The Role of Diet Quality in Sleep Among Women in Postmenopause
NCT07918287, Not applicable, Not yet recruiting, University of Barcelona
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | The Role of Diet Quality in Sleep Among Women in Postmenopause | ClinicalTrials.gov |
| NCT number | NCT07918287 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 136 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University of Barcelona | ClinicalTrials.gov |
| Conditions | Post Menopausal Women | ClinicalTrials.gov |
| Interventions | Intensive High-Fiber Mediterranean Diet Counseling, Low-Intensity Mediterranean Diet Counseling | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Subjective Sleep Quality From Baseline to Week 8 and 16 | 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. | ClinicalTrials.gov |
| Primary | Changes in Sleep Onset Latency From Baseline to Weeks 8 and 16 | 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) | ClinicalTrials.gov |
| Primary | Changes in Sleep Efficiency From Baseline to Weeks 8 and 16 | 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 | ClinicalTrials.gov |
| Primary | Changes in Wake After Sleep Onset (WASO) From Baseline to Weeks 8 and 16 | Baseline, weeks 8 and 16. | Measured in minutes of WASO with an actigraph (ActTrust, CONDOR, Brazil) | ClinicalTrials.gov |
| Primary | Changes in Urinary 6-sulphatoxymelatonin From Baseline to Week 8 and 16 | Baseline, weeks 8 and 16. | Quantified using urine Melatonin-Sulfate ELISA kit | ClinicalTrials.gov |
| Secondary | Daytime sleepiness From Baseline to Week 16 | Baseline and 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. | ClinicalTrials.gov |
| Secondary | Changes in Body Mass Index (BMI) From Baseline to Weeks 8 and 16 | Baseline, weeks 8 and 16. | Calculated as weight (kg) divided by height (in squared meters), BMI= kg/m\^2 | ClinicalTrials.gov |
| Secondary | Changes in Body Fat From Baseline to Weeks 8 and 16 | Baseline, weeks 8 and 16. | Measured as the percentage of body fat with a body composition analyzer (Inbody 120, Korea) | ClinicalTrials.gov |
| Secondary | Changes in Waist Circumference From Baseline to Weeks 8 and 16 | Baseline, 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) | ClinicalTrials.gov |
| Secondary | Changes in Hip Circumference From Baseline to Weeks 8 and 16 | Baseline, 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) | ClinicalTrials.gov |
| Secondary | Changes in the composition of the gut microbiota from baseline to week 16. | Baseline and 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. | ClinicalTrials.gov |
| Secondary | Changes in intestinal permeability from baseline to week 16. | 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. | ClinicalTrials.gov |
| Secondary | Changes in short-chain fatty acids (SCFAs) from baseline and week 16 | 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. | ClinicalTrials.gov |
| Secondary | Changes in Fasting Blood Glucose From Baseline to Week 16 | Baseline and 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. | ClinicalTrials.gov |
| Secondary | Changes in Total Cholesterol From Baseline to Week 16 | Baseline and 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. | ClinicalTrials.gov |
| Secondary | Changes in HDL Cholesterol From Baseline to Week 16 | Baseline and 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. | ClinicalTrials.gov |
| Secondary | Changes in LDL Cholesterol From Baseline to Week 16 | Baseline and 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. | ClinicalTrials.gov |
| Secondary | Changes in Triglycerides From Baseline to Week 16 | Baseline and 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. | ClinicalTrials.gov |
| Secondary | Changes in Glycated Hemoglobin (HbA1c) From Baseline to Week 16 | Baseline and 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. | ClinicalTrials.gov |
| Secondary | Changes in diet quality from baseline to week 16. | Baseline and 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). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Corsi Block-Tapping Test | Secondary outcome | ConductCognition |
| Finger Tapping Task | Secondary outcome | ConductCognition |
| Task Switching Test | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)