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Avocado Diet for High Triglycerides
N/A
Recruiting
Research Sponsored by Midwest Center for Metabolic and Cardiovascular Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at baseline and end of each treatment period
Awards & highlights
Study Summary
This trial will help assess the positive effects of avocados on cholesterol levels and other aspects of heart health.
Who is the study for?
This trial is for men and women aged 21-74 with a BMI of 25-39.99, non-smokers who don't use nicotine or recreational drugs, and have fasting triglycerides between 135-499 mg/dL. Participants should be in good health without extreme diets or significant weight changes recently, not on certain medications like beta-blockers or diabetes meds within the last month, and willing to follow diet instructions.Check my eligibility
What is being tested?
The study aims to see if replacing solid fats and added sugars (SoFAS) in an average American diet with avocado can improve heart health by lowering bad cholesterol levels (non-HDL-C), improving insulin sensitivity, blood pressure, and other cardiometabolic factors in people with high triglycerides.See study design
What are the potential side effects?
Since this trial involves dietary changes rather than medication, side effects may include digestive discomfort due to increased fiber intake from avocados. Individual responses to dietary changes vary.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up 21 days for each treatment period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up 21 days for each treatment period
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Non-HDL-C
Secondary outcome measures
Disposition index from the liquid meal tolerance test [LMTT] (a measure of pancreatic beta-cell function)
High-density lipoprotein cholesterol (HDL-C)
Homeostasis model assessments of insulin sensitivity (HOMA2-%S), insulin resistance (HOMA-IR, linear model) and beta-cell function (HOMA2-%B)
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Average American Diet With SoFAS Replaced With AvocadoExperimental Treatment1 Intervention
Average American diet with foods that provide the equivalent of 1 medium to large avocado per day. It is anticipated that energy from avocado would replace 12-15% of daily energy, roughly half from solid fats and half from added sugars (SoFAS).
Group II: Average American DietPlacebo Group1 Intervention
Average American diet based on macronutrient analyses from the most recent Nutrition and Health Examination Survey.
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Who is running the clinical trial?
Midwest Center for Metabolic and Cardiovascular ResearchLead Sponsor
20 Previous Clinical Trials
810 Total Patients Enrolled
Hass Avocado BoardOTHER
12 Previous Clinical Trials
719 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have tested positive for illegal drugs in a urine test.Your blood pressure is too high and not controlled with medication.You have very strict eating habits, like being a vegan or eating very few carbohydrates.You have taken beta-blockers or high-dose thiazide diuretics in the last 4 weeks.You have taken certain types of diabetes medications within 4 weeks before the screening.You have a medical condition that could make it hard to understand the study results.Your blood sugar level when you haven't eaten anything is higher than 126 mg/dL, or you have been diagnosed with type 1 or type 2 diabetes.You are allergic or intolerant to any foods.Your lab test results are considered important by the main doctor in charge of the study.You have been diagnosed with an eating disorder such as anorexia or bulimia nervosa.You have had cancer, except for non-melanoma skin cancer or a specific type of cervix cancer, in the past 2 years.You have taken corticosteroid pills or injections in the past 4 weeks.You have taken certain types of foods, herbs, or supplements that affect your cholesterol levels within 2 weeks before screening.You have a body mass index (BMI) between 25.00 and 39.99 kg/m2.The person's vein access score is between 7 and 10.You have taken cholesterol-lowering medications like statins, bile acid sequestrants, or fibrates within the last 4 weeks.You use CBD or THC and don't plan to change that during the study.You have a history of atherosclerotic cardiovascular disease, including conditions like peripheral arterial disease, abdominal aortic aneurysm, or carotid artery disease with certain symptoms or test results.Your fasting fingerstick triglyceride level is between 135 mg/dL and 500 mg/dL.Your weight has changed by more than 10 pounds in the last 3 months.You are between 21 and 74 years old.You have taken certain dietary supplements that can affect how your body processes carbohydrates in the past 2 weeks.You have a history of heavy drinking or drug abuse in the past year, or are likely to abuse drugs or alcohol during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Average American Diet With SoFAS Replaced With Avocado
- Group 2: Average American Diet
Awards:
This trial has 0 awards, including: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.
Who else is applying?
What state do they live in?
Indiana
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Typically responds via
Phone Call
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