherapy; concomitant use of postmenopausal hormone replacement therapy; use of any type of oral melatonin supplement within the previous 30 days; acute or chronic heart failure with New York Heart Association (NYHA) class >II; uncontrolled orthostatic hypotension; recent acute myocardial infarction (3-6 months) or unstable angina; acute or chronic respiratory failure; diabetes mellitus with acute decompensation or uncontrolled hypoglycemia; history of diagnosed dementia; and shift work or night work.
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 |
|---|---|---|
| Melatonin 6 mgOne capsule containing 6 mg of melatonin was administered once daily for 10 weeks. Melatonin (Nutrifoods® Laboratories, Barcelona, Spain) was prepared by the Magistral Formulation Laboratory of a pharmacy (Soria, Spain), in accordance with the requirements of the Royal Spanish Pharmacopoeia (Ministry of Health, Government of Spain). Melatonin had a technical data sheet certifying its composition and purity (Reference No. DIE-134). | Dietary supplement | Melatonin supplementation group |
| PlaceboOne matched placebo capsule containing 100 mg of maltodextrin was administered once daily for 10 weeks. The placebo capsule was identical in appearance to the melatonin capsule to maintain participant blinding. | Other | Placebo supplementation group |
Primary outcome
Plasma irisin concentration
Time frame: Baseline and after 10 weeks (Day 70)
Plasma irisin concentration was measured using an enzyme-linked immunosorbent assay (ELISA).
Plasma sestrin-2 concentration
Time frame: Baseline and after 10 weeks (Day 70)
Plasma sestrin-2 concentration was measured using an enzyme-linked immunosorbent assay (ELISA).
13 secondary outcomes
Biological antioxidant potential (BAP)
Time frame: Baseline and after 10 weeks (Day 70)
Plasma reactive oxygen metabolite concentration (d-ROMs)
Time frame: Baseline and after 10 weeks (Day 70)
World Health Organization Quality of Life-BREF (WHOQOL-BREF) domain scores
Time frame: Baseline and after 10 weeks (Day 70)
Plasma creatine kinase (CK) activity
Time frame: Baseline and after 10 weeks (Day 70)
Plasma lactate dehydrogenase (LDH) activity
Time frame: Baseline and after 10 weeks (Day 70)
Blood cortisol concentration
Time frame: Baseline and after 10 weeks (Day 70)
Blood total testosterone concentration
Time frame: Baseline and after 10 weeks (Day 70)
Plasma estradiol concentration
Time frame: Baseline and after 10 weeks (Day 70)
Body mass index (BMI)
Time frame: Baseline and after 10 weeks (Day 70)
Fat mass percentage
Time frame: Baseline and after 10 weeks (Day 70)
Short Physical Performance Battery (SPPB) total score
Time frame: Baseline and after 10 weeks (Day 70)
Hand-grip strength
Time frame: Baseline and after 10 weeks (Day 70)
Rating of Perceived Exertion using the Borg Category Ratio-10 (CR-10) scale
Time frame: Baseline and after 10 weeks (Day 70)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Derived from this study: PubMed 40625889Celorrio San Miguel AM, Cacharro LM, Santamaria G, Garrosa M, Celorrio San Miguel M, Roche E, Garrosa E, Fernandez-Lazaro D. Adjuvant melatonin therapy during exercise prescription in breast cancer survivors on physical and anthropometric parameters, quality of life, and hormonal response. A randomized controlled trial. Front Sports Act Living. 2025 Jun 23;7:1594733. doi: 10.3389/fspor.2025.1594733. eCollection 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin 6 mg in people with Female Breast Cancer and Older Adults, run by University of Valladolid 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 30 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma irisin concentration (time frame: Baseline and after 10 weeks (Day 70)). The study lists 2 primary outcomes in all. 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 NCT06696378, 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 30 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.