Effects of Almonds on Cardiovascular Risk Factors

Not Applicable

Completed

• Conditions: Cardiovascular Disease
• Interventions: Other: Almonds

• Registration Number: NCT01101230
• Lead Sponsor: Penn State University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-03-24
• Study First Submitted QC: 2010-04-08
• Study First Posted: 2010-04-09
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-16
• Last Update Posted: 2023-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Muffin	Almonds	-
Almond	Almonds	-

Primary Outcome Measures

Name	Time	Method
Lipid/lipoprotein profile	End of diet period 1 (week 6) and diet period 2 (week 14)	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).

Secondary Outcome Measures

Name	Time	Method
HDL functionality (cholesterol efflux)	End of diet period 1 (week 6) and diet period 2 (week 14)	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).
Cholesterol absorption/synthesis (measured by plasma plant sterols and cholesterol precursors)	End of diet period 1 (week 6) and diet period 2 (week 14)	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).
Waist circumference	End of diet period 1 (week 6) and diet period 2 (week 14)	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).
Additional lipid/lipoprotein measures (VLDL, IDL, and remnant lipoproteins)	End of diet period 1 (week 6) and diet period 2 (week 14)	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).
Lipoprotein (LDL, HDL, VLDL, IDL) subclasses	End of diet period 1 (week 6) and diet period 2 (week 14)	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).
Leg adiposity as measured by dual-energy x-ray absorptiometry	End of diet period 1 (week 6) and diet period 2 (week 14)	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).
Abdominal adiposity as measured by dual-energy x-ray absorptiometry	End of diet period 1 (week 6) and diet period 2 (week 14)	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).
Apolipoproteins (A1 and B)	End of diet period 1 (week 6) and diet period 2 (week 14)	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).
Vascular health (plasma nitric oxide)	End of diet period 1 (week 6) and diet period 2 (week 14)	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).
Total body composition as measured by dual-energy x-ray absorptiometry	End of diet period 1 (week 6) and diet period 2 (week 14)	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).

Trial Locations

Locations (1)

Penn State University; 🇺🇸 University Park, Pennsylvania, United States