Skip to main content
OpenTrials
Completed

NCT Number: NCT01101230

Effects of Almonds on Cardiovascular Risk Factors

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State University

University Park, Pennsylvania, 16802, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Almonds

Other

1.5 oz almonds/day

Primary outcomes

  1. Lipid/lipoprotein profile

    Time frame: 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 outcomes

  1. Additional lipid/lipoprotein measures (VLDL, IDL, and remnant lipoproteins)

    Time frame: 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).

  2. Lipoprotein (LDL, HDL, VLDL, IDL) subclasses

    Time frame: 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).

  3. Abdominal adiposity as measured by dual-energy x-ray absorptiometry

    Time frame: 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).

  4. Leg adiposity as measured by dual-energy x-ray absorptiometry

    Time frame: 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).

  5. Apolipoproteins (A1 and B)

    Time frame: 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).

  6. Vascular health (plasma nitric oxide)

    Time frame: 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).

  7. Total body composition as measured by dual-energy x-ray absorptiometry

    Time frame: 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).

  8. Waist circumference

    Time frame: 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).

  9. HDL functionality (cholesterol efflux)

    Time frame: 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).

  10. Cholesterol absorption/synthesis (measured by plasma plant sterols and cholesterol precursors)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • Almond Board of California

Registry information

Official study title

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

Acronym: ALD

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Apr 9, 2010
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.