High Saturated Fat Diet for Peripheral Vascular Disease

Overseen By Shona Hang, MSPH

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Disqualifiers: Diabetes, Coronary artery disease, Hypertension, High cholesterol, Heart failure, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a high saturated fat diet affects blood circulation in individuals with peripheral vascular disease, a condition that reduces blood flow to the limbs. Participants will consume meals containing either long-chain fatty acids (a type of high saturated fat) or medium-chain fatty acids to assess their impact on blood vessel function. The trial aims to determine if different dietary fats can alter blood flow through small vessels. Suitable candidates for the trial are healthy adults without heart disease, diabetes, or high blood pressure, and who do not use tobacco. As an unphased trial, this study offers participants the opportunity to contribute to groundbreaking research on dietary fats and vascular health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have conditions like high blood pressure, high cholesterol, or heart disease, you may not be eligible to participate.

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

Research has shown that consuming large amounts of saturated fats, such as those in butter, cheese, and some meats, can increase LDL cholesterol, often referred to as "bad" cholesterol. This increase can elevate the risk of heart and blood vessel issues. Some studies suggest that replacing saturated fats with healthier fats might significantly lower this risk.

For the high saturated fat treatment under study in the trial, specific safety information is not yet available. The trial's "Not Applicable" phase focuses on basic research rather than safety testing. This phase typically indicates that the treatment's safety has not been evaluated in this context.

While the trial may provide new insights, current research still raises concerns about the safety of consuming high levels of saturated fats. Consulting a healthcare provider before deciding to join such a study is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using high saturated fat meals to explore peripheral vascular disease treatment because these meals focus on the effect of increased plasma ceramide, a unique approach compared to traditional treatments like medications or lifestyle changes that target overall cholesterol levels. The trial examines two types of high fat meals: medium chain fatty acid and long chain fatty acid meals, each with distinct impacts on microvascular function. This investigation could reveal new insights into how specific dietary fats influence vascular health, potentially leading to innovative dietary-based management strategies for peripheral vascular disease.

What evidence suggests that this trial's treatments could be effective for peripheral vascular disease?

Research shows that consuming a lot of saturated fats links to a higher risk of heart disease. Saturated fats can increase bad cholesterol, which may block arteries. Studies have found that replacing saturated fats with healthier fats, like polyunsaturated fats, can reduce the risk of heart disease by about 30%. Some sources of saturated fats, such as those from dairy, might pose slightly less risk than others. This trial will compare the effects of different types of high-fat meals on peripheral microvascular function. One arm will assess the impact of a medium-chain fatty acid high-fat meal, while another will focus on a long-chain fatty acid high-fat meal. The ongoing research examines how increased levels of ceramides (a type of fat) from these meals affect blood flow in small blood vessels. Although the full effects are still under study, current evidence suggests caution with high saturated fat intake. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for healthy, English-speaking adults aged 18-40 who are not pregnant. It's not suitable for those with blood pressure or heart rate outside of normal ranges, current tobacco users, lactose intolerant individuals, anyone with open mouth sores or wounds, diabetes patients, people with coronary artery disease or high cholesterol, recent chemotherapy patients, and non-English speakers.

Inclusion Criteria

Not pregnant

I am a healthy adult between 18 and 40 years old.

Exclusion Criteria

I am under 18 or over 40 years old and healthy.

Pregnant individuals

I have heart failure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume a high fat meal consisting of long chain or medium chain fatty acids to assess vascular function

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• High Saturated Fat

Trial Overview The study aims to see how a high fat meal affects the peripheral vascular function in participants. They will eat meals rich in long chain fatty acids (which may increase plasma ceramides) versus medium chain fatty acids (control). Their artery function and microvascular endothelial function will be measured using laser Doppler flowmetry and the CytoCam device.

How Is the Trial Designed?

Group I: Long Chain Fatty Acid High Fat Meal Experimental Treatment 1 Intervention

This arm will assess the effect of increased plasma ceramide on peripheral microvascular function after consuming a long chain fatty acid high fat meal.

Group II: Medium Chain Fatty Acid High Fat Meal Active Control 1 Intervention

This arm will assess the effect of increased plasma ceramide on peripheral microvascular function after consuming a medium chain fatty acid high fat meal.

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Published Research Related to This Trial

Diets low in long chain saturated fatty acids and high in linoleic acid are linked to a reduced risk of coronary heart disease (CHD), supported by both human studies and animal experiments.

These diets may lower atherosclerosis and arterial thrombosis by affecting platelet aggregation and vascular functions, although the exact mechanisms are still being researched.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary prevention of coronary heart disease. Effect of dietary fats on arterial thrombosis. Hornstra, G.[2019]

In a study of 3,259 patients undergoing coronary angiography, higher levels of palmitic acid (a type of saturated fatty acid) in red blood cells were linked to an increased risk of total and cardiovascular mortality over a median follow-up of 9.9 years.

Other saturated fatty acids did not show any significant association with mortality, highlighting the importance of evaluating individual fatty acids rather than treating them as a group when assessing health risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Saturated fatty acids and mortality in patients referred for coronary angiography-The Ludwigshafen Risk and Cardiovascular Health study. Kleber, ME., Delgado, GE., Dawczynski, C., et al.[2019]

A case-control study of 200 patients (100 with peripheral arterial occlusive disease and 100 controls) found that high intakes of saturated fatty acids, proteins, and dietary cholesterol significantly increased the risk of developing the disease, with odds ratios indicating a strong association.

Conversely, higher intakes of polyunsaturated fatty acids and crude fiber were linked to a reduced risk of the disease, suggesting that a diet rich in these nutrients, along with fiber and vitamin C, may help protect against peripheral arterial occlusive disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet and peripheral arterial occlusive disease: the role of poly-, mono-, and saturated fatty acids. Katsouyanni, K., Skalkidis, Y., Petridou, E., et al.[2019]

In a study of 4864 participants, those with a diet high in trans fatty acids (TFA) had significantly higher odds of developing peripheral artery disease (PAD), with an odds ratio of 6.43 for the highest quartile of TFA consumption compared to the lowest.

Conversely, participants with diets rich in vitamins and polyunsaturated fatty acids showed lower odds of PAD, suggesting that improving dietary quality could be a potential strategy for preventing or delaying the progression of this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary patterns, plasma vitamins and Trans fatty acids are associated with peripheral artery disease. Mazidi, M., Wong, ND., Katsiki, N., et al.[2022]

In a study involving 55,248 participants over a median follow-up of 13.6 years, no significant association was found between the intake of marine n-3 polyunsaturated fatty acids (EPA, DHA, or their combination) and the risk of developing peripheral artery disease (PAD).

Despite previous hypotheses suggesting that higher intake of these fatty acids could lower PAD risk, the results indicate that dietary intake of EPA and DHA does not appear to influence the incidence of this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intake of marine n-3 polyunsaturated fatty acids and the risk of incident peripheral artery disease. Tram, L., Bork, CS., Venø, SK., et al.[2023]

A 15-month study with 24 male patients with peripheral vascular disease showed that a diet enriched with olive oil and fish oil, combined with lifestyle changes, significantly improved physical performance and reduced symptoms of claudication.

The intervention led to a notable decrease in LDL cholesterol levels and encouraged healthier habits, such as increased physical activity and reduced smoking, highlighting the effectiveness of dietary and lifestyle modifications in managing peripheral vascular disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of lifestyle modification and lipid intake variations on patients with peripheral vascular disease. Nestares, T., López-Jurado, M., Urbano, G., et al.[2019]

Saturated fat intake does not show a significant association with all-cause mortality, cardiovascular disease (CVD), coronary heart disease (CHD), ischemic stroke, or type 2 diabetes, based on a systematic review of studies involving up to 339,090 participants.

In contrast, trans fat intake is linked to increased risks of all-cause mortality, CHD mortality, and total CHD, particularly due to higher levels of industrial trans fats, indicating a need for careful dietary guidelines regarding these fats.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intake of saturated and trans unsaturated fatty acids and risk of all cause mortality, cardiovascular disease, and type 2 diabetes: systematic review and meta-analysis of observational studies. de Souza, RJ., Mente, A., Maroleanu, A., et al.[2022]

Recent analyses challenge the traditional 'lipid hypothesis' that solely blames saturated fats for increasing cardiovascular disease (CVD) risk, suggesting a more nuanced understanding is needed.

Current assessments should consider the overall dietary patterns and the types of macronutrients replacing saturated fats, rather than focusing only on saturated fat intake, for a healthier diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Saturated Fats and Cardiovascular Disease: Interpretations Not as Simple as They Once Were. Bier, DM.[2019]

Reducing dietary saturated fat and replacing it with polyunsaturated fats can lower the risk of cardiovascular disease (CVD) by approximately 30%, similar to the effects of statin medications, based on randomized controlled trials.

Replacing saturated fats with refined carbohydrates does not reduce CVD risk, highlighting the importance of choosing healthier fat sources, such as unsaturated fats, as part of a balanced diet like the DASH or Mediterranean diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Fats and Cardiovascular Disease: A Presidential Advisory From the American Heart Association. Sacks, FM., Lichtenstein, AH., Wu, JHY., et al.[2022]

Participants with peripheral artery disease (PAD) and claudication showed poor dietary habits, with none meeting sodium and vitamin E intake recommendations, and only a small percentage meeting fiber and folate guidelines.

The study highlights the need for dietary improvements among PAD patients, specifically reducing saturated fat, sodium, and cholesterol while increasing fiber and vitamin intake to align with National Cholesterol Education Program (NCEP) and Institute of Medicine (IOM) recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary intake of participants with peripheral artery disease and claudication. Gardner, AW., Bright, BC., Ort, KA., et al.[2021]

Citations

1. withpower.com withpower.com/trial/phase-vascular-diseases-5-2022-5d37c

High Saturated Fat Diet for Peripheral Vascular Disease Reducing dietary saturated fat and replacing it with polyunsaturated fats can lower the risk of cardiovascular disease (CVD) by approximately 30%, similar to ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2824150/

Saturated fat, carbohydrate, and cardiovascular disease1 Saturated fat intake has been linked to an increased risk of cardiovascular disease (CVD), and this effect is thought to be mediated primarily by increased ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5492032/

Saturated Fatty Acids and Cardiovascular Disease Replacing SFA with protein, especially plant protein, may also reduce CVD risk. While dairy fat (milk, cheese) is associated with a slightly lower CVD risk ...

4. ahajournals.org ahajournals.org/doi/10.1161/cir.0000000000000510

Dietary Fats and Cardiovascular Disease: A Presidential ... The high polyunsaturated, low saturated fat group experienced significantly fewer CVD events, 8 of 51 versus 24 of 51, a 67% reduction, much ...

5. academic.oup.com academic.oup.com/eurjpc/article/32/3/233/7810960

Association of circulating fatty acids with cardiovascular ... Associations of saturated and unsaturated fatty acids (FAs) with cardiovascular disease (CVD) remain controversial. We therefore aimed to investigate the ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK570127/

The Effect of Diet on Cardiovascular Disease and Lipid ... - NCBI Dietary saturated fatty acids (SFA), which are in milk, butter, cheese, beef, lamb, pork, poultry, palm oil, and coconut oil increase LDL-C and HDL-C.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34649831/

Saturated fats and cardiovascular health: Current evidence ... A diet high in saturated fatty acids (SFA) is a suspected contributor to atherosclerotic cardiovascular disease (ASCVD) risk.

8. mdpi.com mdpi.com/2072-6643/15/1/30

Saturated Fatty Acid Chain Length and Risk of ... The purpose of this systematic review was to evaluate the impact of saturated fatty acid chain lengths on the development of cardiovascular disease (CVD).