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

Trial Summary

What is the purpose of this trial?

In this crossover study, the investigtors will administer two experimental diets in a random order for one week, and each experimental diet will be preceded by a one-week, low fat control diet for a total four-week study period. The goal is to study how the fatty acid content of the diet affects brain functioning in healthy adults aged 65-75 years. One experimental diet will have a high palmitic acid (PA)/oleic acid (OA) ratio (HPA), typical of the North American diet. The other experimental diet will have a low PA/OA ratio (HOA), typical of the Mediterranean Diet. All allowed food and drink (except water) will be provided by the investigative team, and compliance will be enhanced by constant, intense dietary surveillance by a registered dietitian.

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).

What data supports the effectiveness of the Mediterranean Diet treatment for aging?

Research shows that following a Mediterranean diet, which is high in healthy fats like olive oil and rich in fruits and vegetables, is linked to a longer life and better health outcomes in older adults. Studies found that closer adherence to this diet can reduce overall mortality and improve survival rates, especially in those with heart conditions. ^{1 2 3 4 5}

Is the High Oleic Acid Diet safe for humans?

High-oleic acid oils, which are part of the High Oleic Acid Diet, are generally considered safe and are being used to replace less healthy fats in food production. However, replacing traditional oils with high-oleic acid oils may reduce essential fatty acid intake, which is important for growth and development, especially in children. ^{6 7 8 9 10}

How does the fatty acid diet treatment for aging differ from other treatments?

The fatty acid diet treatment for aging is unique because it focuses on increasing the intake of monounsaturated and polyunsaturated fatty acids, which have been shown to improve longevity and reduce mortality in older adults. Unlike other treatments, this approach emphasizes dietary changes, particularly the Mediterranean diet, which includes foods like olive oil, fish, and legumes, known for their health benefits in aging populations. ^{2 11 12 13 14}

Research Team

JUlie A Dumas, Ph.D.

Principal Investigator

University of Vermont

Craig L Kien, MD, PhD

Principal Investigator

University of Vermont

Eligibility Criteria

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.

I am between 65 and 75 years old.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Adherence to the Mediterranean diet in Turkish hospitalized older adults and its association with hospital clinical outcomes. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Survival beyond age 70 in relation to diet. [2019]

3. Spain pubmed.ncbi.nlm.nih.gov

[Adherence to the Mediterranean diet and its relation to nutritional status in older people]. [2016]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Modified Mediterranean diet and survival after myocardial infarction: the EPIC-Elderly study. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Design of a Mediterranean exchange list diet implemented by telephone counseling. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Erucic Acid (22:1n-9) in Fish Feed, Farmed, and Wild Fish and Seafood Products. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Safety of Supplementation of Omega-3 Polyunsaturated Fatty Acids: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Modeled Substitution of Traditional Oils with High-Oleic Acid Oils Decreases Essential Fatty Acid Intake in Children. [2023]

9. United States 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. [2023]

10. United States 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. [2023]

11. Switzerland pubmed.ncbi.nlm.nih.gov

[Eating and drinking during aging]. [2016]

12. England pubmed.ncbi.nlm.nih.gov

Omega 3 fatty acids in the elderly. [2012]

13. England 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. [2006]

14. England 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. [2015]