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Effects of Almonds on Cardiovascular Risk Factors
NCT01101230 · View on ClinicalTrials.gov ↗
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
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2009-09 |
| Est. Completion | 2012-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01101230
The ClinicalTrials.gov registry entry for NCT01101230 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Penn State University, which has 233 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01101230 reports 1 study location spanning 1 distinct geographic area — top geographies include Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01101230?
The interventions under investigation include: Almonds (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01101230?
This trial is sponsored by Penn State University, which has 233 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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