Post Menopausal WomenEMILENCT07918287
The Role of Diet Quality in Sleep Among Women in Postmenopause
A study testing Intensive High-Fiber Mediterranean Diet Counseling and Low-Intensity Mediterranean Diet Counseling in people with Post Menopausal Women, run by University of Barcelona at 1 site in Spain.
Trial summary
This single-center, randomized controlled trial with parallel groups, consists of an intensive nutritional intervention based on a high-fiber Mediterranean diet (target intake: 30-35 g/day of dietary fiber), which will be compared with a control group receiving low-intensity nutritional counseling on the Mediterranean… Read more about this study
- Who is it for?
- Ages 50 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Menopausal Women
- What is being tested?
- Intensive High-Fiber Mediterranean Diet Counseling and Low-Intensity Mediterranean Diet Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteSpain
- Study dates
- 17 Nov 2026to 31 May 2028
- 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 50 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Postmenopausal women aged 50 to 60 years
- Having a poor subjective sleep quality (assessed using the Pittsburgh Sleep Quality Index, with scores of 5 points or higher)
- Having a BMI between 20 and 30 kg/m²
- Performing a moderate level of physical activity
- Having no recent history of weight changes greater than 2-3 kg during the previous 3 months.
Who cannot join
- Having any acute, chronic, or psychiatric illness
- Being current smoker
- Taking antibiotics
- Following a specific diet or have dietary restrictions
- Work rotating or night shifts
- Have undergone bariatric surgery or endoscopic bariatric procedures
- Being unable to provide written informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Maria Fernanda Fernanda Zerón-Rugerio, PhD contact
Spain1 site
Centro de Investigación del Medicamento (CIM Sant Pau)
Barcelona, 08041
Rosa Antonijoan-Arbós, PhD, +34 935 53 78 55, rantonijoana@santpau.cat
Isabella Parilli-Moser, PhD
About this study
Official title: The Impact of Diet Quality and Gut Microbiota on Sleep Quality in Postmenopausal Women
This single-center, randomized controlled trial with parallel groups, consists of an intensive nutritional intervention based on a high-fiber Mediterranean diet (target intake: 30-35 g/day of dietary fiber), which will be compared with a control group receiving low-intensity nutritional counseling on the Mediterranean diet. The intervention will last 16 weeks, followed by an 8-month follow-up period to evaluate its impact and the sustainability of long-term effects.
Participants allocated to the intervention group will receive nutritional counseling and guidance to achieve the intervention target of a daily dietary fiber intake of 30 to 35 g. To this end, they will be provided with a personalized weekly meal plan and will undergo intensive follow-up throughout the intervention period.
Participants in the control group will receive educational materials on how to follow a Mediterranean diet; however, no specific dietary fiber intake targets will be established, and they will not receive a personalized weekly meal plan.
Read the detailed description
Eligible volunteers will be invited to participate in this 16-week parallel-group randomized controlled trial. All eligible participants will receive detailed information about the study and provide written informed consent prior to enrollment. Upon enrollment, participants will be assigned a unique identification code to maintain the confidentiality of their data throughout the study.
Participants will then attend a baseline assessment visit (T0), during which data on all study variables will be collected and a blood sample will be obtained for the assessment of cardiometabolic parameters. During this visit, participants will also receive instructions and materials for the assessment of sleep quality, including an actigraph to be worn on the non-dominant wrist for seven consecutive days, as well as materials and guidance for the collection of biological samples (urine and stool).
After seven days, participants will return to the study site to return the actigraph and biological samples. In addition, during this visit, they will be randomly assigned to either the intervention or control arm of the trial and will receive nutritional information according to their allocated group. After receiving the corresponding dietary instructions, participants will be asked to commence the intervention allocated to their study arm.
All participants will attend two main study visits: a baseline visit (T0) and a final assessment visit at week 16 (T2), during which all study outcomes will be evaluated. In addition, a sleep-monitoring visit will be conducted at week 8 (T1) to assess sleep-related parameters.
Follow-up procedures will differ according to group allocation:
- Intervention group: Participants will receive individualized telehealth nutrition counseling at weeks 4 and 12, together with telehealth follow-up visits at weeks 2, 6, 10, and 14.
- Control group: Participants will receive telehealth follow-up visits at weeks 4 and 12 and brief follow-up telephone calls at weeks 2, 6, 10, and 14, without nutrition counseling.
Throughout the intervention period, participants in both groups will be encouraged to maintain regular contact with the research team and to report any adverse events or relevant changes in their health status.
- Conditions
- Post Menopausal Women
- Being tested
- Intensive High-Fiber Mediterranean Diet Counseling, Low-Intensity Mediterranean Diet Counseling
- Keywords
- Mediterranean diet, Dietary fiber, Sleep, Post menopausal women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive High-Fiber Mediterranean Diet CounselingBehavioural
Consists of an intensive nutritional intervention based on a high-fiber Mediterranean diet (target intake: 30-35 g/day of dietary fiber).
Low-Intensity Mediterranean Diet CounselingBehavioural
Consists of receiving low-intensity nutritional counseling on the Mediterranean diet.
| Study group | Role | What they receive |
|---|---|---|
| High-Fiber Mediterranean Diet With Intensive Counseling | Experimental | Participants assigned to this arm will follow a high-fiber Mediterranean diet targeting a daily dietary fiber intake of 30-35 g for 16 weeks. They will receive individualized nutritional counseling, a personalized weekly meal plan, and intensive follow-up to support adherence to the dietary recommendations. Receives: Behavioral: Intensive High-Fiber Mediterranean Diet Counseling |
| Mediterranean Diet With Low-Intensity Counseling | Active comparator | Participants assigned to this arm will receive low-intensity nutritional guidance on following a Mediterranean diet for 16 weeks. They will be provided with educational materials on Mediterranean dietary recommendations, without specific dietary fiber intake targets or personalized weekly meal plans. Receives: Behavioral: Low-Intensity Mediterranean Diet Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Sleep Quality From Baseline to Week 8 and 16
The Spanish version of the Pittsburgh Sleep Quality Index (PSQI) will be used to assess subjective sleep quality. The global score is calculated by summing seven component scores, resulting in a total score ranging from 0 to 21. Higher scores indicate poorer sleep quality.
Measured: Baseline, weeks 8 and 16.
Changes in Sleep Onset Latency From Baseline to Weeks 8 and 16
Defined as the length of time, in min, it takes to transition from wake to sleep onset. Measured with an actigraph (ActTrust, CONDOR, Brazil)
Measured: Baseline, weeks 8 and 16.
Changes in Sleep Efficiency From Baseline to Weeks 8 and 16
Calculated in percentage as the ratio of total sleep time (TST) to time in bed (TIB).
Sleep efficiency (percent) = (TST/TIB)*100
Measured: Baseline, weeks 8 and 16.
Changes in Wake After Sleep Onset (WASO) From Baseline to Weeks 8 and 16
Measured in minutes of WASO with an actigraph (ActTrust, CONDOR, Brazil)
Measured: Baseline, weeks 8 and 16.
Changes in Urinary 6-sulphatoxymelatonin From Baseline to Week 8 and 16
Quantified using urine Melatonin-Sulfate ELISA kit
Measured: Baseline, weeks 8 and 16.
Secondary outcomes (26)
Daytime sleepiness From Baseline to Week 16
The Epworth Sleepiness Scale (ESS) will be used to assess daytime sleepiness. The questionnaire consists of eight items, each scored from 0 to 3, yielding a total score ranging from 0 to 24. Higher scores indicate greater daytime sleepiness.
Measured: Baseline and week 16.
Changes in Body Mass Index (BMI) From Baseline to Weeks 8 and 16
Calculated as weight (kg) divided by height (in squared meters), BMI= kg/m^2
Measured: Baseline, weeks 8 and 16.
Changes in Body Fat From Baseline to Weeks 8 and 16
Measured as the percentage of body fat with a body composition analyzer (Inbody 120, Korea)
Measured: Baseline, weeks 8 and 16.
Changes in Waist Circumference From Baseline to Weeks 8 and 16
Measured midway between the lower rib margin and the iliac crest with the subject standing and wearing only underwear, at the end of gentle expiration with an anthropometric tape (CESCORF, Brazil)
Measured: Baseline, weeks 8 and 16.
Changes in Hip Circumference From Baseline to Weeks 8 and 16
Measured at the level of the greater trochanter, at the widest portion of the buttocks with an anthropometric tape (CESCORF, Brazil)
Measured: Baseline, weeks 8 and 16.
Changes in the composition of the gut microbiota from baseline to week 16.
The composition and functionality of the gut microbiota will be assessed in collected samples through sequencing of the 16S rRNA gene fragment (V3-V4 region). Sequencing will be performed using the Illumina MiSeq 300 × 2 platform (Illumina Inc., San Diego, CA, USA), and sequence reads will be merged and processed using the MiSeq Run and MiSeq Reporter software packages.
From this data we will estimate:
- Alpha diversity: defined as the number of observed operational taxonomic units (OTUs; representing richness), through Pielou's evenness index and Shannon diversity indices.
- Beta diversity will be assessed using the unweighted UniFrac distance.
- Taxonomic assignment of phylotypes will be performed using a Bayesian classifier trained on the SILVA database, version 132, which includes full-length sequences clustered at 99% OTU similarity.
Measured: Baseline and week 16.
Changes in intestinal permeability from baseline to week 16.
Intestinal permeability will be evaluated by measuring two widely used biomarkers, calprotectin and zonulin, in fecal samples using ELISA kits (MyBioSource, San Diego, CA, USA). Lower concentrations of calprotectin and zonulin indicate improved intestinal barrier function and suggest reduced intestinal permeability.
Measured: Baseline to week 16
Changes in short-chain fatty acids (SCFAs) from baseline and week 16
SCFAs will be quantified will be quantified using a headspace gas chromatography-mass spectrometry (HS-GC-MS)-based method. Higher concentrations of short-chain fatty acids, particularly butyric acid, will be indicative of greater dietary fiber intake.
Measured: Baseline and week 16.
Changes in Fasting Blood Glucose From Baseline to Week 16
Serum levels of Glucose (mg/dL) will be determined according to the procedures and protocols established by the Biochemical Analysis Laboratory of Sant Pau Hospital.
Measured: Baseline and week 16
Changes in Total Cholesterol From Baseline to Week 16
Serum levels of Total cholesterol (mg/dL) will be determined according to the procedures and protocols established by the Biochemical Analysis Laboratory of Sant Pau Hospital.
Measured: Baseline and week 16
Changes in HDL Cholesterol From Baseline to Week 16
Serum levels of High-density lipoprotein cholesterol (HDL-C) (mg/dL) will be determined according to the procedures and protocols established by the Biochemical Analysis Laboratory of Sant Pau Hospital.
Measured: Baseline and week 16
Changes in LDL Cholesterol From Baseline to Week 16
Serum levels of Low-density lipoprotein cholesterol (LDL-C) (mg/dL) will be determined according to the procedures and protocols established by the Biochemical Analysis Laboratory of Sant Pau Hospital.
Measured: Baseline and week 16
Changes in Triglycerides From Baseline to Week 16
Serum levels of Triglycerides (mg/dL) will be determined according to the procedures and protocols established by the Biochemical Analysis Laboratory of Sant Pau Hospital.
Measured: Baseline and week 16
Changes in Glycated Hemoglobin (HbA1c) From Baseline to Week 16
Serum levels of Glycated hemoglobin (HbA1c) (%) will be determined according to the procedures and protocols established by the Biochemical Analysis Laboratory of Sant Pau Hospital.
Measured: Baseline and week 16
Changes in diet quality from baseline to week 16.
Diet quality will be assessed using the Mediterranean Diet Adherence Screener, which has been validated for the Spanish population. This questionnaire evaluates dietary habits such as daily consumption of fruits and vegetables, regular intake of legumes and fish, and preference for olive oil as the main culinary fat. Each item is scored as either 0 or 1, depending on whether the response is negative (0) or affirmative (1). Based on the total score, adherence to the Mediterranean diet is classified as low (0-5 points), moderate (6-9 points), or high (≥10 points).
Measured: Baseline and week 16
Changes in eating behavior from baseline to week 16
This variable will be assessed using the Three-Factor Eating Questionnaire (TFEQ-R21C). This questionnaire consists of 21 items designed to evaluate the following dimensions of eating behavior:
- Cognitive restraint, which refers to an individual's conscious effort to control food intake in order to maintain or lose weight.
- Uncontrolled eating, which reflects the tendency to overeat in response to a perceived loss of control over eating.
- Emotional eating, which refers to the tendency to overeat when an individual is unable to cope with negative emotional situations or mood states.
Scores for each dimension are calculated as the mean of all items within that dimension, with higher scores indicating a greater expression of the corresponding eating behavior.
Measured: Baseline and week 16.
Changes in neuropsychological performance from baseline to week 16
These outcomes will be assessed using a computerized test battery administered with E-Prime 3.0 software (Psychology Software Tools, USA). Test results will be recorded automatically by the software and exported directly to the investigator's computer. The assessment battery will last approximately 45-50 minutes and will include the following tasks:
- Rey Auditory Verbal Learning Task, which assesses verbal memory and learning.
- Corsi Blocks Task, which asesses visuospatial working memory
- Task Switching Task (TST), which assesses attention and cognitive flexibility.
- Finger Tapping Task (FTT), which assesses motor speed and dexterity.
Measured: Baseline to week 16.
Changes in mental fatigue from baseline to week 16
Assessed using a visual analog or numeric rating scale integrated into the computerized battery. Participants will rate their perceived level of mental fatigue at the time of assessment.
Measured: Baseline and week 16
Changes in anxiety and depression symptoms from baseline to week 16.
The Hospital Anxiety and Depression Scale (HADS) consists of 14 items divided into two seven-item subscales assessing anxiety (HADS-A) and depression (HADS-D). Each subscale yields a score ranging from 0 to 21, with higher scores indicating greater severity of anxiety or depressive symptoms, respectively.
Measured: Baseline and week 16.
Changes in well-being from baseline to week 16.
The World Health Organization-Five Well-Being Index (WHO-5) will be used to assess subjective mental well-being. The questionnaire comprises five items, each scored from 0 to 5, yielding a raw total score ranging from 0 to 25. Higher scores indicate better mental well-being.
Measured: Baseline to week 16.
Changes in health-related quality of life for menopausal women from baseline to week 16
Health-related quality of life will be assessed using the Cervantes Scale, a 31-item questionnaire specifically developed for menopausal women. The total score ranges from 0 to 155, with higher scores indicating poorer health-related quality of life.
Measured: Baseline to week 16
Changes in food noise from baseline to week 16
Food noise will be assessed using the Food Noise Questionnaire (FNQ), a five-item instrument measuring the frequency and intrusiveness of food-related thoughts. Each item is scored from 0 to 4, yielding a total score ranging from 0 to 20. Higher scores indicate greater food noise
Measured: Baseline and week 16.
Changes in physical activity from baseline to week 16
Physical activity levels will be measured in Metabolic Equivalents of Task (METs) using the short version of the International Physical Activity Questionnaire (IPAQ), validated in the Spanish population . Higher scores reflect a greater intensity of physical activity.
Additionally, physical activity levels will be objectively measured using an actigraphy device (ActTrust, Condor, Brazil), as the mean value of motor activity. Higher values reflect a greater intensity of motor activity.
Measured: Baseline and week 16.
Changes in flourishing from baseline to week 16
Flourishing will be assessed using the eight-item Flourishing Scale. Each item is rated on a seven-point Likert scale from 1 to 7, yielding a total score ranging from 8 to 56. Higher scores indicate greater psychological flourishing.
Measured: Baseline and week 16.
Changes in 3-day dietary intake from baseline to week 16.
Dietary intake will be evaluated throug a 3-day image-based dietary records. Data from dietary records will be processed by a registered dietitian using PCN Pro 1.0 software to estimate the average daily energy (kcal/day) and nutrient intake.
Measured: Baseline and week 16.
Adherence to the Dietary Intervention
Adherence to the intervention will be subjectively assessed by the dietitian using a 4-point ordinal scale:
- 3 = Very good adherence: Consistent adherence to the dietary recommendations.
- 2 = Good adherence: Occasional deviations from dietary recommendations.
- 1 = Moderate adherence: Adherence during weekdays but not on weekends.
- 0 = Poor adherence: Failure to follow the dietary recommendations.
Measured: Weeks 2, 4, 6, 10, and 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start17 Nov 2026 (estimated)
- Primary completion20 Dec 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Menopausal WomenStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Innovation, Spain
- Responsible party
- Principal investigator, Dra. Maria Izquierdo-Pulido, University of Barcelona
- Investigators
- Maria Izquierdo-Pulido, PhD, Principal investigator, University of BarcelonaMaria Fernanda Zeron-Rugerio, PhD, Principal investigator, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07918287
- Sponsor's protocol ID
- PID2023-147086OB-I00
- Acronym
- EMILE
- Status last verified
- Nov 2026
- First submitted
- 22 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data collected from human participants are not available publicly for confidentiality reasons, but they will be made available by the PI, Maria Izquierdo-Pulido (maria\_izquierdo@ub.edu), upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Diet Quality and Gut Microbiota on Sleep Quality in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT07918287
- Acronym / sponsor ID
- EMILE / PID2023-147086OB-I00
- Conditions
- Post Menopausal Women
- Keywords
- Mediterranean diet, Dietary fiber, Sleep, Post menopausal women
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Collaborators
- Ministry of Science and Innovation, Spain
- Study start
- 17 Nov 2026 (estimated)
- Primary completion
- 20 Dec 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 5 Nov 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.
This single-center, randomized controlled trial with parallel groups, consists of an intensive nutritional intervention based on a high-fiber Mediterranean diet (target intake: 30-35 g/day of dietary fiber), which will be compared with a control group receiving low-intensity nutritional counseling on the Mediterranean diet. The intervention will last 16 weeks, followed by an 8-month follow-up period to evaluate its impact and the sustainability of long-term effects.
Participants allocated to the intervention group will receive nutritional counseling and guidance to achieve the intervention target of a daily dietary fiber intake of 30 to 35 g. To this end, they will be provided with a personalized weekly meal plan and will undergo intensive follow-up throughout the intervention period.
Participants in the control group will receive educational materials on how to follow a Mediterranean diet; however, no specific dietary fiber intake targets will be established, and they will not receive a personalized weekly meal plan.
Detailed description
Eligible volunteers will be invited to participate in this 16-week parallel-group randomized controlled trial. All eligible participants will receive detailed information about the study and provide written informed consent prior to enrollment. Upon enrollment, participants will be assigned a unique identification code to maintain the confidentiality of their data throughout the study.
Participants will then attend a baseline assessment visit (T0), during which data on all study variables will be collected and a blood sample will be obtained for the assessment of cardiometabolic parameters. During this visit, participants will also receive instructions and materials for the assessment of sleep quality, including an actigraph to be worn on the non-dominant wrist for seven consecutive days, as well as materials and guidance for the collection of biological samples (urine and stool).
After seven days, participants will return to the study site to return the actigraph and biological samples. In addition, during this visit, they will be randomly assigned to either the intervention or control arm of the trial and will receive nutritional information according to their allocated group. After receiving the corresponding dietary instructions, participants will be asked to commence the intervention allocated to their study arm.
All participants will attend two main study visits: a baseline visit (T0) and a final assessment visit at week 16 (T2), during which all study outcomes will be evaluated. In addition, a sleep-monitoring visit will be conducted at week 8 (T1) to assess sleep-related parameters.
Follow-up procedures will differ according to group allocation:
- Intervention group: Participants will receive individualized telehealth nutrition counseling at weeks 4 and 12, together with telehealth follow-up visits at weeks 2, 6, 10, and 14.
- Control group: Participants will receive telehealth follow-up visits at weeks 4 and 12 and brief follow-up telephone calls at weeks 2, 6, 10, and 14, without nutrition counseling.
Throughout the intervention period, participants in both groups will be encouraged to maintain regular contact with the research team and to report any adverse events or relevant changes in their health status.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Fiber Mediterranean Diet With Intensive Counseling | Experimental | Behavioral: Intensive High-Fiber Mediterranean Diet CounselingParticipants assigned to this arm will follow a high-fiber Mediterranean diet targeting a daily dietary fiber intake of 30-35 g for 16 weeks. They will receive individualized nutritional counseling, a personalized weekly meal plan, and intensive follow-up to support adherence to the dietary recommendations. |
| Mediterranean Diet With Low-Intensity Counseling | Active comparator | Behavioral: Low-Intensity Mediterranean Diet CounselingParticipants assigned to this arm will receive low-intensity nutritional guidance on following a Mediterranean diet for 16 weeks. They will be provided with educational materials on Mediterranean dietary recommendations, without specific dietary fiber intake targets or personalized weekly meal plans. |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Postmenopausal women aged 50 to 60 years
- Having a poor subjective sleep quality (assessed using the Pittsburgh Sleep Quality Index, with scores of 5 points or higher)
- Having a BMI between 20 and 30 kg/m²
- Performing a moderate level of physical activity
- Having no recent history of weight changes greater than 2-3 kg during the previous 3 months.
Key exclusion criteria (7 listed)
- Having any acute, chronic, or psychiatric illness
- Being current smoker
- Taking antibiotics
- Following a specific diet or have dietary restrictions
- Work rotating or night shifts
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 |
|---|---|---|
| Intensive High-Fiber Mediterranean Diet CounselingConsists of an intensive nutritional intervention based on a high-fiber Mediterranean diet (target intake: 30-35 g/day of dietary fiber). | Behavioural | High-Fiber Mediterranean Diet With Intensive Counseling |
| Low-Intensity Mediterranean Diet CounselingConsists of receiving low-intensity nutritional counseling on the Mediterranean diet. | Behavioural | Mediterranean Diet With Low-Intensity Counseling |
Primary outcome
Subjective Sleep Quality From Baseline to Week 8 and 16
Time frame: Baseline, weeks 8 and 16.
The Spanish version of the Pittsburgh Sleep Quality Index (PSQI) will be used to assess subjective sleep quality. The global score is calculated by summing seven component scores, resulting in a total score ranging from 0 to 21. Higher scores indicate poorer sleep quality.
Changes in Sleep Onset Latency From Baseline to Weeks 8 and 16
Time frame: Baseline, weeks 8 and 16.
Defined as the length of time, in min, it takes to transition from wake to sleep onset. Measured with an actigraph (ActTrust, CONDOR, Brazil)
Changes in Sleep Efficiency From Baseline to Weeks 8 and 16
Time frame: Baseline, weeks 8 and 16.
Calculated in percentage as the ratio of total sleep time (TST) to time in bed (TIB). Sleep efficiency (percent) = (TST/TIB)*100
Changes in Wake After Sleep Onset (WASO) From Baseline to Weeks 8 and 16
Time frame: Baseline, weeks 8 and 16.
Measured in minutes of WASO with an actigraph (ActTrust, CONDOR, Brazil)
Changes in Urinary 6-sulphatoxymelatonin From Baseline to Week 8 and 16
Time frame: Baseline, weeks 8 and 16.
Quantified using urine Melatonin-Sulfate ELISA kit
26 secondary outcomes
Daytime sleepiness From Baseline to Week 16
Time frame: Baseline and week 16.
Changes in Body Mass Index (BMI) From Baseline to Weeks 8 and 16
Time frame: Baseline, weeks 8 and 16.
Changes in Body Fat From Baseline to Weeks 8 and 16
Time frame: Baseline, weeks 8 and 16.
Changes in Waist Circumference From Baseline to Weeks 8 and 16
Time frame: Baseline, weeks 8 and 16.
Changes in Hip Circumference From Baseline to Weeks 8 and 16
Time frame: Baseline, weeks 8 and 16.
Changes in the composition of the gut microbiota from baseline to week 16.
Time frame: Baseline and week 16.
Changes in intestinal permeability from baseline to week 16.
Time frame: Baseline to week 16
Changes in short-chain fatty acids (SCFAs) from baseline and week 16
Time frame: Baseline and week 16.
Changes in Fasting Blood Glucose From Baseline to Week 16
Time frame: Baseline and week 16
Changes in Total Cholesterol From Baseline to Week 16
Time frame: Baseline and week 16
Changes in HDL Cholesterol From Baseline to Week 16
Time frame: Baseline and week 16
Changes in LDL Cholesterol From Baseline to Week 16
Time frame: Baseline and week 16
Changes in Triglycerides From Baseline to Week 16
Time frame: Baseline and week 16
Changes in Glycated Hemoglobin (HbA1c) From Baseline to Week 16
Time frame: Baseline and week 16
Changes in diet quality from baseline to week 16.
Time frame: Baseline and week 16
Changes in eating behavior from baseline to week 16
Time frame: Baseline and week 16.
Changes in neuropsychological performance from baseline to week 16
Time frame: Baseline to week 16.
Changes in mental fatigue from baseline to week 16
Time frame: Baseline and week 16
Changes in anxiety and depression symptoms from baseline to week 16.
Time frame: Baseline and week 16.
Changes in well-being from baseline to week 16.
Time frame: Baseline to week 16.
Changes in health-related quality of life for menopausal women from baseline to week 16
Time frame: Baseline to week 16
Changes in food noise from baseline to week 16
Time frame: Baseline and week 16.
Changes in physical activity from baseline to week 16
Time frame: Baseline and week 16.
Changes in flourishing from baseline to week 16
Time frame: Baseline and week 16.
Changes in 3-day dietary intake from baseline to week 16.
Time frame: Baseline and week 16.
Adherence to the Dietary Intervention
Time frame: Weeks 2, 4, 6, 10, and 12.
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 5 Nov 2026.
- Individual participant dataSharing planned: Yes. The data collected from human participants are not available publicly for confidentiality reasons, but they will be made available by the PI, Maria Izquierdo-Pulido (maria_izquierdo@ub.edu), upon reasonable request.
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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.
Maria Fernanda Fernanda Zerón-Rugerio, PhD contact
Maria Izquierdo-Pulido, PhD principal investigator
University of Barcelona
Maria Fernanda Zeron-Rugerio, PhD principal investigator
University of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive High-Fiber Mediterranean Diet Counseling and Low-Intensity Mediterranean Diet Counseling in people with Post Menopausal Women, run by University of Barcelona 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 7 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: opening soon, as of the sponsor's last update on 5 Nov 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. 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 Maria Izquierdo-Pulido, PhD (+34, maria_izquierdo@ub.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Sleep Quality From Baseline to Week 8 and 16 (time frame: Baseline, weeks 8 and 16.). The study lists 5 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 5 Nov 2026.