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

NCT06245616 | Active Not Recruiting

• 1 other identifier: 20225869
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease

Keywords

alzheimer's; inflammation; postprandial; pomace olive oil; lipoproteins; bioactive compounds; microglia; triglycerides

Outcome Measures

Primary Outcomes (1)

• Postprandial serum triglycerides

  6 hours postprandially

Secondary Outcomes (5)

• Apolipoprotein B-48

  6 hours postprandially

• Oleanolic acid

  6 hours postprandially

• Alpha-tocopherol

  6 hours postprandially

• Beta-sitosterol

  6 hours postprandially

• Apolipoprotein B-100

  6 hours postprandially

Study Arms (2)

Pomace olive oil group

EXPERIMENTAL

The arm receives a breakfast with pomace olive oil as main fat source.

Dietary Supplement: Consumption of olive pomace olive oil by alzheimer's patients; Dietary Supplement: Consumption of high-oleic sunflower oil by alzheimer's patients

High-oleic sunflower oil group

ACTIVE COMPARATOR

The arm receives a breakfast with high-oleic sunflower oil as main fat source.

Dietary Supplement: Consumption of olive pomace olive oil by alzheimer's patients; Dietary Supplement: Consumption of high-oleic sunflower oil by alzheimer's patients

Interventions

Consumption of high-oleic sunflower oil by alzheimer's patients DIETARY_SUPPLEMENT

Consumption of high-oleic sunflower oil by alzheimer's patients Consumption of olive pomace olive oil by alzheimer's patients as part of a breakfast containing 3 bread slices and coffee with or without skimmed milk.

High-oleic sunflower oil group; Pomace olive oil group

Consumption of olive pomace olive oil by alzheimer's patients DIETARY_SUPPLEMENT

Consumption of olive pomace olive oil by alzheimer's patients as part of a breakfast containing 3 bread slices and coffee with or without skimmed milk.

High-oleic sunflower oil group; Pomace olive oil group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of Alzheimer's disease.
• Adequate visual and hearing abilities.
• Able to consume breakfast without help.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Spanish National Research Council: lead

Study Sites (1)

Hospital Virgen de Valme

Seville, 41014, Spain

Location

Related Publications (16)

• Brookmeyer R, Johnson E, Ziegler-Graham K, Arrighi HM. Forecasting the global burden of Alzheimer's disease. Alzheimers Dement. 2007 Jul;3(3):186-91. doi: 10.1016/j.jalz.2007.04.381.

  PMID: 19595937 BACKGROUND

• Zlokovic BV. Neurovascular pathways to neurodegeneration in Alzheimer's disease and other disorders. Nat Rev Neurosci. 2011 Nov 3;12(12):723-38. doi: 10.1038/nrn3114.

  PMID: 22048062 BACKGROUND

• Liu B, Hong JS. Role of microglia in inflammation-mediated neurodegenerative diseases: mechanisms and strategies for therapeutic intervention. J Pharmacol Exp Ther. 2003 Jan;304(1):1-7. doi: 10.1124/jpet.102.035048.

  PMID: 12490568 BACKGROUND

• McGeer EG, McGeer PL. The role of the immune system in neurodegenerative disorders. Mov Disord. 1997 Nov;12(6):855-8. doi: 10.1002/mds.870120604. No abstract available.

  PMID: 9399206 BACKGROUND

• McGeer PL, Itagaki S, Tago H, McGeer EG. Reactive microglia in patients with senile dementia of the Alzheimer type are positive for the histocompatibility glycoprotein HLA-DR. Neurosci Lett. 1987 Aug 18;79(1-2):195-200. doi: 10.1016/0304-3940(87)90696-3.

  PMID: 3670729 BACKGROUND

• Galloway S, Jian L, Johnsen R, Chew S, Mamo JC. beta-amyloid or its precursor protein is found in epithelial cells of the small intestine and is stimulated by high-fat feeding. J Nutr Biochem. 2007 Apr;18(4):279-84. doi: 10.1016/j.jnutbio.2006.07.003. Epub 2006 Sep 7.

  PMID: 16962759 BACKGROUND

• Roher AE, Esh CL, Kokjohn TA, Castano EM, Van Vickle GD, Kalback WM, Patton RL, Luehrs DC, Daugs ID, Kuo YM, Emmerling MR, Soares H, Quinn JF, Kaye J, Connor DJ, Silverberg NB, Adler CH, Seward JD, Beach TG, Sabbagh MN. Amyloid beta peptides in human plasma and tissues and their significance for Alzheimer's disease. Alzheimers Dement. 2009 Jan;5(1):18-29. doi: 10.1016/j.jalz.2008.10.004.

  PMID: 19118806 BACKGROUND

• Smith D, Watts GF, Dane-Stewart C, Mamo JC. Post-prandial chylomicron response may be predicted by a single measurement of plasma apolipoprotein B48 in the fasting state. Eur J Clin Invest. 1999 Mar;29(3):204-9. doi: 10.1046/j.1365-2362.1999.00431.x.

  PMID: 10202376 BACKGROUND

• Kivipelto M, Helkala EL, Laakso MP, Hanninen T, Hallikainen M, Alhainen K, Soininen H, Tuomilehto J, Nissinen A. Midlife vascular risk factors and Alzheimer's disease in later life: longitudinal, population based study. BMJ. 2001 Jun 16;322(7300):1447-51. doi: 10.1136/bmj.322.7300.1447.

  PMID: 11408299 BACKGROUND

• Pallebage-Gamarallage MM, Lam V, Takechi R, Galloway S, Mamo JC. A diet enriched in docosahexanoic Acid exacerbates brain parenchymal extravasation of apo B lipoproteins induced by chronic ingestion of saturated fats. Int J Vasc Med. 2012;2012:647689. doi: 10.1155/2012/647689. Epub 2011 Nov 10.

  PMID: 22121489 BACKGROUND

• Grant WB. Dietary links to Alzheimer's disease: 1999 update. J Alzheimers Dis. 1999 Nov;1(4-5):197-201. doi: 10.3233/jad-1999-14-501.

  PMID: 12214118 BACKGROUND

• Kalmijn S, Launer LJ, Ott A, Witteman JC, Hofman A, Breteler MM. Dietary fat intake and the risk of incident dementia in the Rotterdam Study. Ann Neurol. 1997 Nov;42(5):776-82. doi: 10.1002/ana.410420514.

  PMID: 9392577 BACKGROUND

• Morris MC, Evans DA, Bienias JL, Tangney CC, Bennett DA, Aggarwal N, Schneider J, Wilson RS. Dietary fats and the risk of incident Alzheimer disease. Arch Neurol. 2003 Feb;60(2):194-200. doi: 10.1001/archneur.60.2.194.

  PMID: 12580703 BACKGROUND

• Castellano JM, Garcia-Rodriguez S, Espinosa JM, Millan-Linares MC, Rada M, Perona JS. Oleanolic Acid Exerts a Neuroprotective Effect Against Microglial Cell Activation by Modulating Cytokine Release and Antioxidant Defense Systems. Biomolecules. 2019 Nov 1;9(11):683. doi: 10.3390/biom9110683.

  PMID: 31683841 BACKGROUND

• Espinosa JM, Castellano JM, Garcia-Rodriguez S, Quintero-Florez A, Carrasquilla N, Perona JS. Lipophilic Bioactive Compounds Transported in Triglyceride-Rich Lipoproteins Modulate Microglial Inflammatory Response. Int J Mol Sci. 2022 Jul 12;23(14):7706. doi: 10.3390/ijms23147706.

  PMID: 35887052 BACKGROUND

• Espinosa JM, Quintero-Florez A, Carrasquilla N, Montero E, Rodriguez-Rodriguez A, Castellano JM, Perona JS. Bioactive compounds in pomace olive oil modulate the inflammatory response elicited by postprandial triglyceride-rich lipoproteins in BV-2 cells. Food Funct. 2023 Oct 2;14(19):8987-8999. doi: 10.1039/d3fo02460a.

  PMID: 37740318 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease; Inflammation

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 7, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)