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NCT01792648 · ClinicalTrials.gov registry record · NA
Effects of Almond Intake on Atherogenic Lipoprotein Particles
A NA study of Dyslipidemia and Obesity, Abdominal, sponsored by UCSF Benioff Children's Hospital Oakland.
- Completed
- Registry status
- NA
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT01792648 is a NA study of Dyslipidemia and Obesity, Abdominal that has completed, run by UCSF Benioff Children's Hospital Oakland. The registered enrollment target is 24 participants, below the 362-participant average among 40 other Dyslipidemia trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01792648, a NA study of Dyslipidemia and Obesity, Abdominal, has completed, sponsored by UCSF Benioff Children's Hospital Oakland.
- COMPLETED
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
Increased abdominal adiposity is a key feature of metabolic syndrome, which describes a cluster of cardiovascular disease (CVD) risk factors that also includes insulin resistance, high blood pressure and an atherogenic lipoprotein phenotype characterized by increased plasma triglycerides, low HDL-C, and increased levels of small LDL particles. While lifestyle intervention remains the cornerstone for managing obesity and metabolic syndrome, the optimal dietary macronutrient distribution for improving blood lipids and CVD risk remains a topic of controversy. While both low carbohydrate diets and weight reduction are effective for managing atherogenic dyslipidemia, long-term compliance is low, and it becomes imperative to identify alternative dietary approaches. Increased consumption of almonds has been shown to lower LDL-C, an effect that exceeds that predicted from changes in fatty acid intake. However, although LDL-C lowering by almonds has been demonstrated in patients with diabetes, there have been no trials in non-diabetic patients with abdominal obesity. Moreover, there is limited information of the effects of almond intake on LDL particle subclasses. The overall objective of the present study is to determine whether lipoprotein measures of CVD risk in individuals with increased abdominal adiposity are reduced by almond supplementation in a diet with overall macronutrient content that conforms to current guidelines. Our main hypothesis is that in these individuals, almond consumption can reduce levels of small and medium LDL particles without the need to restrict dietary carbohydrates to levels below those currently recommended. This hypothesis will be tested by comparing the lipoprotein effects of an almond-supplemented diet (20%E) with those of two reference diets that do not contain almond products: one with similar content of carbohydrate, protein, and fat (standard reference), and the other in which carbohydrate content is reduced by substitution of prot
Conditions Studied
Interventions
- OTHER Standard reference diet
- OTHER Almond supplemented diet
- OTHER Low carbohydrate reference diet
Study Locations (1)
California
- Cholesterol Research Center - Berkeley
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2013-04 |
| Est. Completion | 2016-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01792648
The ClinicalTrials.gov registry entry for NCT01792648 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 362-participant average among 40 other Dyslipidemia trials with a reported enrollment target (93% lower). The listed sponsor is UCSF Benioff Children's Hospital Oakland, which has 52 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Dyslipidemia appearing as the primary indexed condition, and to 3 interventions - of which Standard reference diet is the first listed.
NCT01792648 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT01792648 about?
NCT01792648 is a clinical study titled "Effects of Almond Intake on Atherogenic Lipoprotein Particles". Increased abdominal adiposity is a key feature of metabolic syndrome, which describes a cluster of cardiovascular disease (CVD) risk factors that also includes insulin resistance, high blood pressure and an atherogenic lipoprotein phenotype characterized by increased plasma triglycerides, low HDL-C,...
What is the current status of trial NCT01792648?
This trial is currently completed. It is a NA study. The enrollment target is 24 participants. The study started on 2013-04. Estimated completion is 2016-04.
What conditions does trial NCT01792648 study?
This clinical trial studies the following conditions: Dyslipidemia, Obesity, Abdominal.
What interventions are being tested in trial NCT01792648?
The interventions under investigation include: Standard reference diet (OTHER), Almond supplemented diet (OTHER), Low carbohydrate reference diet (OTHER).
Who is sponsoring clinical trial NCT01792648?
This trial is sponsored by UCSF Benioff Children's Hospital Oakland, which has 52 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01792648 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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