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NCT00207233 · ClinicalTrials.gov registry record · Phase 1
Use of MCT Oil for Enhancement of Weight Loss and Glycemic Control in Obese Diabetic Patients
A Phase 1 study, sponsored by Boston Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
NCT00207233 is a Phase 1 study that has completed, run by Boston Medical Center. The registered enrollment target is 42 participants.
The verdict
NCT00207233, a Phase 1 study, has completed, sponsored by Boston Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
Study Summary
Phase I, 6 weeks: Intensive weight loss 42 obese subjects with type 2 diabetes mellitus or impaired fasting glucose (FBS greater than 100 mg/dl) and a patient at the Nutrition and Weight Management Center at Boston Medical Center will be randomized to receive either an MCT-based or LCT-based liquid diet for a 6 week period (Phase I) to establish compliance followed by a second 6 week period (Phase II). These diets will be isocaloric (1083 kcal/day) and identical except for the quality of the fat. The intervention will be double blinded. The MCT diet will consist of 5 liquid meals using a commercial product plus 34 grams MCT oil (Life Enhancement Products, Inc. Petaluna, CA; 8.3 kcal/gm) added per day to the HMR shakes. The LCT diet will utilize 5 HMR shakes plus 31.5 grams LCT oil (corn oil; 9 kcal/gm) per day. Patients in both groups will be given a list of supplemental foods that are suitable for the study. They may choose to eat up to an additional 400 kcal per day from this list and will be asked to add these to their food records for monitoring of their caloric intake. A dietitian will instruct subjects at a baseline visit on behavior modification and a moderate physical activity program. Baseline testing includes the following: Body composition by DEXA (Hologic); Subcutaneous abdominal adipose tissue biopsy; blood work. Subjects who do not lose 5% of their baseline weight by the end of Phase I will be withdrawn from the study. If subjects do not lose 5% in Phase I, they will be considered inappropriate for a liquid diet, and therefore for the study, and will be discontinued from the study. Phase II, 6 weeks: Continued weight loss program during phase II, subjects will be maintained on the same diet, supplements and exercise program. Once patients enter Phase II, all baseline lab measurements will be repeated. Needle biopsies of subcutaneous abdominal adipose tissue will be obtained at the beginning and at at the end of Phase II. Finger-stick blood glucose lev
Interventions
- BEHAVIORAL MCT oil hypocaloric liquid diet
- BEHAVIORAL LCT hypocaloric liquid diet
- PROCEDURE Subcutaneous abdominal adipose tissue biopsy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2004-07 |
| Est. Completion | 2009-07 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00207233
The ClinicalTrials.gov registry entry for NCT00207233 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Medical Center, which has 253 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which MCT oil hypocaloric liquid diet is the first listed.
NCT00207233 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00207233 about?
NCT00207233 is a clinical study titled "Use of MCT Oil for Enhancement of Weight Loss and Glycemic Control in Obese Diabetic Patients". Phase I, 6 weeks: Intensive weight loss 42 obese subjects with type 2 diabetes mellitus or impaired fasting glucose (FBS greater than 100 mg/dl) and a patient at the Nutrition and Weight Management Center at Boston Medical Center will be randomized to receive either an MCT-based or LCT-based liquid ...
What is the current status of trial NCT00207233?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2004-07. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00207233?
The interventions under investigation include: MCT oil hypocaloric liquid diet (BEHAVIORAL), LCT hypocaloric liquid diet (BEHAVIORAL), Subcutaneous abdominal adipose tissue biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT00207233?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
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