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High Protein Diet for Atherosclerosis (HPA Trial)
N/A
Recruiting
Led By Bettina Mittendorfer
Research Sponsored by University of Missouri-Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
>=45 and <=75 years of age
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from at 1 hour before meal intake and 3 hours after the meal
Awards & highlights
HPA Trial Summary
This trial will explore the relationship between protein intake and the pathogenesis of atherosclerosis, with the hypothesis that high protein intake drives atherosclerosis.
Who is the study for?
This trial is for adults aged 45-75 with a BMI of 25.0 to less than 40.0 kg/m2, who do not smoke and have no significant organ dysfunction or allergies to meal ingredients. It excludes those on certain medications or supplements, highly active individuals, alcohol users with disorders, premenopausal women, prisoners, and anyone unable to consent.Check my eligibility
What is being tested?
The study tests the effects of different diets on atherosclerosis: high plant protein meals (with and without extra leucine), standard meals, and high animal protein meals. The focus is on how these diets might influence heart disease by affecting plaque in arteries.See study design
What are the potential side effects?
While specific side effects are not listed for diet interventions like these, participants may experience changes in digestion or energy levels due to dietary adjustments.
HPA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 45 and 75 years old.
HPA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from at 1 hour before meal intake and 3 hours after the meal
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from at 1 hour before meal intake and 3 hours after the meal
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Monocyte p-S6 content
HPA Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: High plant protein meal with additional leucineExperimental Treatment1 Intervention
Group II: High plant protein mealExperimental Treatment1 Intervention
Group III: High animal protein mealExperimental Treatment1 Intervention
Group IV: Standard mealActive Control1 Intervention
Find a Location
Who is running the clinical trial?
University of Missouri-ColumbiaLead Sponsor
362 Previous Clinical Trials
628,090 Total Patients Enrolled
2 Trials studying Atherosclerosis
10 Patients Enrolled for Atherosclerosis
Washington University School of MedicineLead Sponsor
1,935 Previous Clinical Trials
2,299,783 Total Patients Enrolled
7 Trials studying Atherosclerosis
3,659 Patients Enrolled for Atherosclerosis
Bettina MittendorferPrincipal InvestigatorUniversity of Missouri-Columbia
5 Previous Clinical Trials
260 Total Patients Enrolled
1 Trials studying Atherosclerosis
10 Patients Enrolled for Atherosclerosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood triglyceride level is less than 125 mg/dl.You exercise regularly for more than 150 minutes each week.I am between 45 and 75 years old.Your body mass index is between 25 and 40.I am a woman who has not gone through menopause.Your body mass index is not within the range of 25.0 to 39.9 kg/m2.I am between 45 and 75 years old.I am not taking any medications or supplements that could affect the study results.I am unable to understand and give voluntary consent for treatment.You have a problem with drinking too much alcohol.You are allergic or intolerant to any of the ingredients in the meals.I do not have any major organ system problems.People who smoke.
Research Study Groups:
This trial has the following groups:- Group 1: High plant protein meal
- Group 2: High animal protein meal
- Group 3: Standard meal
- Group 4: High plant protein meal with additional leucine
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 there any vacancies available in this research project?
"Current data hosted on clinicaltrials.gov reveals that this medical trial is not actively recruiting patients at the moment, having initially been posted in August 1st 2022 and last edited June 15th 2022. Nevertheless, there are 129 different studies now seeking participants."
Answered by AI
What criteria must participants fulfill to qualify for this medical experiment?
"This research endeavour is looking to recruit 24 individuals with atherogenesis who are between 45 and 75 years old. To qualify, the patient needs a body mass index that falls within 25.0 to 40.0 kg/m2 bracket."
Answered by AI
Are adults over the age of twenty permitted to participate in this investigation?
"This medical trial is enlisting patients 45 years and older, yet below 75."
Answered by AI
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