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Dietary Fats for Vascular Health (PPMS Trial)
N/A
Recruiting
Led By Ryan Snodgrass, PhD
Research Sponsored by USDA, Western Human Nutrition Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Awards & highlights
PPMS Trial Summary
This trial studies effects of dietary fat on immune cells in the blood after a high-fat meal. It tests how different types of fat affect vessel health.
Who is the study for?
This study is for healthy adults aged 18-39 with a BMI of 18.5 to 29.9, who have no allergies to meal ingredients and no chronic diseases requiring daily medication. Participants must not be on certain medications, pregnant, or have recent surgeries or hospitalizations.Check my eligibility
What is being tested?
The trial investigates how two high-fat meals (one rich in saturated fat and the other in mono unsaturated fat) affect immune cells called non-classical monocytes after eating. The focus is on these cells' role in blood vessel health post-meal.See study design
What are the potential side effects?
Since this trial involves consumption of high-fat meals rather than drugs, typical drug side effects are not expected. However, individuals may experience digestive discomfort due to the nature of the challenge meals.
PPMS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Monocyte subsets
Secondary outcome measures
Change in CD14 gene expression
Change in CD16 gene expression
Change in CD45 gene expression
+35 morePPMS Trial Design
2Treatment groups
Experimental Treatment
Group I: High saturated fat challenge meal followed by high mono-unsaturated fat challenge mealExperimental Treatment2 Interventions
High saturated fat mixed macronutrient challenge meal with palm oil followed by high mono-unsaturated fat mixed macronutrient challenge meal with olive oil two weeks later
Group II: High mono-unsaturated fat challenge meal followed by high saturated fat challenge mealExperimental Treatment2 Interventions
High mono-unsaturated fat mixed macronutrient challenge meal with olive oil followed by high saturated fat mixed macronutrient challenge meal with palm oil two weeks later
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Who is running the clinical trial?
USDA, Western Human Nutrition Research CenterLead Sponsor
62 Previous Clinical Trials
21,077 Total Patients Enrolled
Ryan Snodgrass, PhDPrincipal InvestigatorUSDA, Western Human Nutrition Research Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had surgery on my stomach or intestines.I was hospitalized within the last 4 weeks.I have not had minor surgery in the last 4 weeks or major surgery in the last 16 weeks.I have not taken antibiotics in the last 4 weeks.I have had gallbladder issues or my gallbladder removed.I am currently taking medication that could affect the study's results.I am taking daily medication for a chronic condition like diabetes or heart disease.I am either younger than 18 or older than 39.I have HIV/AIDS or another immune system condition.
Research Study Groups:
This trial has the following groups:- Group 1: High saturated fat challenge meal followed by high mono-unsaturated fat challenge meal
- Group 2: High mono-unsaturated fat challenge meal followed by high saturated fat challenge 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.
Is eligibility for this research endeavor restricted to individuals over 50 years old?
"Eligible participants are aged 18 and younger than 39."
Answered by AI
Could I sign up for this clinical research study?
"This clinical trial requires prospective patients to have immunocompetence, and be within the 18-39 age range. Approximately 30 participants will be selected for this study."
Answered by AI
Are there still opportunities for participants to register in this research?
"According to clinicaltrials.gov, the trial is no longer recruiting participants at this time; it had been initially listed on April 1st 2023 and was recently amended March 29th of that year. In contrast, there are 371 other trials currently open for enrolment."
Answered by AI
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