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

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 2,697-participant average among 137 other Cardiovascular Disease trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

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).

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
Penn State University

219 total trials

What the finished NCT01101230 record still lists

NCT01101230 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 2,697-participant average among 137 other Cardiovascular Disease trials with a reported enrollment target (98% lower).

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 a single indexed study location in 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.

Similar trials for Cardiovascular Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01101230's enrollment target sits among peer trials

61 100th of 137 higher than 38 of 137 other Cardiovascular Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Cardiovascular Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01101230, the US trial registry maintained by the National Library of Medicine. NCT01101230 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.