Effects of a 6-months Fiber- and Polyphenol-rich Diet on Brain Inflammatory Processes in Perimenopausal Women Living With Overweight or Obesity
NCT07501377, Not applicable, Recruiting, Max Planck Institute for Human Cognitive and Brain Sciences
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effects of a 6-months Fiber- and Polyphenol-rich Diet on Brain Inflammatory Processes in Perimenopausal Women Living With Overweight or Obesity | ClinicalTrials.gov |
| NCT number | NCT07501377 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 120 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Max Planck Institute for Human Cognitive and Brain Sciences | ClinicalTrials.gov |
| Conditions | Overweight and/or Obesity, Perimenopausal Women | ClinicalTrials.gov |
| Interventions | Polybiotic dietary intervention, Placebo | ClinicalTrials.gov |
| First posted | 2026-03-30 | ClinicalTrials.gov |
| Last updated | 2026-03-30 | ClinicalTrials.gov |
Registered outcomes 19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Free water fraction averaged across the white matter skeleton | 6 months | Free water (measured using multi-shell diffusion-weighted MRI at 3 Tesla) reflects extra-cellular water which can be considered an indicator of tissue edema and impaired blood brain barrier | ClinicalTrials.gov |
| Secondary | Average grey matter kw from motion-compensated diffusion-weighted arterial spin labeling (ASL) | 6 months | Water exchange rate over the blood-brain barrier will be measured using motion-compensated diffusion-weighted pseudo-continuous arterial-spin labeling (MCDW-ASL) or diffusion-prepared pCASL (DP-pCASL). | ClinicalTrials.gov |
| Secondary | Apparent diffusion coefficient of metabolites in the thalamus from diffusion-weighted MR spectoscropy | 6 months | microglial activity will be quantified by measuring ADCCholine using diffusion-weighted magnetic resonance spectroscopy (dwMRS) | ClinicalTrials.gov |
| Secondary | Hypothalamic and hippocampal microstructure | 6 months | microstructure will be assessed by mean diffusivity (MD) | ClinicalTrials.gov |
| Secondary | Episodic memory | 6 months | California Verbal Learning Task | ClinicalTrials.gov |
| Secondary | Microbial Composition | 6 months | Alpha/Beta diversity and abundance of specific bacteria (e.g. bifidobacteria) from microbiome shotgun sequencing | ClinicalTrials.gov |
| Other | soma signal fraction in thalamus and hippocampus derived from multi-shell diffusion-weighted MRI | 6 months | assessed using multi-shell diffusion-weighted MRI at 3T | ClinicalTrials.gov |
| Other | Pattern separation | 6 months | Dprime and accuracy, reaction time of Mnemonic Similarity Task (MST) | ClinicalTrials.gov |
| Other | Executive function | 6 months | Composite score of executive function tests derived from Trail Making Test, Attention Network Test, Stroop-Test | ClinicalTrials.gov |
| Other | pro-inflammatory marker high-sensitive C-reactive protein (hsCRP) | 6 months | hsCRP measured in fasting blood | ClinicalTrials.gov |
| Other | waist-to-hip ratio, WHR | 6 months | ratio of waist circumeference to hip circumference (measured) | ClinicalTrials.gov |
| Other | Adherence to healthy dietary pattern | 6 months | A composite score based on self-reported information provided through diet protocol and food frequency questionnaire (FFQ) | ClinicalTrials.gov |
| Other | Menopausal symptoms | 6 months | severity of menopausal symptoms based on a questionnaire | ClinicalTrials.gov |
| Other | Assessment of health data | 6 months (during 2 weeks at baseline, and follow-up, respectively) | via wearables - smart devices finger ring and/or watch and glucose patch | ClinicalTrials.gov |
| Other | Demographics, anamnesis | 6 months | Age, sex/gender, medical history, reproductive history, medication | ClinicalTrials.gov |
| Other | Total energy expenditure measured using a metabolic chamber | 6 months | Oxygen consumption and CO2 production measured in a metabolic chamber, determining 24-hour total energy expenditure (TEE) | ClinicalTrials.gov |
| Other | body fat percentage | 6 months | measured using bioelectrical impedance analysis (BIA) | ClinicalTrials.gov |
| Other | Gastrointestinal hormones | 6 months | area under the curve (pre- to postprandial) of glukagon-like peptide 1 (GLP-1) | ClinicalTrials.gov |
| Other | Sex hormones | 6 months | Follicle-stimulating hormon (FSH) measured in blood | 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 6
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 |
|---|---|---|
| Attention Network Test | Other outcome | ConductCognition |
| Mnemonic Similarity Task | Other outcome | ConductCognition |
| Stroop Color-Word Test | Other outcome | ConductCognition |
| Trail Making Test A | Other outcome | ConductCognition |
| Trail Making Test B | Other 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)