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Almonds for Metabolic Syndrome
N/A
Waitlist Available
Led By Laura Beaver, PhD
Research Sponsored by Oregon State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Presence of 3 or more of the following conditions: hypertension (systolic BP 130-179 mmHg or diastolic BP 85-119 mmHg), hyperglycemia (fasting glucose 100-599 mg/dL), central obesity [waist circumference greater than 40.1 inches (M) or 34.6 inches (F)], hypertriglyceridemia (150-499 mg/dL), low HDL [lower than 40 mg/dL (M) or 50 mg/dL (F)]
Age 35-60 years
Must not have
Tobacco use, including e-cigarettes, or smoking of any substance (e.g. cannabis) in the past 3 months
Diagnosis of hemochromatosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 4 and 12 weeks
Summary
This trial will study how eating almonds everyday affects gut health and inflammation in persons with metabolic syndrome.
Who is the study for?
Adults aged 35-60 with metabolic syndrome, willing to eat almonds daily and avoid other nuts, probiotics, multivitamins, and certain supplements for 13 weeks. Participants should have hypertension, high blood sugar, central obesity or abnormal cholesterol levels but no allergies to nuts/wheat/gluten, heavy alcohol use, recent tobacco use or antibiotic intake.
What is being tested?
The trial is testing if consuming almonds every day for 12 weeks can improve gut health and reduce inflammation in people with metabolic syndrome. The effects on metabolism and heart health will be monitored along with the impact of almond-derived nutrients.
What are the potential side effects?
Potential side effects are not specified for eating almonds; however common concerns may include digestive discomfort or allergic reactions in those who might develop sensitivities.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have three or more of the following: high blood pressure, high blood sugar, large waist size, high triglycerides, or low HDL cholesterol.
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I am between 35 and 60 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not used tobacco or smoked any substance in the last 3 months.
Select...
I have been diagnosed with hemochromatosis.
Select...
I have a history of heart, liver disease, or another type of cancer.
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I am currently taking ezetimibe or orlistat.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0, 4 and 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 4 and 12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Biomarkers of inflammation
Cardiometabolic health
Gut permeability and health: Inflammatory biomarkers
+6 moreSecondary study objectives
BMI
Blood pressure
Glycemic control: HOMA-IR
+6 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: AlmondsActive Control1 Intervention
Daily consumption of 2 ounces of unsalted, dry roasted almonds for 12 weeks
Group II: CrackersPlacebo Group1 Intervention
Daily consumption of non-whole grain crackers for 12 weeks (caloric equivalent to 2 ounces of dry roasted almonds)
Find a Location
Who is running the clinical trial?
Oregon State UniversityLead Sponsor
50 Previous Clinical Trials
8,354 Total Patients Enrolled
1 Trials studying Metabolic Syndrome
48 Patients Enrolled for Metabolic Syndrome
Laura Beaver, PhDPrincipal InvestigatorOregon State University
Media Library
Awards:
This trial has 0 awards, including: