Impact of Funcional Exercise and Supplementation in Perimenopausal Women's Health
NCT07251296, Not applicable, Recruiting, University of Valencia
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Impact of Funcional Exercise and Supplementation in Perimenopausal Women's Health | ClinicalTrials.gov |
| NCT number | NCT07251296 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 90 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University of Valencia | ClinicalTrials.gov |
| Conditions | Perimenopause, Aging | ClinicalTrials.gov |
| Interventions | Exercise + nutritional supplement, Exercise + placebo supplement | ClinicalTrials.gov |
| First posted | 2025-11-26 | ClinicalTrials.gov |
| Last updated | 2025-12-22 | ClinicalTrials.gov |
Registered outcomes 22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Changes in Brain-Derived Neurotrophic Factor (BDNF) | Before and after the intervention of 10 weeks | Serum BDNF levels will be collected through a blood sample (ELISA KIT) in the morning in a fasted state to assess neuroplasticity and cognition. | ClinicalTrials.gov |
| Primary | Changes in cortisol | Before and after the intervention of 10 weeks | Serum cortisol levels will be collected through a blood sample (ELISA KIT) in the morning in a fasted state to assess hypothalamic-pituitary-adrenal (HPA) axis-mediated physiological stress. | ClinicalTrials.gov |
| Primary | Changes in inteleukin 6 (IL-6) | Before and after the intervention of 10 weeks | Serum IL-6 levels will be collected through a blood sample (ELISA KIT) in the morning in a fasted state to assess systemic inflammation and immunity | ClinicalTrials.gov |
| Primary | Changes in tumor necrosis factor alfa (TNF-α) | Before and after the intervention of 10 weeks | Serum TNF-α levels will be collected through a blood sample (ELISA KIT) in the morning in a fasted state to assess chronic inflammation and immune state, which is related with fatigue and depression. | ClinicalTrials.gov |
| Primary | Changes in Gamma-aminobutyric acid (GABA) | Before and after the intervention of 10 weeks | Serum GABA levels will be collected through a blood sample (ELISA KIT) in the morning in a fasted state to assess the state of the central nervous system, related with relaxation, anxiety and sleep conditions. | ClinicalTrials.gov |
| Primary | Changes in serotonin | Before and after the intervention of 10 weeks | Serum serotonin levels will be collected through a blood sample (ELISA KIT) in the morning in a fasted state as a key neurotransmitter involved in mood regulation, sleep, and cognition. | ClinicalTrials.gov |
| Secondary | Changes in sleep quality | Before and after the intervention of 10 weeks | Sleep quality will be assessed through the Pittsburgh Sleep Quality Index (PSQI) | ClinicalTrials.gov |
| Secondary | Changes in perceived insomnia | Before and after the intervention of 10 weeks | Perceived insomnia will be assessed through the Insomnia Severity Index (ISI) | ClinicalTrials.gov |
| Secondary | Changes in daytime sleepiness | Before and after the intervention of 10 weeks | Daytime sleepiness will be assessed through the Epworth Sleepiness Scale (ESS) | ClinicalTrials.gov |
| Secondary | Changes in state-trait anxiety | Before and after the intervention of 10 weeks | State-trait anxiety will be assessed through the State-Trait Anxiety Inventory (STAI-R) | ClinicalTrials.gov |
| Secondary | Change in depression | Before and after the intervention of 10 weeks | Depression will be assessed through the Beck Depression Inventory-II (BDI-II) | ClinicalTrials.gov |
| Secondary | Changes in general well-being | Before and after the intervention of 10 weeks | General well-being will be assessed through the WHO-5 Well-Being Index | ClinicalTrials.gov |
| Secondary | Changes in menopausal symptoms | Before and after the intervention of 10 weeks | Menopausal symptoms will be assessed through the Menopause Rating Scale (MRS) | ClinicalTrials.gov |
| Secondary | Changes in global cognitive performance | Before and after the intervention of 10 weeks | Global cognitive performance will be assessed through the Montreal Cognitive Assessment (MoCA) | ClinicalTrials.gov |
| Secondary | Changes in working memory | Before and after the intervention of 10 weeks | Working memory will be assessed through the Digit Span (WAIS-IV Digit Span subtest - forward and backward) | ClinicalTrials.gov |
| Secondary | Changes in selective attention | Before and after the intervention of 10 weeks | Selective attention will be assessed through the Stroop Test (short version) | ClinicalTrials.gov |
| Secondary | Changes in processing speed and cognitive flexibility | Before and after the intervention of 10 weeks | Processing speed and cognitive flexibility will be assessed through the Trail Making Test A and B (TMT-A/B) | ClinicalTrials.gov |
| Secondary | Changes in gait speed/aerobic capacity | Before and after the intervention of 10 weeks | Gait speed/aerobic capacity will be assessed through the 6-m Walk Test | ClinicalTrials.gov |
| Secondary | Changes in lower limb strength | Before and after the intervention of 10 weeks | Lower limb strength will be assessed through the 30-s Chair Stand Test | ClinicalTrials.gov |
| Secondary | Changes in handgrip strength | Before and after the intervention of 10 weeks | Handgrip strength will be assessed through the Handgrip dynamometry (Jamar Hand Dynamometer). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Digit Span Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)