Attenuation of Postprandial Inflammatory Processes in Alzheimer's Disease Patients by Consumption of Pomace Oil - Trial NCT06245616

Timeline & Enrollment

Primary Outcome

Postprandial serum triglycerides

Summary

This research project is based on previous studies suggesting that certain components of
 olive pomace oil can reduce inflammation in the brain associated with neurodegenerative
 diseases like Alzheimers. The current hypothesis proposes that particles carrying
 dietary fats can trigger inflammation, but if they contain bioactive compounds from olive
 pomace oil, this inflammatory activity will be reduced.
 
 The study aims to recruit 40 adult volunteers, both men and women, diagnosed with early-stage
 Alzheimers. Participants will be divided into two groups based on their blood
 triglyceride levels. Additionally, 40 healthy individuals with similar ages will be recruited
 and divided into two groups based on their triglyceride levels.
 
 Recruitment will take place at the Neurology Department of Virgen de Valme University
 Hospital in Dos Hermanas, Sevilla. Participants must have a mild stage of Alzheimers,
 allowing intervention through diet for prevention or slowing down disease progression.
 Inclusion criteria include good visual and auditory capabilities, disease monitoring by
 healthcare professionals, and voluntary written consent approved by the hospitals ethics
 committee.
 
 Exclusion criteria involve current medical conditions, medication use (except
 contraceptives), pregnancy or lactation, systemic diseases, cardiovascular events in the last
 two years, uncontrolled hypertension in the last six months, cancer in the last five years,
 recent participation in clinical trials, physical or intellectual limitations, and any
 connection with the study staff.
 
 Participation is voluntary, and participants can withdraw at any time without consequences.
 The study could benefit Alzheimers patients by reducing brain inflammation and oxidative
 stress. For healthcare institutions, it may improve care quality and contribute to prevention
 and treatment policies. Scientifically, it could provide insights into the effects of
 compounds on Alzheimers patients, potentially leading to new treatment strategies. Olive
 pomace oil producers may benefit from supporting the oils marketing and usage with
 health-related information. Overall, the project aims to impact society positively by
 enhancing disease prevention and treatment.
 
 Regarding risks, the study involves minimal blood extraction, posing no significant threat.
 Participants may experience slight discomfort due to the catheter during the six-hour study
 period. Follow-up contact may be necessary, but participants have the right to refuse.
 
 The study will take place at Virgen de Valme University Hospital (Seville), ensuring
 immediate attention in case of unexpected issues. A qualified nurse, supervised by a doctor,
 will conduct the procedures. The study is covered by liability insurance to compensate for
 any health-related issues or injuries during participation.
 
 Two postprandial experiments will be conducted, administering olive pomace oil in one and
 high-oleic sunflower oil in the other. Blood extractions will occur before and hourly for six
 hours after participants consume a meal containing the respective oils, accompanied by bread
 and milk. The food poses no health risks. The blood extraction process involves a simple
 puncture with inherent risks of any standard blood withdrawal procedure.
 
 The participant has the right to clarify any doubts he/she may have at any time and to
 request more detailed information about the research. To do so, the participant can contact
 the researchers, whose contact details are at the beginning of this document.
 
 If the participant considers that all doubts have been clarified and that he/she is convinced
 that the he/she wants to participate in this study, he/she can then sign the informed consent
 form.

ICD-10 Classifications