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New treatment option for Overweight and/or Obesity
Official 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 ID: NCT07501377
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 35 to 60, women only. Healthy volunteers may be eligible.
You may be able to join if
- STRAW+10 -1 or -2
- BMI \> 25 or WHR \>= 0.85
- hsCRP \> 1 mg/l
- no MRI contra-indication
- written informed consent
You likely can't join if
- 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.)...
- Polycystic ovary syndrome, total ovarectomy
See the full eligibility criteria
- STRAW+10 -1 or -2
- BMI \> 25 or WHR \>= 0.85
- hsCRP \> 1 mg/l
- no MRI contra-indication
- written informed consent
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Leipzig, Saxony, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 35 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leipzig, Saxony, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.