Effects of Almonds on Cardiovascular Risk Factors

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Effects of a Diet Rich in Almonds on LDL Cholesterol, LDL Particle Size, Abdominal Adiposity and Vascular Health

Conditions
-----------------
Cardiovascular Disease

Intervention / Treatment
-----------------
* Other: Almonds


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI (20-35) Low density lipoprotein cholesterol males (128-194mg/dL) and females (121-190 mg/dL) Exclusion Criteria: Pregnant, planning to become pregnant, or lactating Smoking; cholesterol-lowering medication Glucose-lowering medication Over the counter cholesterol-lowering substances (e.g.: psyllium, fish oil, soy lecithin, phytoestrogen) The following medical conditions: heart disease stroke Heart attack blood pressure >140/90 diabetes renal or kidney disease rheumatoid arthritis blood clotting disorder liver disease or cirrhosis compromised immune system peripheral vascular disease or circulation problems *> 10% body weight loss in the past 6 months vegetarian nut allergies

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Almond<br> | Other: Almonds<br>* 1.5 oz almonds/day<br>|
| Placebo Comparator: Muffin<br> | Other: Almonds<br>* 1.5 oz almonds/day<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid/lipoprotein profile | Total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides are measured as part of the lipoprotein profile. Diet period one runs for 6 weeks, then there is a 2 week compliance break, and then diet period two runs for 6 weeks (total time commitment is 14 weeks). | End of diet period 1 (week 6) and diet period 2 (week 14) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional lipid/lipoprotein measures (VLDL, IDL, and remnant lipoproteins) | Diet period one runs for 6 weeks, then there is a 2 week compliance break, and then diet period two runs for 6 weeks (total time commitment is 14 weeks). | End of diet period 1 (week 6) and diet period 2 (week 14) | 
| Lipoprotein (LDL, HDL, VLDL, IDL) subclasses | Diet period one runs for 6 weeks, then there is a 2 week compliance break, and then diet period two runs for 6 weeks (total time commitment is 14 weeks). | End of diet period 1 (week 6) and diet period 2 (week 14) | 
| Abdominal adiposity as measured by dual-energy x-ray absorptiometry | Diet period one runs for 6 weeks, then there is a 2 week compliance break, and then diet period two runs for 6 weeks (total time commitment is 14 weeks). | End of diet period 1 (week 6) and diet period 2 (week 14) | 
| Leg adiposity as measured by dual-energy x-ray absorptiometry | Diet period one runs for 6 weeks, then there is a 2 week compliance break, and then diet period two runs for 6 weeks (total time commitment is 14 weeks). | End of diet period 1 (week 6) and diet period 2 (week 14) | 
| Apolipoproteins (A1 and B) | Diet period one runs for 6 weeks, then there is a 2 week compliance break, and then diet period two runs for 6 weeks (total time commitment is 14 weeks). | End of diet period 1 (week 6) and diet period 2 (week 14) | 
| Vascular health (plasma nitric oxide) | Diet period one runs for 6 weeks, then there is a 2 week compliance break, and then diet period two runs for 6 weeks (total time commitment is 14 weeks). | End of diet period 1 (week 6) and diet period 2 (week 14) | 
| Total body composition as measured by dual-energy x-ray absorptiometry | Diet period one runs for 6 weeks, then there is a 2 week compliance break, and then diet period two runs for 6 weeks (total time commitment is 14 weeks). | End of diet period 1 (week 6) and diet period 2 (week 14) | 
| Waist circumference | Diet period one runs for 6 weeks, then there is a 2 week compliance break, and then diet period two runs for 6 weeks (total time commitment is 14 weeks). | End of diet period 1 (week 6) and diet period 2 (week 14) | 
| HDL functionality (cholesterol efflux) | Diet period one runs for 6 weeks, then there is a 2 week compliance break, and then diet period two runs for 6 weeks (total time commitment is 14 weeks). | End of diet period 1 (week 6) and diet period 2 (week 14) | 
| Cholesterol absorption/synthesis (measured by plasma plant sterols and cholesterol precursors) | Diet period one runs for 6 weeks, then there is a 2 week compliance break, and then diet period two runs for 6 weeks (total time commitment is 14 weeks). | End of diet period 1 (week 6) and diet period 2 (week 14) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiovascular disease, cholesterol, low-density, lipoprotein, high-density lipoprotein, triglycerides