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NCT01101230 · ClinicalTrials.gov registry record · NA

Effects of Almonds on Cardiovascular Risk Factors

A NA study of Cardiovascular Disease, sponsored by Penn State University.

Completed
Registry status
NA
Development phase
61
Enrollment target
1
Study location

NCT01101230 is a NA study of Cardiovascular Disease that has completed, run by Penn State University. The registered enrollment target is 61 participants, below the 2,713-participant average among 136 other Cardiovascular Disease trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01101230, a NA study of Cardiovascular Disease, has completed, sponsored by Penn State University.

COMPLETED
Registry status
NA
Development phase
61 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Interventions

  • OTHER Almonds

Study Locations (1)

Pennsylvania

  • Penn State University - University Park

Trial Details

FieldValue
Enrollment Target 61 participants
Start Date 2009-09
Est. Completion 2012-05
Phase NA

Sponsor

Penn State University

219 total trials

What the Registry Record Tells You About NCT01101230

The ClinicalTrials.gov registry entry for NCT01101230 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,713-participant average among 136 other Cardiovascular Disease trials with a reported enrollment target (98% lower). The listed sponsor is Penn State University, which has 219 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Cardiovascular Disease appearing as the primary indexed condition, and to 1 intervention - of which Almonds is the first listed.

NCT01101230 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT01101230 about?

NCT01101230 is a clinical study titled "Effects of Almonds on Cardiovascular Risk Factors". 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 He...

What is the current status of trial NCT01101230?

This trial is currently completed. It is a NA study. The enrollment target is 61 participants. The study started on 2009-09. Estimated completion is 2012-05.

What conditions does trial NCT01101230 study?

This clinical trial studies the following conditions: Cardiovascular Disease.

What interventions are being tested in trial NCT01101230?

The interventions under investigation include: Almonds (OTHER).

Who is sponsoring clinical trial NCT01101230?

This trial is sponsored by Penn State University, which has 219 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01101230 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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