The Role of Diet Quality in Sleep Among Women in Postmenopause (EMILE)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Post Menopausal Women
• Intervention / Treatment: Behavioral: Intensive High-Fiber Mediterranean Diet Counseling; Behavioral: Low-Intensity Mediterranean Diet Counseling

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 Type: Interventional
• Enrollment (Estimated): 136
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria Izquierdo-Pulido, PhD; Phone Number: +34; Email: maria_izquierdo@ub.edu
• Study Contact Backup: Name: Maria Fernanda Fernanda Zerón-Rugerio, PhD; Email: fernanda.zeron@ub.edu

Study Locations

• Spain
  • Barcelona, Spain, 08041
    • Centro de Investigación del Medicamento (CIM Sant Pau)
    • Contact: Rosa Antonijoan-Arbós, PhD; Phone Number: +34 935 53 78 55; Email: rantonijoana@santpau.cat
    • Sub-Investigator: Isabella Parilli-Moser, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-Fiber Mediterranean Diet With Intensive Counseling; 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; Consists of an intensive nutritional intervention based on a high-fiber Mediterranean diet (target intake: 30-35 g/day of dietary fiber).
Active Comparator: Mediterranean Diet With Low-Intensity 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 receiving low-intensity nutritional counseling on the Mediterranean diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	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	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)	Baseline, weeks 8 and 16.
Changes in Urinary 6-sulphatoxymelatonin From Baseline to Week 8 and 16	Quantified using urine Melatonin-Sulfate ELISA kit	Baseline, weeks 8 and 16.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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)	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)	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)	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.	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.	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.	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.	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.	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.	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.	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.	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.	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).	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.	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.	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.	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.	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.	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.	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	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.	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.	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.	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.	Weeks 2, 4, 6, 10, and 12.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline to week 16.

Collaborators and Investigators

• Sponsor: University of Barcelona
• Collaborators: Ministry of Science and Innovation, Spain
• Investigators: Principal Investigator: Maria Izquierdo-Pulido, PhD, University of Barcelona; Principal Investigator: Maria Fernanda Zeron-Rugerio, PhD, University of Barcelona

Study record dates

Study Major Dates

• Study Start (Estimated): November 17, 2026
• Primary Completion (Estimated): December 20, 2027
• Study Completion (Estimated): May 31, 2028

Study Registration Dates

• First Submitted: October 22, 2026
• First Submitted That Met QC Criteria: November 2, 2026
• First Posted (Actual): November 5, 2026

Study Record Updates

• Last Update Posted (Actual): November 5, 2026
• Last Update Submitted That Met QC Criteria: November 2, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Keywords: Sleep; Dietary fiber; Mediterranean diet; Post menopausal women
• Other Study ID Numbers: PID2023-147086OB-I00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No