Effects of Almonds on Cardiovascular Risk Factors (ALD)

August 16, 2023 updated by: Penn State University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • University Park, Pennsylvania, United States, 16802
        • Penn State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Almond
Other: Almonds
1.5 oz almonds/day
Placebo Comparator: Muffin
Other: Almonds
1.5 oz almonds/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
End of diet period 1 (week 6) and diet period 2 (week 14)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
End of diet period 1 (week 6) and diet period 2 (week 14)
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).
End of diet period 1 (week 6) and diet period 2 (week 14)
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).
End of diet period 1 (week 6) and diet period 2 (week 14)
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).
End of diet period 1 (week 6) and diet period 2 (week 14)
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).
End of diet period 1 (week 6) and diet period 2 (week 14)
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).
End of diet period 1 (week 6) and diet period 2 (week 14)
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).
End of diet period 1 (week 6) and diet period 2 (week 14)
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).
End of diet period 1 (week 6) and diet period 2 (week 14)
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).
End of diet period 1 (week 6) and diet period 2 (week 14)
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).
End of diet period 1 (week 6) and diet period 2 (week 14)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Penn State University

Collaborators

Almond Board of California

Investigators

  • Principal Investigator: Penny M Kris-Etherton, Penn State University
  • Study Director: Claire E Berryman, Penn State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

March 24, 2010

First Submitted That Met QC Criteria

April 8, 2010

First Posted (Estimated)

April 9, 2010

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 16, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PKE 104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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