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Lipid Metabolism Modulator
High Saturated Fat Diet for Peripheral Vascular Disease
N/A
Recruiting
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Healthy adults aged 18-40 years
English-speaking only
Timeline
Screening 3 weeks
Treatment Varies
Follow Up year 2
Awards & highlights
Study Summary
This trial aims to study how artery and microvascular function is affected by eating fats with long or medium chain fatty acids.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects aren't listed for consuming a single high-fat meal as part of this study, potential short-term reactions could include gastrointestinal discomfort such as bloating or indigestion.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a healthy adult between 18 and 40 years old.
Select...
I speak English.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ year 2
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year 2
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Endothelial-Dependent Total Vessel Density
Percentage of Cardiovascular Conductance
Secondary outcome measures
Reactive Hyperemia
Trial Design
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.
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Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
610 Previous Clinical Trials
1,162,693 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 18 or over 40 years old and healthy.I have heart failure.I have been diagnosed with coronary artery disease.I am a healthy adult between 18 and 40 years old.I have diabetes.You currently smoke or use tobacco products.I have high blood pressure.I have not had chemotherapy in the last 6 months.You have high levels of cholesterol in your blood.You are unable to digest lactose or have an allergy to dairy products.I speak English.Your blood pressure is either too low (less than 100) or too high (more than 160).I have visible sores or wounds in my mouth.Your heart beats too slowly or too quickly.I do not speak English.
Research Study Groups:
This trial has the following groups:- Group 1: Medium Chain Fatty Acid High Fat Meal
- Group 2: Long Chain Fatty Acid High Fat Meal
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the eligibility criteria for participating in this research?
"To partake in this medical trial, individuals must have peripheral vascular disease and be aged between 18 and 40. Approximately twenty patients are required for the study's completion."
Answered by AI
Does this research require individuals to be within a certain age bracket?
"This research is seeking participants who are between 18 and 40 years of age."
Answered by AI
Is there still room for individuals to join this medical experiment?
"The clinical trial is still open to applicants, as confirmed by information on the official website. It was initially posted in May 1st 2023 and its most recent update occurred 15 days later."
Answered by AI
How many participants have been recruited for this clinical experiment?
"Affirmative. Clinicaltrials.gov reveals that this research project, which was posted on May 1st 2023, still requires participants to join. In total, the trial is recruiting for around twenty individuals at a single medical site."
Answered by AI
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