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NCT00270985 · ClinicalTrials.gov registry record · Phase 1
The Metabolic Effects of Almond Consumption in Adults With Pre-Diabetes
A Phase 1 study, sponsored by University of Medicine and Dentistry of New Jersey.
- Completed
- Registry status
- Phase 1
- Development phase
- 66
- Enrollment target
NCT00270985 is a Phase 1 study that has completed, run by University of Medicine and Dentistry of New Jersey. The registered enrollment target is 66 participants.
The verdict
NCT00270985, a Phase 1 study, has completed, sponsored by University of Medicine and Dentistry of New Jersey.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 66 participants
- Enrollment target
Study Summary
Study Hypothesis: Daily consumption of almonds over 16 weeks will produce a decrease in hemoglobin A1c (HbA1c) levels in adults with pre-diabetes. Lay Summary: Persons developing type 2 diabetes mellitus (T2DM) will typically first have a condition called pre-diabetes. Lifestyle is a major factor that determines whether pre-diabetes becomes full T2DM. Lifestyle includes dietary habits and physical activity. Many people develop T2DM because of poor dietary habits and a sedentary lifestyle. Moreover, eating a high-fat, high-sugar diet can damage the blood vessels and increase the risk of strokes and heart attacks. A person's diet may produce substances in the blood that can interfere with the production of insulin in the pancreas. Sometimes, these changes in the insulin producing cells are serious and can eventually interfere with how the cells in the body use blood sugar, which causes T2DM. Techniques are available to measure circulating substances in the blood of persons with pre-diabetes that may be associated with the development of T2DM. Laboratory research has shown that almonds contain high levels of important compounds that may influence the onset of heart disease and T2DM. A meal plan that includes almonds daily will be given to half of the study participants and the other participants will be given a meal plan that is "nut-free". Because of the potential to delay the onset of heart disease and T2DM in some persons with pre-diabetes, this 16-week study will collect and analyze blood samples for changes that may make the person with pre-diabetes more likely to develop heart disease and T2DM. Blood samples will be collected at weeks 0, 8 and 16 to measure compounds that may be influenced by consuming almonds daily. This study will also attempt to understand other possible causes of heart disease and T2DM in persons with pre-diabetes; particularly those that might be related to body weight and body composition. Body composition techniques using very small amo
Interventions
- BEHAVIORAL Almonds in a calorie controlled diet
- BEHAVIORAL Nut free diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2006-01 |
| Est. Completion | 2016-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00270985
The ClinicalTrials.gov registry entry for NCT00270985 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Medicine and Dentistry of New Jersey, which has 88 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Almonds in a calorie controlled diet is the first listed.
NCT00270985 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00270985 about?
NCT00270985 is a clinical study titled "The Metabolic Effects of Almond Consumption in Adults With Pre-Diabetes". Study Hypothesis: Daily consumption of almonds over 16 weeks will produce a decrease in hemoglobin A1c (HbA1c) levels in adults with pre-diabetes. Lay Summary: Persons developing type 2 diabetes mellitus (T2DM) will typically first have a condition called pre-diabetes. Lifestyle is a major factor...
What is the current status of trial NCT00270985?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2006-01. Estimated completion is 2016-06.
What interventions are being tested in trial NCT00270985?
The interventions under investigation include: Almonds in a calorie controlled diet (BEHAVIORAL), Nut free diet (BEHAVIORAL).
Who is sponsoring clinical trial NCT00270985?
This trial is sponsored by University of Medicine and Dentistry of New Jersey, which has 88 total clinical trials registered on ClinicalTrials.gov.
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