Effects of a 6-months Fiber- and Polyphenol-rich Diet on Brain Inflammatory Processes in Perimenopausal Women Living With Overweight or Obesity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Polybiotic dietary intervention, Placebo.
- Who it may be relevant to
- Registry conditions: Overweight and/or Obesity, Perimenopausal Women. Basic parameters: 35 years — 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of a Fiber- and Polyphenol-rich Diet on Brain Inflammatory Processes in Obesity
Overview
People living with obesity have a higher risk of late-life cognitive decline and developing dementia. In women, the risk of cognitive decline may further raise during the menopausal transition, a period of substantial hormonal and metabolic changes. Recent studies suggest that a healthy diet could help to prevent neurocognitive disorders by reducing inflammatory processes in the body and brain. Emerging evidence further indicates that the gut-brain axis and the intestinal microbiome play a crucial role in mediating this effect, through metabolic, immune, neuronal and vascular routes. Modifying the gut microbiota may thus counteract the heightened systemic inflammation seen in obesity and during menopausal transition to eventually benefit brain health. Specifically, plant-based nutirents, such as fibre and polyphenols, have microbiome-changing, anti-inflammatory and neuroprotective properties that may slow brain aging and neuro-inflammation. However, evidence from human interventional studies and knowledge on the underlying mechanisms remain scarce. This randomized controlled trial will therefore test whether altering gut bacteria through six months of daily intake of a personalized "polybiotic" dietary formula, compared to placebo, improves markers of brain health in women during the perimenopausal transition that are living with overweight or obesity. We plan to enroll 120 women aged 35-60 with overweight/obesity and elevated inflammatory blood markers, randomized to: intervention (7.5 or 15 g inulin, plus 200 mg resveratrol and 320 mg quercetin per day in powder form with main meals) or control (isocaloric maltodextrin). Exclusions include type 1 diabetes, current psychiatric/gastrointestinal disorders, and magentic resonance imaging (MRI) contraindications. Before and after 26 weeks, participants will undergo brain MRI to assess inflammation-related brain markers, neuropsychological testing, anthropometric measurements, they will fill in a set of questionnaires and donate stool and blood. Gut bacteria will be profiled by next-generation sequencing; metabolites will be measured in blood and stool. The primary outcome is a proxy of neuroinflammation in the white matter assessed using diffusion-weighted MRI. Secondary analyses will examine blood-brain-barrier permeability and other functional and structural MRI measures, including MR spectoscropy. Mechanistic links among changes in inflammatory markers, microbiota composition, and short-chain fatty acids will be explored using path and network models. This study may help to develop novel prevention and treatment strategies to mitigate obesity-related cognitive decline via the gut-brain axis.
Interventions
- Dietary supplement Polybiotic dietary intervention
7.5g or 15g of inulin + 200mg resveratrol + 320mg quercetin in a powder formula - Dietary supplement Placebo
Equicaloric maltodextrin in powder form
Primary outcome measures
- Free water fraction averaged across the white matter skeleton [Time frame: 6 months]
Secondary outcome measures (5)
- Average grey matter kw from motion-compensated diffusion-weighted arterial spin labeling (ASL) [Time frame: 6 months]
- Apparent diffusion coefficient of metabolites in the thalamus from diffusion-weighted MR spectoscropy [Time frame: 6 months]
- Hypothalamic and hippocampal microstructure [Time frame: 6 months]
- Episodic memory [Time frame: 6 months]
- Microbial Composition [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- STRAW+10 -1 or -2
- BMI > 25 or WHR >= 0.85
- hsCRP > 1 mg/l
- no MRI contra-indication
- written informed consent
Exclusion criteria
- occurrence of a clinically relevant psychiatric disease in the last 12 months (e.g., depression, substance abuse, eating disorder, schizophrenia)
- type 1 diabetes
- previous bariatric/gastric surgery
- pregnancy or breastfeeding woman
- severe untreated disease, cancer treatment last 12 months, any chronic gastric tract disease (IBS, Morbus Crohn, Heliobacter pylori Infection etc.) or any chronic inflammatory disease
- Polycystic ovary syndrome, total ovarectomy
- Intake of antibiotics in past 3 months, intake of inulin (>5g/day) or polyphenol supplementation (>50mg/day) in past 3 months
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Basic science
Study locations
Germany · 1 center
- Max Planck Institute for Human Cognitive and Brain Sciences — Leipzig
Identifiers
NCT: NCT07501377 · NRO-286