Effects of Almonds on Cardiovascular Risk Factors

Cardiovascular Disease Clinical Trial

— ALD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01101230
• Other study ID #: PKE 104
• Status: Completed
• Phase: N/A
• Start date: September 2009
• Est. completion date: May 2012

Study information

• Verified date: August 2023
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Other:
• Almonds
1.5 oz almonds/day

Locations

Country	Name	City	State
United States	Penn State University	University Park	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Penn State University	Almond Board of California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)