An interventional study of Intensive High-Fiber Mediterranean Diet Counseling and Low-Intensity Mediterranean Diet Counseling in Post Menopausal Women, sponsored by University of Barcelona. Not yet recruiting at 1 site in Spain. Open to female participants aged 50 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by University of Barcelona · Not applicable, Interventional, and Prevention
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.
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:
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.
University of Barcelona is the lead sponsor of 98 studies on the registry; 29 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Intensive High-Fiber Mediterranean Diet Counseling
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.
Behavioral: Low-Intensity Mediterranean Diet Counseling
Consists of an intensive nutritional intervention based on a high-fiber Mediterranean diet (target intake: 30-35 g/day of dietary fiber).
Consists of receiving low-intensity nutritional counseling on the Mediterranean diet.
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.
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: Baseline, weeks 8 and 16.
Changes in Urinary 6-sulphatoxymelatonin From Baseline to Week 8 and 16
Quantified using urine Melatonin-Sulfate ELISA kit
Time frame: Baseline, weeks 8 and 16.
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.
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Weeks 2, 4, 6, 10, and 12.
Changes in Invisible Family Load from baseline to week 16.
This outcome will be measured through the Invisible Family Load questionnaire to measure the: * Managerial * Cognitive * Emotional load activities to address family's needs, goals, activities, responsibilities, and/or well-being. Higher scores indicate higher managerial, cognitive, and/or emotional load.
Time frame: Baseline and week 16.
Changes in handgrip strenght from baseline to week 16.
Handgrip strength will be assessed using a Jamar Hydraulic Hand Dynamometer. Three maximal grip-strength measurements will be obtained from the dominant hand following a standardized protocol, and the highest value (kg) will be used for analysis.
Time frame: Baseline to week 16.
Plan to share: 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.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Dec 2027, 13 months later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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University of Barcelona