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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to determine the effect of elevated plasma ceramides on peripheral vascular function. Subjects will consume a high fat meal consisting of long chain fatty acids (to increase plasma ceramides) or medium chain fatty acids (control). Subjects' vascular function will be assessed with laser Doppler flowmetry to measure their artery function and with the CytoCam device to assess their peripheral microvascular endothelial function.

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 a high saturated fat diet safe for humans?

Research suggests that high intake of saturated fats is linked to an increased risk of heart disease and other health issues. Studies recommend replacing saturated fats with healthier unsaturated fats to lower the risk of cardiovascular disease. ^{1 2 3 4 5}

How does a high saturated fat diet treatment differ from other treatments for peripheral vascular disease?

A high saturated fat diet treatment is unique because it focuses on dietary intake rather than medication or lifestyle changes, which are common in managing peripheral vascular disease. This approach contrasts with other treatments that often emphasize reducing saturated fat and cholesterol intake to lower disease risk. ^{6 7 8 9 10}

Eligibility Criteria

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.

I speak English.

Exclusion Criteria

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

Pregnant individuals

I have heart failure.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Saturated fatty acids and mortality in patients referred for coronary angiography-The Ludwigshafen Risk and Cardiovascular Health study. [2019]

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

Dietary Fats and Cardiovascular Disease: A Presidential Advisory From the American Heart Association. [2022]

3. England 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. [2022]

4. England pubmed.ncbi.nlm.nih.gov

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

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

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

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

Diet and peripheral arterial occlusive disease: the role of poly-, mono-, and saturated fatty acids. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Dietary patterns, plasma vitamins and Trans fatty acids are associated with peripheral artery disease. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Intake of marine n-3 polyunsaturated fatty acids and the risk of incident peripheral artery disease. [2023]

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

Dietary intake of participants with peripheral artery disease and claudication. [2021]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of lifestyle modification and lipid intake variations on patients with peripheral vascular disease. [2019]