Effects of Almonds on Cardiovascular Risk Factors (ALD)
Status
Conditions
Treatments
Details and patient eligibility
About
The purpose of this research is to build the evidence base for approval of FDA health claims related to almonds and cardiovascular disease. A randomized, 2-period, crossover controlled feeding study was designed to compare the effects of two blood cholesterol lowering diets that meet the American Heart Association recommendations. The nutrient profiles of the control diet (no almonds/day) and almond diet (1.5 oz. of almonds/day) are matched for protein, saturated fat, and cholesterol. The study population consists of two cohorts of 25 men and women with moderately elevated LDL-C. The investigators hypothesize that a cholesterol-lowering diet designed with almonds confers greater cardioprotective effects than a cholesterol-lowering diet without almonds on the basis of the LDL-C lowering response, effect on LDL particle size, abdominal adiposity and vascular health.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- BMI (20-35)
- Low density lipoprotein cholesterol males (128-194mg/dL) and females (121-190 mg/dL)
Exclusion criteria
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Pregnant, planning to become pregnant, or lactating
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Smoking; cholesterol-lowering medication
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Glucose-lowering medication
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Over the counter cholesterol-lowering substances (e.g.: psyllium, fish oil, soy lecithin, phytoestrogen)
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The following medical conditions:
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heart disease
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stroke
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Heart attack
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blood pressure >140/90
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diabetes
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renal or kidney disease
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rheumatoid arthritis
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blood clotting disorder
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liver disease or cirrhosis
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compromised immune system
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peripheral vascular disease or circulation problems
*> 10% body weight loss in the past 6 months
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vegetarian
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nut allergies
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Trial design
Primary purpose
Allocation
Interventional model
Masking
61 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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