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Pecan Consumption for Cardiometabolic Health
N/A
Recruiting
Led By Jamie A Cooper, Ph.D.
Research Sponsored by University of Georgia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Elevated cholesterol profiles defined as 'Borderline High' and/or 'at risk' in two or more of the following variables (total cholesterol: 180-239 mg/dL, LDL cholesterol 110-159 mg/dL, triglycerides 130-199 mg/dL) or 'High' in total cholesterol (240 mg/dL and higher), LDL (160 mg/dL or higher), or triglycerides (between 200-350 mg/dl)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 2, week 4
Awards & highlights
Study Summary
This trial will test how eating pecans daily affects cardiometabolic health and hunger/satiety. Participants will consume pecans & have their blood drawn for 28 days.
Who is the study for?
This trial is for men and women aged 30-75 with overweight or obesity (BMI >28 kg/m2) and elevated cholesterol levels. It's not for those planning to change their diet/exercise, with food allergies to nuts/gluten/dairy, on special diets like keto or vegetarian, using certain medications, smokers, pregnant/lactating women, or with a history of serious health conditions.Check my eligibility
What is being tested?
The study tests the effects of daily pecan consumption at different doses (low, mid, high) compared to no pecans (control) over 28 days. Researchers will monitor changes in blood lipids and markers of hunger/satiety after a standard breakfast meal.See study design
What are the potential side effects?
Since this trial involves eating pecans which are generally safe foods there may be minimal side effects; however individuals might experience digestive discomfort if they're not used to high fiber intake.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cholesterol levels are borderline high or at risk in two or more categories, or high in any.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 1, week 2, week 3, week 4
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 1, week 2, week 3, week 4
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in fasting and postprandial plasma Malondialdehyde (MDA)
Change in fasting and postprandial plasma angiopoietin-like (ANGPTL) proteins
Change in fasting and postprandial plasma antioxidant parameters
+12 moreSecondary outcome measures
Change in acute dietary intake
Change in additional fasting and postprandial plasma inflammatory cytokine concentrations
Change in additional fasting and postprandial plasma markers of coagulation potential
+4 moreOther outcome measures
Change in anthropometric circumferences
Change in anxiety
Change in blood pressure
+12 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Pecan MIDExperimental Treatment1 Intervention
Participants are given pecans and instructed on how to substitute study foods into their diet to maintain caloric balance.
Group II: Pecan LOWExperimental Treatment1 Intervention
Participants are given pecans and instructed on how to substitute study foods into their diet to maintain caloric balance.
Group III: Pecan HIGHExperimental Treatment1 Intervention
Participants are given pecans and instructed on how to substitute study foods into their diet to maintain caloric balance.
Group IV: CONTROLExperimental Treatment1 Intervention
Participants are asked to maintain their current habitual diet and avoid any tree nut/peanut consumption for the entire 28-day intervention period.
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Who is running the clinical trial?
University of GeorgiaLead Sponsor
102 Previous Clinical Trials
34,682 Total Patients Enrolled
1 Trials studying Dyslipidemia
90 Patients Enrolled for Dyslipidemia
Jamie A Cooper, Ph.D.Principal InvestigatorUniversity of Georgia
2 Previous Clinical Trials
125 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are significantly above a healthy weight based on your body mass index (BMI).Your blood pressure is higher than 180/120 mmHg.You smoke or use nicotine products.I have a history of issues that could affect my digestion or swallowing.I have been on hormone replacement therapy for less than 2 years.You are following a specific diet like keto, intermittent fasting, vegetarian, or low-carb diet.My cholesterol levels are borderline high or at risk in two or more categories, or high in any.I have had a heart attack or stroke, or I have been diagnosed with cancer.Your blood sugar level when you haven't eaten is higher than 126 mg/dL.I likely have familial hypercholesterolemia with high cholesterol and a family history of early heart attacks.I am between 30 and 75 years old with high cholesterol or I am overweight.My weight has changed by more than 5% in the last 3 months.I have had gastrointestinal surgery, atherosclerosis, or a bleeding disorder.I have a long-term illness like diabetes or heart disease.You eat a lot of nuts or nut butter every week.I am not pregnant or breastfeeding.You exercise more than 3 hours per week.I have had kidney or bowel disease in the past or currently.I am not on medication that affects digestion, metabolism, blood thinning, or diabetes.I drink more than 3 (if male) or 2 (if female) alcoholic drinks daily.You are planning to start a diet or exercise program during the study.You are allergic to the foods provided in the study, such as tree nuts, gluten, and dairy.I am currently on steroids, hormone therapies, or antibiotics.
Research Study Groups:
This trial has the following groups:- Group 1: Pecan LOW
- Group 2: Pecan MID
- Group 3: Pecan HIGH
- Group 4: CONTROL
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.
Does this trial allow for elderly enrollment?
"The prerequisites for eligibility stipulate that patients must be between 30 and 75 years of age. There are 72 trials available to minors under 18, while 297 clinical studies are reserved for seniors above 65."
Answered by AI
To whom is enrollment for this experiment available?
"This trial requires eligible candidates to have a diagnosis of dyslipidemia and be between 30-75 years old. The desired participant count is roughly 80 individuals."
Answered by AI
What is the desired outcome of this clinical experiment?
"This trial, observed over a period of 4 weeks from the Baseline, seeks to determine changes in fasting serum lipoprotein numbers. Secondary outcomes include modifications in hepatic proteins (Total protein and albumin), bilirubin levels (Total total bilirubin, direct bilirubin, and indirect bilirubin) as well as alterations in circulating monocyte chemoattractant protein-1 and interleukin-10 concentrations before and after a high saturated fat meal challenge at both pre-and post-intervention visits."
Answered by AI
Are there any more volunteers being sought for this experiment?
"According to clinicaltrials.gov, this trial has ended its recruitment process and the last edit was made on July 9th 2023. Nonetheless, 464 other trials are actively recruiting patients at present."
Answered by AI
Who else is applying?
What site did they apply to?
University of Georgia
What portion of applicants met pre-screening criteria?
Met criteria
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