PerimenopauseNCT07251296
Impact of Funcional Exercise and Supplementation in Perimenopausal Women's Health
A study testing Exercise + nutritional supplement in people with Perimenopause and Aging, run by University of Valencia at 1 site in Spain.
Trial summary
The goal of this clinical trial is to learn whether a natural-origin nutritional supplement, combined with a functional exercise program, can improve psycho-emotional, cognitive, functional, and neuroendocrine health in perimenopausal women. The study will also help determine the safety of this combined intervention. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Perimenopause, Aging
- What is being tested?
- Exercise + nutritional supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 15 Dec 2025to Jul 2026
- 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 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged between 45 and 65 years.
- In the menopausal transition (defined by irregular menstrual cycles and typical symptoms within the past year) or postmenopause.
- Score ≥ 8 on the Menopause Rating Scale (MRS), indicating moderate menopausal symptom intensity.
- Regular nighttime sleep and not engaged in shift work.
- Low physical activity level: less than 150 minutes per week of moderate or vigorous physical activity, as assessed by the short-form IPAQ or a similar questionnaire.
- Body mass index (BMI) between 18.5 and 35 kg/m².
- Sufficient functional and cognitive capacity to participate in supervised physical exercise and follow the study protocol.
- Signed informed consent and availability to attend all scheduled sessions and assessments.
Who cannot join
- Current or recent (within the last 3 months) use of hormone replacement therapy (HRT).
- Surgical, induced, or early menopause (before age 40).
- Current treatment with medications that may affect mood, sleep, or vasomotor symptoms, including: antidepressants (SSRIs, SNRIs, tricyclics); anxiolytics or hypnotics; phytoestrogens, isoflavones, or other over-the-counter hormonal supplements.
- Medical diagnosis of severe or uncontrolled chronic diseases, including cardiovascular, respiratory (particularly sleep apnea), metabolic, active oncological, neurological, severe autoimmune, or psychiatric disorders.
- Regular use within the past 3 months of nutritional or sports supplements that may interfere with study outcomes (e.g., creatine, protein, omega-3, adaptogens, etc.).
- Medical contraindications for moderate-to-vigorous physical exercise, as determined by the PAR-Q+ questionnaire and/or updated medical report.
- Simultaneous participation in another clinical trial or intervention program involving drugs, supplements, or structured physical exercise of any kind.
- Known allergy or intolerance to any component of the nutritional supplement to be administered.
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
Physical activity and Sport Science Faculty, Valencia, Valencia 46010
Valencia, Valencia, 46010
Juan Carlos Colado Sánchez, Chair full professor, juan.colado@uv.es
Juan Carlos Colado Sánchez, Chair full professor
About this study
Official title: Effects of a Nutritional Supplement and Physical Exercise on the Psycho-emotional, Cognitive, Functional, and Neuroendocrine Health of Perimenopausal Women.
The goal of this clinical trial is to learn whether a natural-origin nutritional supplement, combined with a functional exercise program, can improve psycho-emotional, cognitive, functional, and neuroendocrine health in perimenopausal women. The study will also help determine the safety of this combined intervention.
The main questions it aims to answer are:
Read more
- Does the combined intervention improve mood, sleep quality, menopausal symptoms, and cognitive performance?
- Does it enhance physical function and neuroendocrine regulation?
Researchers will compare the supplement to a placebo. All participants will follow the same supervised functional exercise program.
Participants will:
- Take a daily nutritional supplement or placebo for 10 weeks
- Attend three weekly supervised functional exercise sessions (45-60 minutes each)
- Complete pre- and post-intervention evaluations including questionnaires, physical and cognitive tests, and blood samples for biomarker analysis.
Read the detailed description
This study is a randomized, double-blind, placebo-controlled clinical trial with parallel groups, designed to evaluate the effects of a natural-origin nutritional supplement combined with a functional physical exercise program on psycho-emotional, cognitive, functional, and neuroendocrine variables in perimenopausal women. Participants will be randomly assigned to the intervention groups, with both participants and outcome assessors blinded to group allocation (double-blind design). All study groups will receive a functional exercise intervention, in addition to the nutritional supplement or placebo.
The study will last a total of 10 weeks and will include a supervised functional exercise program consisting of three weekly sessions, each lasting 45 to 60 minutes. Pre- and post-intervention assessments will be conducted, including validated questionnaires on sleep quality, mood, general well-being, and menopausal symptoms; objective cognitive tests (attention, working memory, and executive functions); physical fitness assessments (strength, agility, gait speed, body composition); and blood analyses of neuroendocrine biomarkers (cortisol, BDNF, IL-6, TNF-α, GABA, and serotonin).
This methodological design will allow for both within- and between-group comparisons and the analysis of potential interactions between the interventions, in order to determine their efficacy and safety as non-pharmacological strategies to improve the overall health of perimenopausal women.
- Conditions
- Perimenopause, Aging
- Being tested
- Exercise + nutritional supplement, Exercise + placebo supplement
- Keywords
- Perimenopause, nutritional supplement, Functional exercise, Psycho-emotional health, Cognitive function, Non-pharmacological interevention, Randomized controlled trial, Physical function, variable resistance training, Neuroendocrine biomarkers, Sleep and mood regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise + nutritional supplementDietary supplement
Participants in this group will receive an oral daily dose of the natural-origin nutritional supplement in combination with a supervised functional exercise program (3 sessions per week, 45-60 minutes each) for 10 weeks, composed by three exercise blocks: 1) joint mobility and postural control exercises block, 2) functional strength block with three sets of two explosive strength exercises using elastic bands at 70% of 1RM and, 3) coordination and agility exercises block.
Exercise + placebo supplementDietary supplement
Participants in this group will receive an oral placebo supplement identical in appearance to the active supplement, together with the same functional exercise program for 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Exercise + nutritional supplement (Gr 1: EXNS) | Experimental | Participants in this group will receive a daily dose of the natural-origin nutritional supplement in combination with a supervised functional exercise program (3 sessions per week, 45-60 minutes each) for 10 weeks. Receives: Dietary Supplement: Exercise + nutritional supplement |
| Exercise + placebo supplement (Gr 2: EXPLA) | Placebo comparator | Participants in this group will receive a placebo supplement identical in appearance to the active supplement, together with the same functional exercise program for 10 weeks. Receives: Dietary Supplement: Exercise + placebo supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Brain-Derived Neurotrophic Factor (BDNF)
Serum BDNF levels will be collected through a blood sample (ELISA KIT) in the morning in a fasted state to assess neuroplasticity and cognition.
Measured: Before and after the intervention of 10 weeks
Changes in cortisol
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.
Measured: Before and after the intervention of 10 weeks
Changes in inteleukin 6 (IL-6)
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
Measured: Before and after the intervention of 10 weeks
Changes in tumor necrosis factor alfa (TNF-α)
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.
Measured: Before and after the intervention of 10 weeks
Changes in Gamma-aminobutyric acid (GABA)
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.
Measured: Before and after the intervention of 10 weeks
Changes in serotonin
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.
Measured: Before and after the intervention of 10 weeks
Secondary outcomes (16)
Changes in sleep quality
Sleep quality will be assessed through the Pittsburgh Sleep Quality Index (PSQI)
Measured: Before and after the intervention of 10 weeks
Changes in perceived insomnia
Perceived insomnia will be assessed through the Insomnia Severity Index (ISI)
Measured: Before and after the intervention of 10 weeks
Changes in daytime sleepiness
Daytime sleepiness will be assessed through the Epworth Sleepiness Scale (ESS)
Measured: Before and after the intervention of 10 weeks
Changes in state-trait anxiety
State-trait anxiety will be assessed through the State-Trait Anxiety Inventory (STAI-R)
Measured: Before and after the intervention of 10 weeks
Change in depression
Depression will be assessed through the Beck Depression Inventory-II (BDI-II)
Measured: Before and after the intervention of 10 weeks
Changes in general well-being
General well-being will be assessed through the WHO-5 Well-Being Index
Measured: Before and after the intervention of 10 weeks
Changes in menopausal symptoms
Menopausal symptoms will be assessed through the Menopause Rating Scale (MRS)
Measured: Before and after the intervention of 10 weeks
Changes in global cognitive performance
Global cognitive performance will be assessed through the Montreal Cognitive Assessment (MoCA)
Measured: Before and after the intervention of 10 weeks
Changes in working memory
Working memory will be assessed through the Digit Span (WAIS-IV Digit Span subtest - forward and backward)
Measured: Before and after the intervention of 10 weeks
Changes in selective attention
Selective attention will be assessed through the Stroop Test (short version)
Measured: Before and after the intervention of 10 weeks
Changes in processing speed and cognitive flexibility
Processing speed and cognitive flexibility will be assessed through the Trail Making Test A and B (TMT-A/B)
Measured: Before and after the intervention of 10 weeks
Changes in gait speed/aerobic capacity
Gait speed/aerobic capacity will be assessed through the 6-m Walk Test
Measured: Before and after the intervention of 10 weeks
Changes in lower limb strength
Lower limb strength will be assessed through the 30-s Chair Stand Test
Measured: Before and after the intervention of 10 weeks
Changes in handgrip strength
Handgrip strength will be assessed through the Handgrip dynamometry (Jamar Hand Dynamometer).
Measured: Before and after the intervention of 10 weeks
Changes in body composition
Whole body composition will be assessed through the Bioelectrical impedance analysis (Tanita BC-418). Total body mass, fat mass, fat-free mass and percentage of fat free mass will be measured.
Measured: Before and after the intervention of 10 weeks
Adherence to supplement and exercise
Adherence to supplement and exercise will be assessed through ad hoc questionnaire
Measured: Every day for nutritional supplement and each exercise session during the 10 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start15 Dec 2025
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PerimenopauseStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan C. Colado, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251296
- Sponsor's protocol ID
- 2025-FIS-4025659
- Status last verified
- Dec 2025
- First submitted
- 18 Nov 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Nutritional Supplement and Physical Exercise on the Psycho-emotional, Cognitive, Functional, and Neuroendocrine Health of Perimenopausal Women.
- ClinicalTrials.gov ID
- NCT07251296
- Acronym / sponsor ID
- 2025-FIS-4025659
- Conditions
- Perimenopause, Aging
- Keywords
- Perimenopause, nutritional supplement, Functional exercise, Psycho-emotional health, Cognitive function, Non-pharmacological interevention, Randomized controlled trial, Physical function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 26 Nov 2025 (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 goal of this clinical trial is to learn whether a natural-origin nutritional supplement, combined with a functional exercise program, can improve psycho-emotional, cognitive, functional, and neuroendocrine health in perimenopausal women. The study will also help determine the safety of this combined intervention.
The main questions it aims to answer are:
- Does the combined intervention improve mood, sleep quality, menopausal symptoms, and cognitive performance?
- Does it enhance physical function and neuroendocrine regulation?
Researchers will compare the supplement to a placebo. All participants will follow the same supervised functional exercise program.
Participants will:
- Take a daily nutritional supplement or placebo for 10 weeks
- Attend three weekly supervised functional exercise sessions (45-60 minutes each)
- Complete pre- and post-intervention evaluations including questionnaires, physical and cognitive tests, and blood samples for biomarker analysis.
Detailed description
This study is a randomized, double-blind, placebo-controlled clinical trial with parallel groups, designed to evaluate the effects of a natural-origin nutritional supplement combined with a functional physical exercise program on psycho-emotional, cognitive, functional, and neuroendocrine variables in perimenopausal women. Participants will be randomly assigned to the intervention groups, with both participants and outcome assessors blinded to group allocation (double-blind design). All study groups will receive a functional exercise intervention, in addition to the nutritional supplement or placebo.
The study will last a total of 10 weeks and will include a supervised functional exercise program consisting of three weekly sessions, each lasting 45 to 60 minutes. Pre- and post-intervention assessments will be conducted, including validated questionnaires on sleep quality, mood, general well-being, and menopausal symptoms; objective cognitive tests (attention, working memory, and executive functions); physical fitness assessments (strength, agility, gait speed, body composition); and blood analyses of neuroendocrine biomarkers (cortisol, BDNF, IL-6, TNF-α, GABA, and serotonin).
This methodological design will allow for both within- and between-group comparisons and the analysis of potential interactions between the interventions, in order to determine their efficacy and safety as non-pharmacological strategies to improve the overall health of perimenopausal women.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise + nutritional supplement (Gr 1: EXNS) | Experimental | Dietary Supplement: Exercise + nutritional supplementParticipants in this group will receive a daily dose of the natural-origin nutritional supplement in combination with a supervised functional exercise program (3 sessions per week, 45-60 minutes each) for 10 weeks. |
| Exercise + placebo supplement (Gr 2: EXPLA) | Placebo comparator | Dietary Supplement: Exercise + placebo supplementParticipants in this group will receive a placebo supplement identical in appearance to the active supplement, together with the same functional exercise program for 10 weeks. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Women aged between 45 and 65 years.
- In the menopausal transition (defined by irregular menstrual cycles and typical symptoms within the past year) or postmenopause.
- Score ≥ 8 on the Menopause Rating Scale (MRS), indicating moderate menopausal symptom intensity.
- Regular nighttime sleep and not engaged in shift work.
- Low physical activity level: less than 150 minutes per week of moderate or vigorous physical activity, as assessed by the short-form IPAQ or a similar questionnaire.
Key exclusion criteria (8 listed)
- Current or recent (within the last 3 months) use of hormone replacement therapy (HRT).
- Surgical, induced, or early menopause (before age 40).
- Current treatment with medications that may affect mood, sleep, or vasomotor symptoms, including: antidepressants (SSRIs, SNRIs, tricyclics); anxiolytics or hypnotics; phytoestrogens, isoflavones, or other over-the-counter hormonal supplements.
- Medical diagnosis of severe or uncontrolled chronic diseases, including cardiovascular, respiratory (particularly sleep apnea), metabolic, active oncological, neurological, severe autoimmune, or psychiatric disorders.
- Regular use within the past 3 months of nutritional or sports supplements that may interfere with study outcomes (e.g., creatine, protein, omega-3, adaptogens, etc.).
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 |
|---|---|---|
| Exercise + nutritional supplementParticipants in this group will receive an oral daily dose of the natural-origin nutritional supplement in combination with a supervised functional exercise program (3 sessions per week, 45-60 minutes each) for 10 weeks, composed by three exercise blocks: 1) joint mobility and postural control exercises block, 2) functional strength block with three sets of two explosive strength exercises using elastic bands at 70% of 1RM and, 3) coordination and agility exercises block. | Dietary supplement | Exercise + nutritional supplement (Gr 1: EXNS) |
| Exercise + placebo supplementParticipants in this group will receive an oral placebo supplement identical in appearance to the active supplement, together with the same functional exercise program for 10 weeks. | Dietary supplement | Exercise + placebo supplement (Gr 2: EXPLA) |
Primary outcome
Changes in Brain-Derived Neurotrophic Factor (BDNF)
Time frame: 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.
Changes in cortisol
Time frame: 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.
Changes in inteleukin 6 (IL-6)
Time frame: 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
Changes in tumor necrosis factor alfa (TNF-α)
Time frame: 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.
Changes in Gamma-aminobutyric acid (GABA)
Time frame: 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.
Changes in serotonin
Time frame: 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.
16 secondary outcomes
Changes in sleep quality
Time frame: Before and after the intervention of 10 weeks
Changes in perceived insomnia
Time frame: Before and after the intervention of 10 weeks
Changes in daytime sleepiness
Time frame: Before and after the intervention of 10 weeks
Changes in state-trait anxiety
Time frame: Before and after the intervention of 10 weeks
Change in depression
Time frame: Before and after the intervention of 10 weeks
Changes in general well-being
Time frame: Before and after the intervention of 10 weeks
Changes in menopausal symptoms
Time frame: Before and after the intervention of 10 weeks
Changes in global cognitive performance
Time frame: Before and after the intervention of 10 weeks
Changes in working memory
Time frame: Before and after the intervention of 10 weeks
Changes in selective attention
Time frame: Before and after the intervention of 10 weeks
Changes in processing speed and cognitive flexibility
Time frame: Before and after the intervention of 10 weeks
Changes in gait speed/aerobic capacity
Time frame: Before and after the intervention of 10 weeks
Changes in lower limb strength
Time frame: Before and after the intervention of 10 weeks
Changes in handgrip strength
Time frame: Before and after the intervention of 10 weeks
Changes in body composition
Time frame: Before and after the intervention of 10 weeks
Adherence to supplement and exercise
Time frame: Every day for nutritional supplement and each exercise session during the 10 weeks of intervention
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 22 Dec 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise + nutritional supplement in people with Perimenopause and Aging, run by University of Valencia 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 8 inclusion and 8 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 22 Dec 2025. 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?
Contact Juan Carlos Colado Sánchez, Chair full professor ((9639) 83470, juan.colado@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Brain-Derived Neurotrophic Factor (BDNF) (time frame: Before and after the intervention of 10 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Dec 2025.