40 Participants Needed

Ketogenic Diet for Cardiovascular Health

KS
SM
Overseen ByStacey Meily
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial requires that participants do not take anti-hypertensive, lipid-lowering, or glucose-lowering drugs. If you take supplements that affect the study's outcomes, you must be willing to stop them during the study period.

What data supports the effectiveness of the treatment Ketogenic Diet for cardiovascular health?

Research shows that low-carbohydrate diets, like the ketogenic diet, can lead to weight loss and improve some heart health markers, such as cholesterol and blood pressure, more effectively than low-fat diets. However, there are concerns about potential increases in cholesterol levels, so monitoring is important.12345

Is the ketogenic diet safe for cardiovascular health?

The ketogenic diet may raise concerns for cardiovascular health, as some studies report cases of heart issues like type 2 myocardial infarction and significant increases in cholesterol levels. Monitoring heart health and cholesterol is advised for those on this diet.23678

How does the ketogenic diet treatment for cardiovascular health differ from other treatments?

The ketogenic diet is unique because it focuses on high fat and low carbohydrate intake, which can improve heart health by enhancing cardiac energy use and reducing oxygen needs. Unlike traditional low-fat diets, it may also lead to better weight loss and cardiovascular risk reduction, although it can raise cholesterol levels and requires careful adherence.3891011

What is the purpose of this trial?

The goal of this clinical trial is to examine the effect of the ketogenic diet over four weeks on blood lipid levels and risk factors for heart disease in adults with a healthy BMI compared to adults with a body mass index (BMI) in the range for obesity. The main questions it aims to answer are:* Does the ketogenic diet cause larger increases in "bad cholesterol" (low density lipoprotein-cholesterol) in adults with a healthy BMI compared to adults with BMI in the range for obesity?* Does the ketogenic diet cause larger decreases in vascular health in adults with a healthy BMI compared to adults with BMI in the range for obesity?Participants will:* Consume all of the study food provided and avoid intake of non-study foods during the 28-day diet period* Visit the metabolic kitchen daily (Monday-Friday) to pick up meals* Attend 5 fasting visits at the Clinical Research Center for testing

Eligibility Criteria

This trial is for healthy adults who are either at a normal weight or have obesity, as determined by their BMI. They must be willing to follow a strict ketogenic diet provided by the study for four weeks and can commit to daily visits on weekdays to pick up meals and attend five fasting tests.

Inclusion Criteria

Fasting triglycerides <350 mg/dL
Fasting direct LDL-C ≤100 mg/dL
Fasting blood glucose <126 mg/dL
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Exclusion Criteria

I have taken oral steroids in the last month.
I have had weight loss surgery in the past.
Principal Investigator discretion related to the potential participant's ability to adhere to the study requirements including being able to come to the metabolic kitchen to pick-up food five days per week
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow a ketogenic diet for 28 days, with daily meal pickups and fasting visits for testing

4 weeks
5 fasting visits (in-person), daily meal pickups (Monday-Friday)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Ketogenic Diet
Trial Overview The study is testing how a ketogenic diet affects blood lipid levels and heart disease risk factors over four weeks in two groups of adults: those with a normal BMI versus those with an obese BMI. It aims to see if there's a difference in 'bad cholesterol' increase or vascular health decrease between these groups.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Low BMIExperimental Treatment1 Intervention
BMI 18.5 - 22 kg/m\^2 Intervention: Ketogenic diet 28 days
Group II: High BMIActive Control1 Intervention
BMI 30-35 kg/m\^2 Intervention: Ketogenic diet 28 days

Find a Clinic Near You

Who Is Running the Clinical Trial?

Penn State University

Lead Sponsor

Trials
380
Recruited
131,000+

Findings from Research

The Mediterranean diet is strongly supported by evidence showing significant reductions in mortality rates and heart attack occurrences, making it a highly recommended option for patients aiming to reduce cardiovascular disease risk.
While popular diets like Atkins and South Beach are effective for weight loss, they lack substantial evidence for long-term health benefits, highlighting the importance of focusing on patient-oriented outcomes in dietary counseling.
Diets for cardiovascular disease prevention: what is the evidence?Walker, C., Reamy, BV.[2022]
The ketogenic diet (KD) can lead to significant increases in total cholesterol and low-density lipoprotein (LDL) cholesterol, especially in lean individuals, highlighting the need for careful lipid monitoring during the diet.
Improvements in cholesterol levels were observed after discontinuing the KD, suggesting that while the diet may aid in weight loss and glycemic control, it can have adverse effects on lipid profiles that need to be managed.
Profound Elevation in LDL Cholesterol Level Following a Ketogenic Diet: A Case Series.Crosier, R., McPherson, R.[2022]
Low-carbohydrate/high-protein diets were found to be more effective than low-fat/high-carbohydrate diets for weight loss and improving cardiovascular risk factors, based on a systematic review of 13 randomized controlled trials lasting at least 6 months.
Participants showed a preference for low-carbohydrate diets, as indicated by a higher dropout rate in the low-fat diet group, suggesting that these diets may be more sustainable for long-term weight management.
Systematic review of randomized controlled trials of low-carbohydrate vs. low-fat/low-calorie diets in the management of obesity and its comorbidities.Hession, M., Rolland, C., Kulkarni, U., et al.[2022]

References

Diets for cardiovascular disease prevention: what is the evidence? [2022]
Profound Elevation in LDL Cholesterol Level Following a Ketogenic Diet: A Case Series. [2022]
Systematic review of randomized controlled trials of low-carbohydrate vs. low-fat/low-calorie diets in the management of obesity and its comorbidities. [2022]
Adherence to low-carbohydrate and low-fat diets in relation to weight loss and cardiovascular risk factors. [2021]
Progressing Insights into the Role of Dietary Fats in the Prevention of Cardiovascular Disease. [2022]
Type 2 Myocardial Infarction Related to Very Low Carbohydrate Ketogenic Diet. [2022]
Efficacy and safety of very-low-calorie ketogenic diet: a double blind randomized crossover study. [2022]
Ketogenic diet in epileptic children: impact on lipoproteins and oxidative stress. [2017]
Effects of ketogenic diet on vascular function. [2017]
Low carbohydrate ketogenic diets reduce cardiovascular risk factor levels in obese or overweight patients with T2DM: A meta-analysis of randomized controlled trials. [2023]
Ketogenic Diet and Cardiac Substrate Metabolism. [2022]
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