Effects of Almonds on Cardiovascular Risk Factors (ALD)

This study has been completed.
Sponsor:
Collaborator:
Almond Board of California
Information provided by (Responsible Party):
Penny Kris-Etherton, Penn State University
ClinicalTrials.gov Identifier:
NCT01101230
First received: March 24, 2010
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Cardiovascular Disease
Other: Almonds

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effects of a Diet Rich in Almonds on LDL Cholesterol, LDL Particle Size, Abdominal Adiposity and Vascular Health

Resource links provided by NLM:


Further study details as provided by Penn State University:

Primary Outcome Measures:
  • Lipid/lipoprotein profile [ Time Frame: End of diet period 1 (week 6) and diet period 2 (week 14) ] [ Designated as safety issue: No ]

    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:
  • Additional lipid/lipoprotein measures (VLDL, IDL, and remnant lipoproteins) [ Time Frame: End of diet period 1 (week 6) and diet period 2 (week 14) ] [ Designated as safety issue: No ]
    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 [ Time Frame: End of diet period 1 (week 6) and diet period 2 (week 14) ] [ Designated as safety issue: No ]
    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 [ Time Frame: End of diet period 1 (week 6) and diet period 2 (week 14) ] [ Designated as safety issue: No ]
    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 [ Time Frame: End of diet period 1 (week 6) and diet period 2 (week 14) ] [ Designated as safety issue: No ]
    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) [ Time Frame: End of diet period 1 (week 6) and diet period 2 (week 14) ] [ Designated as safety issue: No ]
    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) [ Time Frame: End of diet period 1 (week 6) and diet period 2 (week 14) ] [ Designated as safety issue: No ]
    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 [ Time Frame: End of diet period 1 (week 6) and diet period 2 (week 14) ] [ Designated as safety issue: No ]
    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 [ Time Frame: End of diet period 1 (week 6) and diet period 2 (week 14) ] [ Designated as safety issue: No ]
    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).

  • HDL functionality (cholesterol efflux) [ Time Frame: End of diet period 1 (week 6) and diet period 2 (week 14) ] [ Designated as safety issue: No ]
    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) [ Time Frame: End of diet period 1 (week 6) and diet period 2 (week 14) ] [ Designated as safety issue: No ]
    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).


Enrollment: 61
Study Start Date: September 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Almond Other: Almonds
1.5 oz almonds/day
Placebo Comparator: Muffin Other: Almonds
1.5 oz almonds/day

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01101230

Locations
United States, Pennsylvania
Penn State University
University Park, Pennsylvania, United States, 16802
Sponsors and Collaborators
Penn State University
Almond Board of California
Investigators
Principal Investigator: Penny M Kris-Etherton Penn State University
Study Director: Claire E Berryman Penn State University
  More Information

No publications provided

Responsible Party: Penny Kris-Etherton, Distinguished Professor of Nutrition, Penn State University
ClinicalTrials.gov Identifier: NCT01101230     History of Changes
Other Study ID Numbers: PKE 104
Study First Received: March 24, 2010
Last Updated: November 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Penn State University:
Cardiovascular disease
cholesterol
low-density
lipoprotein
high-density lipoprotein
triglycerides

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 19, 2014