Effects of Almonds on Cardiovascular Risk Factors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Impact of Almond Nut Consumption on Markers of CVD & Metabolic Health

NCT02907684

Cardiovascular Disease

COMPLETED NA

Almond Dose Response Study.

NCT00507520

Hyperlipidemia Diet Therapy Cardiovascular Disease

COMPLETED PHASE2

Effects of Walnuts on Central Blood Pressure, Arterial Stiffness Indices, Lipoproteins, and Other CVD Risk Factors

NCT02210767

Cardiovascular Disease

COMPLETED NA

The Effect of Palm Olein, Olive Oil and Lard and on Risk Markers of Cardiovascular Disease

NCT00743301

Cardiovascular Disease Metabolic Syndrome

UNKNOWN NA

Human Intervention Study for Validating Foods With Improved Nutrient Profile

NCT04113837

Cardiovascular Risk Factor

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiovascular Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Almond

Group Type EXPERIMENTAL

Almonds

Intervention Type OTHER

1.5 oz almonds/day

Muffin

Group Type PLACEBO_COMPARATOR

Almonds

Intervention Type OTHER

1.5 oz almonds/day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Almonds

1.5 oz almonds/day

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes