Attenuation of Postprandial Inflammatory Processes in Alzheimer's Disease Patients by Consumption of Pomace Oil
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Postprandial serum triglycerides
Study Overview
Brief 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 Alzheimer's. 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 Alzheimer's. 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 Alzheimer's, 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 hospital's 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 Alzheimer's 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 Alzheimer's patients, potentially leading to new treatment strategies. Olive pomace oil producers may benefit from supporting the oil's 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.
Detailed Description
- BACKGROUND
Alzheimer's disease (AD) is the most common cause of dementia and its prevalence is expected to quadruple by 2050. Alzheimer's is characterised pathologically by substantial neuronal loss and chronic inflammation, which is associated with cerebrovascular and parenchymal accumulation of protein deposits enriched in amyloid-beta (Aβ) and hyperphosphorylated Tau protein. Accumulating evidence suggests that disruption of the blood-brain barrier function, which separates the central nervous system from the peripheral circulation, may increase the risk of the onset and worsen the course of AD.
Microglia have been proposed to play a crucial role in most neuropathologies, as they are activated upon detection of alterations in brain homeostasis. This cell type acts like resident macrophages in the brain, constantly scanning the local microenvironment for signs of infection and injury and becoming activated when found. As a result, a host of pro-inflammatory mediators are released, including cytokines, reactive oxygen species (ROS) and nitric oxide. In contrast, antioxidant defence systems, such as glutathione peroxidase-1 and superoxide dismutase-1, are decreased in AD patients.
A significant part of plasma Aβ is associated with triglyceride-rich lipoproteins (TRL) that are secreted from hepatocytes and enterocytes. These particles are characterised by apolipoprotein B, which serves as an indicator of postprandial dyslipidaemia, which is an exaggerated but transient increase in TRL after dietary fat absorption and leads to the formation of atherosclerosis. This phenomenon could be the link between cardiovascular disease and Alzheimer's disease. The existence of such a link has already been demonstrated in clinical and cross-sectional studies, but the underlying mechanism remains unclear.
There is accumulating evidence that dietary fat intake is associated with the onset and progression of Alzheimer's disease. Thus, saturated fatty acid (SFA) intake would be a deleterious factor, promoting dyslipidaemia, endothelial dysfunction, inflammation and oxidative stress. In contrast, consumption of fats rich in poly- or monounsaturated fatty acids (PUFA and MUFA) are associated with lower disease prevalence, probably as a consequence of lower levels of systemic inflammation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Clinical diagnosis of Alzheimer's disease.
- •Adequate visual and hearing abilities.
- •Able to consume breakfast without help.
Exclusion Criteria
- •Clinically significant psychiatric disorders.
- •Systemic disease or infection that could affect safety.
- •Cardiovascular disease within the last 2 years.
- •Uncontrolled hypertension within the last 6 months.
- •Cancer within the last 5 years.
- •Drug or alcohol abuse within the last 2 years.
- •Insulin-dependent diabetes.
Arms & Interventions
Pomace olive oil group
The arm receives a breakfast with pomace olive oil as main fat source.
Intervention: Consumption of olive pomace olive oil by alzheimer's patients (Dietary Supplement)
Pomace olive oil group
The arm receives a breakfast with pomace olive oil as main fat source.
Intervention: Consumption of high-oleic sunflower oil by alzheimer's patients (Dietary Supplement)
High-oleic sunflower oil group
The arm receives a breakfast with high-oleic sunflower oil as main fat source.
Intervention: Consumption of olive pomace olive oil by alzheimer's patients (Dietary Supplement)
High-oleic sunflower oil group
The arm receives a breakfast with high-oleic sunflower oil as main fat source.
Intervention: Consumption of high-oleic sunflower oil by alzheimer's patients (Dietary Supplement)
Outcomes
Primary Outcomes
Postprandial serum triglycerides
Time Frame: 6 hours postprandially
Secondary Outcomes
- Oleanolic acid(6 hours postprandially)
- Apolipoprotein B-100(6 hours postprandially)
- Beta-sitosterol(6 hours postprandially)
- Apolipoprotein B-48(6 hours postprandially)
- Alpha-tocopherol(6 hours postprandially)
Investigators
Javier Sanchez Perona
Principal Investigator
Spanish National Research Council