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| Name | Class |
|---|---|
| Almond Board of California | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Almond | Experimental |
| |
| Muffin | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Almonds | Other | 1.5 oz almonds/day |
|
| 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) |
| 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 |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Penny M Kris-Etherton | Penn State University | Principal Investigator |
| Claire E Berryman | Penn State University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State University | University Park | Pennsylvania | 16802 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28615375 | Derived | Berryman CE, Fleming JA, Kris-Etherton PM. Inclusion of Almonds in a Cholesterol-Lowering Diet Improves Plasma HDL Subspecies and Cholesterol Efflux to Serum in Normal-Weight Individuals with Elevated LDL Cholesterol. J Nutr. 2017 Aug;147(8):1517-1523. doi: 10.3945/jn.116.245126. Epub 2017 Jun 14. | |
| 25559009 | Derived |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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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) |
| Berryman CE, West SG, Fleming JA, Bordi PL, Kris-Etherton PM. Effects of daily almond consumption on cardiometabolic risk and abdominal adiposity in healthy adults with elevated LDL-cholesterol: a randomized controlled trial. J Am Heart Assoc. 2015 Jan 5;4(1):e000993. doi: 10.1161/JAHA.114.000993. |