Clinical trial NCT01101230: Effects of Almonds on Cardiovascular Risk Factors
Official title: Effects of a Diet Rich in Almonds on LDL Cholesterol, LDL Particle Size, Abdominal Adiposity and Vascular Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: Cardiovascular disease
cholesterol
low-density
lipoprotein
high-density lipoprotein
triglycerides
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: Almond Board of California
First posted: 2010-04-09
Enrollment: 61
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Lipid/lipoprotein profile
timeFrame: End of diet period 1 (week 6) and diet period 2 (week 14)
Secondary outcomes:
measure: Additional lipid/lipoprotein measures (VLDL, IDL, and remnant lipoproteins)
timeFrame: End of diet period 1 (week 6) and diet period 2 (week 14)
measure: Lipoprotein (LDL, HDL, VLDL, IDL) subclasses
timeFrame: End of diet period 1 (week 6) and diet period 2 (week 14)
measure: Abdominal adiposity as measured by dual-energy x-ray absorptiometry
timeFrame: End of diet period 1 (week 6) and diet period 2 (week 14)
measure: Leg adiposity as measured by dual-energy x-ray absorptiometry
timeFrame: End of diet period 1 (week 6) and diet period 2 (week 14)
measure: Apolipoproteins (A1 and B)
timeFrame: End of diet period 1 (week 6) and diet period 2 (week 14)
measure: Vascular health (plasma nitric oxide)
timeFrame: End of diet period 1 (week 6) and diet period 2 (week 14)
measure: Total body composition as measured by dual-energy x-ray absorptiometry
timeFrame: End of diet period 1 (week 6) and diet period 2 (week 14)
measure: Waist circumference
timeFrame: End of diet period 1 (week 6) and diet period 2 (week 14)
measure: HDL functionality (cholesterol efflux)
timeFrame: End of diet period 1 (week 6) and diet period 2 (week 14)
measure: Cholesterol absorption/synthesis (measured by plasma plant sterols and cholesterol precursors)
timeFrame: End of diet period 1 (week 6) and diet period 2 (week 14)
Other outcomes:
Locations:
city: University Park
country: United States
facility: Penn State University
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Penny M Kris-Etherton
role: PRINCIPAL_INVESTIGATOR
affiliation: Penn State University
name: Claire E Berryman
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.