High Saturated Fat Diet for Peripheral Vascular Disease
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Medical College of Wisconsin
Disqualifiers: Diabetes, Coronary artery disease, Hypertension, High cholesterol, Heart failure, others
No Placebo Group
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.
12345How 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.
678910Eligibility 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.
+11 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Long Chain Fatty Acid High Fat MealExperimental Treatment1 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 MealActive Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Froedtert HospitalWauwatosa, WI
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Who Is Running the Clinical Trial?
Medical College of WisconsinLead Sponsor
References
Saturated fatty acids and mortality in patients referred for coronary angiography-The Ludwigshafen Risk and Cardiovascular Health study. [2019]Saturated fatty acids are thought to be harmful by increasing the risk for cardiovascular events.
Dietary Fats and Cardiovascular Disease: A Presidential Advisory From the American Heart Association. [2022]Cardiovascular disease (CVD) is the leading global cause of death, accounting for 17.3 million deaths per year. Preventive treatment that reduces CVD by even a small percentage can substantially reduce, nationally and globally, the number of people who develop CVD and the costs of caring for them. This American Heart Association presidential advisory on dietary fats and CVD reviews and discusses the scientific evidence, including the most recent studies, on the effects of dietary saturated fat intake and its replacement by other types of fats and carbohydrates on CVD. In summary, randomized controlled trials that lowered intake of dietary saturated fat and replaced it with polyunsaturated vegetable oil reduced CVD by ≈30%, similar to the reduction achieved by statin treatment. Prospective observational studies in many populations showed that lower intake of saturated fat coupled with higher intake of polyunsaturated and monounsaturated fat is associated with lower rates of CVD and of other major causes of death and all-cause mortality. In contrast, replacement of saturated fat with mostly refined carbohydrates and sugars is not associated with lower rates of CVD and did not reduce CVD in clinical trials. Replacement of saturated with unsaturated fats lowers low-density lipoprotein cholesterol, a cause of atherosclerosis, linking biological evidence with incidence of CVD in populations and in clinical trials. Taking into consideration the totality of the scientific evidence, satisfying rigorous criteria for causality, we conclude strongly that lowering intake of saturated fat and replacing it with unsaturated fats, especially polyunsaturated fats, will lower the incidence of CVD. This recommended shift from saturated to unsaturated fats should occur simultaneously in an overall healthful dietary pattern such as DASH (Dietary Approaches to Stop Hypertension) or the Mediterranean diet as emphasized by the 2013 American Heart Association/American College of Cardiology lifestyle guidelines and the 2015 to 2020 Dietary Guidelines for Americans.
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]To systematically review associations between intake of saturated fat and trans unsaturated fat and all cause mortality, cardiovascular disease (CVD) and associated mortality, coronary heart disease (CHD) and associated mortality, ischemic stroke, and type 2 diabetes.
Dietary prevention of coronary heart disease. Effect of dietary fats on arterial thrombosis. [2019]Epidemiological studies indicate that dietary saturated fats are implicated in coronary heart disease (CHD). Human prospective studies have shown that diets low in long chain saturated fatty acids and enriched in linoleic acid are beneficial in CHD-prevention. Experiments in animals have shown that such diets diminish atherosclerosis and the tendency to arterial thrombosis; they also lower the ability of platelets to aggregate in animals and in man. The mechanisms by which these diets produce these effects are not yet completely understood. Platelets and vascular prostaglandin-like substances may be involved as well as platelet membrane fluidity and platelet coagulant activities. On the basis of the available evidence, measures to decrease the intake of long chain saturated fatty acids (concomitant with an enhanced consumption of linoleic acid-rich products) are justified. Although certain marine oils may also have anti-thrombotic properties the possibility of undesirable side effects compels extensive investigation before their wide-spread use can be recommended.
Saturated Fats and Cardiovascular Disease: Interpretations Not as Simple as They Once Were. [2019]Historically, the so-called "lipid hypothesis" has focused on the detrimental role of saturated fats per se in enhancing the risks of cardiovascular disease. Recently, a body of new information and systematic analyses of available data have questioned simple interpretation of the relationship of dietary saturated fats and of individual saturated fatty acids to CVD risk. Thus, current assessments of risks due to dietary fat consumption that emphasize the confounding nature of the dietary macronutrients substituted for dietary saturated fats and give broader recognition to the effect of patterns of food intake as a whole are the most productive approach to an overall healthy diet.
Diet and peripheral arterial occlusive disease: the role of poly-, mono-, and saturated fatty acids. [2019]A case-control study concerning the association between diet and peripheral arterial occlusive disease was conducted in Athens, Greece. The case series consisted of 100 patients with this disease, whereas controls were 100 patients with conditions requiring minor surgical care who were admitted to the same teaching hospital. Diet was ascertained through a semiquantitative food frequency questionnaire. Nutrient intakes for individuals were estimated by multiplying the nutrient content of a selected typical portion size for each specified food item by the frequency that the food was used per month and summing these estimates for all food items. Data were analyzed using multiple logistic regression procedures, controlling for total energy intake by taking nutrient residuals and by using multivariate nutrient density models. Saturated fatty acids (odds ratio (OR) and 95% confidence interval (CI) contrasting the 75th centile (upper) with the 25th centile = 1.96 and 1.14-3.39), proteins (OR = 2.86, 95% CI 1.47-5.55), and dietary cholesterol (OR = 6.07, 95% CI 2.74-13.46) were associated with increased risk of peripheral arterial occlusive disease, whereas polyunsaturated fatty acids (OR = 0.48, 95% CI 0.24-0.93) and crude fiber (OR = 0.33, 95% CI 0.17-0.64) were related to reduced risk. Monounsaturated fatty acids and, by inference, olive oil occupy an intermediate neutral position between polyunsaturates and saturates (corresponding OR = 1.14, 95% CI 0.68-1.91). Higher intakes of fiber and vitamin C were associated with lower risk of peripheral arterial occlusive disease. The low occurrence of atherosclerotic diseases in Greece and other Mediterranean countries may be due to the substitution of olive oil in place of saturated fats and/or the consumption of a diet high in vegetables, fruits, and other fiber-containing foods.
Dietary patterns, plasma vitamins and Trans fatty acids are associated with peripheral artery disease. [2022]To investigate the association between dietary patterns (DP), plasma vitamins and trans fatty acids (TFAs) with the likelihood of peripheral artery disease (PAD).
Intake of marine n-3 polyunsaturated fatty acids and the risk of incident peripheral artery disease. [2023]A high intake of marine n-3 polyunsaturated fatty acids (PUFAs) may lower the risk of coronary heart disease and ischemic stroke. The association between intake of marine n-3 PUFAs and development of peripheral artery disease (PAD), however, remains unexplored. We hypothesised that intake of marine n-3 PUFAs, eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and the sum of EPA + DHA was associated with a lower risk of incident PAD.
Dietary intake of participants with peripheral artery disease and claudication. [2021]We compared the dietary intake of participants with peripheral artery disease (PAD) and claudication with diet recommendations of the National Cholesterol Education Program (NCEP) and dietary reference intake values recommended by the Institute of Medicine (IOM) of the National Academy of Sciences. Forty-six participants consumed a mean macronutrient composition of 17% protein, 51% carbohydrate, and 30% fat. Compared to the NCEP and IOM recommendations, few participants met the recommended daily intake for sodium (0%), vitamin E (0%), folate (13%), saturated fat (20%), fiber (26%), and cholesterol (39%). Participants with PAD and claudication have poor nutrition, with diets particularly high in saturated fat, sodium, and cholesterol, and low in fiber, vitamin E, and folate intakes. Participants should be encouraged to reduce consumption of dietary fat, saturated fat, cholesterol, and sodium and to increase fiber and vitamin intakes to meet recommendations of the NCEP and IOM.
Effects of lifestyle modification and lipid intake variations on patients with peripheral vascular disease. [2019]The aim of the present study was to evaluate the effects of diets enriched in monounsaturated fatty acids (MUFA) (olive oil) or MUFA plus n-3 polyunsaturated fatty acids (PUFA) (olive oil plus fish oil), associated with an intervention program that focused on lifestyle habits, physical performance, plasma lipids, and lipoprotein composition in patients with peripheral vascular disease (PVD). A 15-month longitudinal nutritional and lifestyle intervention study was carried out with 24 free-living male patients aged 58.0 +/- 2.2 years diagnosed with PVD (Fontaine grade II). The patients were clinically evaluated and counseled to change their dietary and lifestyle habits for six months, after this period they consumed an olive oil-based diet for three months: after a three-month wash-out period, their diet was supplemented with a combination of fish oil and olive oil for the final three months. Lifestyle interventions resulted in a significant decrease in cigarette smoking and an increase in physical activity. Claudicometry was lower at the end of the study than at the beginning. Intake of the fish oil supplement led to significant changes in lipid lipoprotein composition, decreasing low-density lipoprotein (LDL) cholesterol. The lifestyle intervention program, together with a high intake of olive plus fish oil, seems to produce important beneficial effects in nutritional management, physical performance, and clinical parameters of PVD patients.