Fatty Acid Diets for Aging

Overseen By Jenna Makarewicz, B.S.

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Vermont

Must not be taking: Antipsychotics, Anxiolytics, Sedatives

Disqualifiers: Diabetes, Heart failure, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different types of fatty acids in diets affect brain function in healthy adults aged 65-75. Participants will follow two experimental diets: one high in palmitic acid, common in North American diets, and another high in oleic acid, found in Mediterranean diets (also known as the High Oleic Acid Diet). Each diet lasts for one week, with a balanced low-fat diet in between. Eligible participants are those with normal mental function who are generally healthy and do not have serious health conditions or dietary restrictions. As an unphased trial, this study allows participants to contribute to valuable research on diet and brain health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on certain medications for cognitive or behavioral issues, hormone replacement therapy, or treatments for certain health conditions like Type 2 Diabetes (unless it's metformin).

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the High Oleic Acid (HOA) diet often links to good health. Studies indicate that diets rich in oleic acid, a key component of the Mediterranean diet, can lower inflammation markers like Interleukin-6 (IL-6). This suggests the HOA diet could benefit overall health and well-being.

In contrast, the High Palmitic Acid (HPA) diet has shown mixed results. Some studies suggest that reducing palmitic acid can improve brain function and decrease inflammation in older adults. However, diets high in palmitic acid have been linked to increased levels of certain proteins associated with brain changes.

Both diets have been studied in healthy older adults, and no serious safety concerns have been reported. However, the HOA diet generally links to better health outcomes compared to the HPA diet. While both diets are considered safe, the HOA diet might offer more health benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Fatty Acid Diets for Aging trial because it's exploring how different types of fats in our diets might impact aging. Unlike traditional dietary recommendations that often focus on calorie counting or macronutrient ratios, this trial specifically examines the effects of consuming high oleic acid, a monounsaturated fat prevalent in the Mediterranean diet, and high palmitic acid, a saturated fat common in the American diet. These diets could offer new insights into how specific fats influence aging processes, potentially leading to more tailored dietary guidelines that promote healthier aging. The trial could reveal whether the Mediterranean diet's heart-healthy fats offer distinct benefits over typical saturated fats found in many processed foods.

What evidence suggests that this trial's diets could be effective for brain functioning in aging adults?

This trial will compare the effects of two different diets on aging: the High Oleic Acid Diet (HOA) and the High Palmitic Acid Diet (HPA). Research has shown that the Mediterranean diet, similar to the HOA diet, is high in oleic acid and links to better health. Studies indicate that people who closely follow this diet tend to live longer and have a lower risk of heart disease. Olive oil, a main source of oleic acid, is known for its anti-inflammatory properties and cell protection, which may contribute to longevity.

In contrast, the HPA diet, similar to diets high in palmitic acid often found in the North American diet, can negatively affect brain function and increase inflammation. Research suggests that reducing palmitic acid intake can decrease inflammation and improve brain function in older adults. Overall, the Mediterranean diet, rich in oleic acid, offers promising benefits for aging and brain health. ^{1 4 6 7 8}

Who Is on the Research Team?

JUlie A Dumas, Ph.D.

Principal Investigator

University of Vermont

Craig L Kien, MD, PhD

Principal Investigator

University of Vermont

Are You a Good Fit for This Trial?

This trial is for healthy older adults aged 65-75 who want to participate in a study on how different fats in the diet affect brain function. Participants will follow strict diets provided by the research team and be closely monitored.

Inclusion Criteria

My BMI is between 20 and 40.

Normal cognition (see Research Strategy for details on cognitive assessments)

I am between 65 and 75 years old.

Exclusion Criteria

Hyper-androgenic condition

I am not on medication for significant cognitive or behavioral issues.

I have Type 2 Diabetes and am treated with drugs other than metformin.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Control Diet

Participants follow a low-fat control diet to balance monounsaturated and saturated fatty acids

2 weeks

2 visits (in-person)

Experimental Diets

Participants follow two experimental diets in a random order: one with a high PA/OA ratio and one with a low PA/OA ratio

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for changes in working memory performance and brain activation

1 week

What Are the Treatments Tested in This Trial?

Interventions

• High Oleic Acid Diet
• High Palmitic Acid Diet

Trial Overview

The study tests two diets: one high in palmitic acid, like a typical North American diet, and another high in oleic acid, similar to the Mediterranean Diet. Each participant tries both for one week with a low-fat control diet before each test period.

How Is the Trial Designed?

Group I: High Palmitic Acid Diet (HPA) Experimental Treatment 1 Intervention

Participants will ingest the HPA diet for one week. The saturated fatty acid will be high in palmitic acid which is the most prevalent saturated fatty acid in the American diet. The HPA diet will be proceeded by a one week controlled diet were the fat content is balanced between monounsaturated and saturated fatty acids.

Group II: High Oleic Acid/Low Palmitic Acid Diet (HOA) Experimental Treatment 1 Intervention

Participants will ingest the HOA diet for one week. The monounsaturated fatty acid will be high in oleic acid which is the most prevalent monounsaturated fatty acid in the Mediterranean diet. The HOA diet will be proceeded by a one week controlled diet were the fat content is balanced between monounsaturated and saturated fatty acids.

Who Is Running the Clinical Trial?

University of Vermont

Lead Sponsor

Trials

283

Recruited

3,747,000+

Published Research Related to This Trial

A study of 200 hospitalized patients over 60 years old revealed that 91.5% had unhealthy diets, which were linked to poor clinical outcomes like malnutrition and frailty.

Higher adherence to the Mediterranean diet was associated with shorter hospital stays and better overall health, indicating that improving dietary habits could enhance recovery in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to the Mediterranean diet in Turkish hospitalized older adults and its association with hospital clinical outcomes. Ergul, F., Sackan, F., Koc, A., et al.[2022]

The European Food Safety Authority has set a Tolerable Daily Intake (TDI) for erucic acid at 7 mg per kg of body weight, but this assessment did not fully account for erucic acid levels in fish and seafood.

Data from the Institute of Marine Research in Norway indicate that consuming a 200 g meal of mackerel could exceed the TDI for erucic acid, contributing up to 143% of the TDI for a 60 kg person, highlighting potential health risks associated with high consumption of certain fish.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Erucic Acid (22:1n-9) in Fish Feed, Farmed, and Wild Fish and Seafood Products. Sissener, NH., Ørnsrud, R., Sanden, M., et al.[2019]

In a study of 60 elderly individuals, those who adhered more closely to the Mediterranean diet (MD) had lower waist-hip ratios and body fat percentages, indicating better nutritional status and potentially lower health risks.

Low adherence to the MD was associated with higher rates of obesity, increased consumption of tobacco and alcohol, and greater cardiovascular risk, highlighting the importance of diet in overall health for the elderly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adherence to the Mediterranean diet and its relation to nutritional status in older people]. Zaragoza Martí, A., Ferrer Cascales, R., Cabañero Martínez, MJ., et al.[2016]

Adopting a Mediterranean diet, which includes fresh fruits, vegetables, fish, and moderate wine consumption, is recommended for all ages and can significantly improve health behaviors during retirement.

The HALE project demonstrated that controlling lifestyle factors such as diet, physical activity, and non-smoking can reduce overall mortality by 65%, highlighting the importance of a holistic approach to health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Eating and drinking during aging]. Imoberdorf, R., Rühlin, M., Ballmer, PE.[2016]

A comprehensive review of 90 randomized controlled trials found that omega-3 polyunsaturated fatty acids (PUFAs) are associated with a higher likelihood of certain adverse effects, including diarrhea, dysgeusia (altered taste), and bleeding tendency, compared to placebo.

Despite these adverse effects, there were no serious adverse events reported related to omega-3 PUFA supplementation, suggesting that while they may cause some minor issues, they are generally safe and tolerable for most individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Supplementation of Omega-3 Polyunsaturated Fatty Acids: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Chang, JP., Tseng, PT., Zeng, BS., et al.[2023]

Replacing traditional soybean and canola oils with high-oleic varieties can lead to increased intake of monounsaturated fatty acids (MUFAs) while decreasing saturated fatty acids (SFAs) and polyunsaturated fatty acids (PUFAs), including essential fatty acids (EFAs) like α-linolenic acid (ALA) and linoleic acid (LA).

Modeling scenarios suggest that replacing 25-50% of traditional oils with high-oleic oils may put certain adult age and sex groups at risk of not meeting the Adequate Intake levels for LA and ALA, highlighting a potential nutritional concern.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modeled replacement of traditional soybean and canola oil with high-oleic varieties increases monounsaturated fatty acid and reduces both saturated fatty acid and polyunsaturated fatty acid intake in the US adult population. Raatz, SK., Conrad, Z., Jahns, L., et al.[2023]

Diets enriched in oleic acid (OA) have been shown to positively influence body weight management and reduce abdominal fat, based on a systematic review of 28 clinical trials.

Mechanistically, OA may help regulate energy balance and food intake through pathways like AMP-activated protein kinase signaling, suggesting that including OA-rich foods in the diet can support healthy weight maintenance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Diets Enriched in Monounsaturated Oleic Acid on the Management and Prevention of Obesity: a Systematic Review of Human Intervention Studies. Tutunchi, H., Ostadrahimi, A., Saghafi-Asl, M.[2023]

A study analyzing dietary data from 7814 children aged 1-8 years found that replacing 40% or more of traditional vegetable oils with high-oleic acid oils could lead to inadequate intake of essential fatty acids (EFAs), which are crucial for growth and development.

The main sources of EFAs in children's diets were identified as grain dishes, meat and seafood, and fruit and vegetable dishes, highlighting the need for a balanced approach that includes both traditional and high-oleic oils to ensure children meet their daily EFA requirements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modeled Substitution of Traditional Oils with High-Oleic Acid Oils Decreases Essential Fatty Acid Intake in Children. Belury, MA., Raatz, S., Conrad, Z.[2023]

A study on individuals over 70 years old found that following the traditional Greek variant of the Mediterranean diet is linked to a significant 17% reduction in overall mortality for each unit increase in dietary adherence score.

This suggests that a closer adherence to this diet can positively impact life expectancy in elderly populations, highlighting the potential health benefits of traditional dietary patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survival beyond age 70 in relation to diet. de Groot, LC., van Staveren, WA., Burema, J.[2019]

In a study of 2671 elderly participants with a history of myocardial infarction, adherence to a modified Mediterranean diet was linked to an 18% reduction in overall mortality over a median follow-up of 6.7 years.

The findings suggest that a modified Mediterranean diet, which is easier for Western populations to adopt, can significantly improve survival rates among coronary patients, although the effect was less pronounced in northern Europeans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modified Mediterranean diet and survival after myocardial infarction: the EPIC-Elderly study. Trichopoulou, A., Bamia, C., Norat, T., et al.[2021]

In a study of 278 elderly participants over 8.5 years, higher intake of monounsaturated fatty acids (MUFA) was linked to increased survival rates, suggesting a protective effect against all-cause mortality.

While a higher ratio of unsaturated fatty acids (UFA) to saturated fatty acids (SFA) showed a slight increase in total mortality, the effect was marginal, indicating that MUFA may be more beneficial for longevity in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unsaturated fatty acids intake and all-causes mortality: a 8.5-year follow-up of the Italian Longitudinal Study on Aging. Solfrizzi, V., D'Introno, A., Colacicco, AM., et al.[2006]

In a study involving 32 elderly patients over 6 months, an enteral diet enriched with n-3 polyunsaturated fatty acids (EPA and DHA) improved their plasma lipid profiles and significantly lowered triglyceride levels, a key cardiovascular risk factor.

The enriched diet did not show any major changes in insulin resistance or related biomarkers, indicating that while it benefits cardiovascular health, it does not negatively impact metabolic health in elderly patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of an eicosapentaenoic and docosahexaenoic acid-enriched enteral nutrition formula on plasma fatty acid composition and biomarkers of insulin resistance in the elderly. Olza, J., Mesa, MD., Aguilera, CM., et al.[2015]

A study involving 69 women aged 25 to 59 showed that a Greek-Mediterranean diet significantly increased dietary monounsaturated fat intake by 48% while maintaining total fat levels, indicating effective dietary modification.

Participants also increased their fruit and vegetable consumption from an average of 4.0 to 8.6 servings per day, demonstrating the diet's potential for promoting healthier eating habits in breast cancer prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of a Mediterranean exchange list diet implemented by telephone counseling. Djuric, Z., Vanloon, G., Radakovich, K., et al.[2021]

Omega-3 fatty acids are recognized as potentially important nutrients that may help prevent health issues associated with aging, particularly in older adults aged 65 and above.

Despite the growing elderly population, the review found a lack of sufficient evidence from studies (36 included out of 685 citations) to definitively conclude the effects of omega-3 fatty acids on aging metabolism and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omega 3 fatty acids in the elderly. Ubeda, N., Achón, M., Varela-Moreiras, G.[2012]

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