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Western Diet for Heart Disease Risk
N/A
Recruiting
Led By Jamy Ard, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 20-45
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in at the endpoint of week 8
Awards & highlights
Study Summary
This trial will study the effects of a Western diet on monocyte priming in humans.
Who is the study for?
This trial is for healthy, normal-weight individuals aged 20-45 who don't smoke or drink excessively. Participants must be free of chronic heart and metabolic diseases, not pregnant or breastfeeding, and able to commit to the study period without working night shifts.Check my eligibility
What is being tested?
The trial is testing how a Western diet affects monocyte priming in metabolically healthy adults. The diet is high in saturated fats, fructose, and calories. Subjects will follow this experimental diet strictly for 8 weeks to track changes.See study design
What are the potential side effects?
Potential side effects may include weight gain, increased cholesterol levels, higher blood pressure, and potential negative impacts on heart health due to the nature of the high-fat, high-calorie diet.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 20 and 45 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change in at the endpoint of week 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in at the endpoint of week 8
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Measurement of Mitogen-activated protein kinase phosphate 1 (MKP-1) activity
Secondary outcome measures
Measurement of Monocyte protein S-glutathionylation
Other outcome measures
RNA, Messenger
Trial Design
1Treatment groups
Experimental Treatment
Group I: Experimental dietExperimental Treatment1 Intervention
The experimental diet will provide 15% of calories from saturated fat and 14% of calories from fructose with a goal of providing 1.25x total energy needs
Find a Location
Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,837 Previous Clinical Trials
47,851,597 Total Patients Enrolled
Wake Forest University Health SciencesLead Sponsor
1,242 Previous Clinical Trials
1,004,237 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,700 Previous Clinical Trials
7,506,846 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are within a certain healthy weight range based on your height.I am between 20 and 45 years old.You work at night.I have a chronic condition like diabetes, high blood pressure, high cholesterol, or heart disease.You do not smoke cigarettes.You drink too much alcohol.I need extra oxygen due to severe lung problems.You recently changed your weight and reported it yourself.I have had surgery for weight control or liposuction.I have not taken weight loss medications in the last 6 months.My kidney or liver is not functioning properly.I have had a non-skin cancer diagnosis within the last 5 years.I regularly take medication that affects my blood pressure, cholesterol, blood sugar, inflammation, or weight.You do a lot of exercise every week, like more than 7 hours of moderate activity or more than 3.5 hours of vigorous activity.You have allergies or trouble eating the foods in the study diets.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental diet
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.
Are new participants being taken into this study at present?
"According to the information on clinicaltrials.gov, this particular research project is not currently seeking participants; it was posted in December 1st 2022 and last updated October 31st 2022. Nonetheless, there are 320 other medical studies that require patients at present."
Answered by AI
What are the requirements for individuals to be accepted into this scientific research?
"From a pool of applicants aged 20-45, this medical trial is accepting 30 participants with heart diseases. To be considered for the study period, patients must possess some key attributes: command English fluently, have an average BMI (18.5 - 24.9 kg/m2), commit to eating the designated diet, and not smoke cigarettes or related substances."
Answered by AI
Does this medical experiment have any age restrictions?
"Conforming to this clinical trial's inclusion criteria, the minimum age of participation is 20 years old and maximum age cannot exceed 45."
Answered by AI
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