NCT01101230

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2010

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 9, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

2.7 years

First QC Date

March 24, 2010

Last Update Submit

August 16, 2023

Conditions

Cardiovascular Disease

Keywords

Cardiovascular diseasecholesterollow-densitylipoproteinhigh-density lipoproteintriglycerides

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

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

    End of diet period 1 (week 6) and diet period 2 (week 14)

  • Lipoprotein (LDL, HDL, VLDL, IDL) subclasses

    End of diet period 1 (week 6) and diet period 2 (week 14)

  • Abdominal adiposity as measured by dual-energy x-ray absorptiometry

    End of diet period 1 (week 6) and diet period 2 (week 14)

  • Leg adiposity as measured by dual-energy x-ray absorptiometry

    End of diet period 1 (week 6) and diet period 2 (week 14)

  • Apolipoproteins (A1 and B)

    End of diet period 1 (week 6) and diet period 2 (week 14)

  • +5 more secondary outcomes

Study Arms (2)

Almond

EXPERIMENTAL
Other: Almonds

Muffin

PLACEBO COMPARATOR
Other: Almonds

Interventions

AlmondsOTHER

1.5 oz almonds/day

AlmondMuffin

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI (20-35)
  • Low density lipoprotein cholesterol males (128-194mg/dL) and females (121-190 mg/dL)

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State University

University Park, Pennsylvania, 16802, United States

Location

Related Publications (2)

  • Berryman CE, Fleming JA, Kris-Etherton PM. Inclusion of Almonds in a Cholesterol-Lowering Diet Improves Plasma HDL Subspecies and Cholesterol Efflux to Serum in Normal-Weight Individuals with Elevated LDL Cholesterol. J Nutr. 2017 Aug;147(8):1517-1523. doi: 10.3945/jn.116.245126. Epub 2017 Jun 14.

    PMID: 28615375DERIVED

  • Berryman CE, West SG, Fleming JA, Bordi PL, Kris-Etherton PM. Effects of daily almond consumption on cardiometabolic risk and abdominal adiposity in healthy adults with elevated LDL-cholesterol: a randomized controlled trial. J Am Heart Assoc. 2015 Jan 5;4(1):e000993. doi: 10.1161/JAHA.114.000993.

    PMID: 25559009DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Penny M Kris-Etherton

    Penn State University

    PRINCIPAL INVESTIGATOR

  • Claire E Berryman

    Penn State University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2010

First Posted

April 9, 2010

Study Start

September 1, 2009

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

August 21, 2023

Record last verified: 2023-08

Locations

US(1)