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NCT01027325 · ClinicalTrials.gov registry record · NA
Resistant Starch Insulin Sensitivity Trial
A NA study, sponsored by UCSF Benioff Children's Hospital Oakland.
- Completed
- Registry status
- NA
- Development phase
- 52
- Enrollment target
NCT01027325: Completed NA study, sponsored by UCSF Benioff Children's Hospital Oakland.
NCT01027325 is a NA study that has completed, run by UCSF Benioff Children's Hospital Oakland. The registered enrollment target is 52 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01027325, a NA study, has completed, sponsored by UCSF Benioff Children's Hospital Oakland.
- COMPLETED
- Registry status
- NA
- Development phase
- 52 participants
- Enrollment target
Study Summary
The alarming increase in the prevalence of obesity is a cause of great concern given its association with many adverse health conditions, including insulin resistance and type 2 diabetes, which are associated with increased cardiovascular disease (CVD) risk. The primary objective of this project is to identify effective dietary strategies, focused on carbohydrate quantity and starch digestibility, to improve outcome variables associated with CVD risk in insulin resistant individuals who express components of the atherogenic lipoprotein phenotype (ALP). Current dietary guidelines emphasize substitution of carbohydrate calories for total and saturated fat calories for prevention and management of chronic disease. Yet, we and others have shown that high-carbohydrate diets increase the expression of the ALP, characterized by increased plasma triglycerides, reduced HDL cholesterol, and increased levels of small, dense LDL particles, and that this phenotype is reversed by moderate carbohydrate restriction. We have also shown that expression of stearoyl coenzymeA desaturase (SCD), an enzyme involved in triglyceride synthesis, is reduced with carbohydrate restriction and that this change is correlated with plasma triglyceride response. While carbohydrate restriction is effective for management of ALP, the role of starch quality has not been addressed. Furthermore, there has been no study of the effects of resistant vs. digestible starches incorporated into high- vs. lower carbohydrate diets. Since isolated reports suggest that increased intake of resistant starch lowers plasma triglycerides and postprandial insulinemia, we hypothesize that starch quality is an important determinant of components of ALP, and that this may be mediated in part by reduced adipose tissue SCD expression. Aim 1 and of this proposal will address this hypothesis by a controlled dietary intervention in 52 insulin resistant men and women in which changes in plasma lipids, lipoproteins and lipogenic ge
Interventions
- OTHER Dietary Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2010-06 |
| Est. Completion | 2012-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01027325
The ClinicalTrials.gov registry entry for NCT01027325 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UCSF Benioff Children's Hospital Oakland, which has 52 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Dietary Intervention is the first listed.
NCT01027325 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01027325 about?
NCT01027325 is a clinical study titled "Resistant Starch Insulin Sensitivity Trial". The alarming increase in the prevalence of obesity is a cause of great concern given its association with many adverse health conditions, including insulin resistance and type 2 diabetes, which are associated with increased cardiovascular disease (CVD) risk. The primary objective of this project is ...
What is the current status of trial NCT01027325?
This trial is currently completed. It is a NA study. The enrollment target is 52 participants. The study started on 2010-06. Estimated completion is 2012-11.
What interventions are being tested in trial NCT01027325?
The interventions under investigation include: Dietary Intervention (OTHER).
Who is sponsoring clinical trial NCT01027325?
This trial is sponsored by UCSF Benioff Children's Hospital Oakland, which has 52 total clinical trials registered on ClinicalTrials.gov.
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