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NCT00207272 · ClinicalTrials.gov registry record · NA
Use of MCT Oil for Enhancement of Weight Loss in Obese Patients
A NA study, sponsored by Boston Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 24
- Enrollment target
NCT00207272 is a NA study that has completed, run by Boston Medical Center. The registered enrollment target is 24 participants.
The verdict
NCT00207272, a NA study, has completed, sponsored by Boston Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
Study Summary
Twelve obese patients approved for gastric bypass surgery will be randomized to either receive an MCT-based or LCT-based liquid diet for a 4 week period. These diets will be identical except for the quality of the fat. The intervention will be double-blinded. Six patients will receive a daily diet consisting of 5 liquid meals using the HMR 800 meal replacement product (Health Management Resources, Inc; 160 calories/shake) with 44.5 grams MCT oil (Life Enhancement Products, Inc., Petaluna, CA; 8.3 kcal/gm) added. Six patients will receive the same HMR diet but with 41 grams LCT oil (corn oil; 9 kcal/gm) added. 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 700 kcal per day from this list and will be asked to complete food records for monitoring of their caloric intake. Patients will undergo gastric bypass surgery after 4 weeks of being on their diets. Patients in both groups will be seen weekly by a registered dietitian and a physician. Blood pressure and weight will be recorded, and any adverse events will be noted and cared for as is appropriate. Dietary instruction will be reviewed as needed.Both diets will be 1170-1870 kcal/day, consisting of 36% CHO, 26.2% protein, and 37.6% fat. The MCT diet will contain 30.2% of total calories at MCT oil. The percentages given are based on the shake and oil consumption only (1170 kcal/day). The remainder of the diet will vary according to patients' selections from the list of permitted foods, up to an additional 700 kcal/day (for the total 1870 kcal/day). All subjects will receive a multi-vitamin each day. Subjects will also receive two Fibercon capsules per day to prevent possible bowel changes associated with being on a full liquid diet. During surgery, biopsies of visceral and omental adipose tissue, as well as subcutaneous abdominal adipose tissue, will be obtained. Tissue will be analyzed to determine mRNA levels of key enzymes
Interventions
- PROCEDURE Gastric bypass surgery
- BEHAVIORAL 1170-1870 kcal/day liquid diet
- PROCEDURE Biopsy.visceral adipose tissue
- PROCEDURE Biopsy.omental adipose tissue
- PROCEDURE Biopsy. subcutaneous abdominal adipose tissue
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2003-07 |
| Est. Completion | 2008-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00207272
The ClinicalTrials.gov registry entry for NCT00207272 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. 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 5 interventions - of which Gastric bypass surgery is the first listed.
NCT00207272 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00207272 about?
NCT00207272 is a clinical study titled "Use of MCT Oil for Enhancement of Weight Loss in Obese Patients". Twelve obese patients approved for gastric bypass surgery will be randomized to either receive an MCT-based or LCT-based liquid diet for a 4 week period. These diets will be identical except for the quality of the fat. The intervention will be double-blinded. Six patients will receive a daily diet c...
What is the current status of trial NCT00207272?
This trial is currently completed. It is a NA study. The enrollment target is 24 participants. The study started on 2003-07. Estimated completion is 2008-02.
What interventions are being tested in trial NCT00207272?
The interventions under investigation include: Gastric bypass surgery (PROCEDURE), 1170-1870 kcal/day liquid diet (BEHAVIORAL), Biopsy.visceral adipose tissue (PROCEDURE), Biopsy.omental adipose tissue (PROCEDURE), Biopsy. subcutaneous abdominal adipose tissue (PROCEDURE).
Who is sponsoring clinical trial NCT00207272?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
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