Use of MCT Oil for Enhancement of Weight Loss in Obese Patients

This study has been completed.
Sponsor:
Information provided by:
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00207272
First received: September 13, 2005
Last updated: May 22, 2008
Last verified: March 2008
  Purpose

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 in fatty acid esterification, lipolysis, and oxidative disposition. This preliminary phase will be conducted to determine whether visceral, omental, and subcutaneous abdominal adipose tissue behave similarly when exposed to an MCT-based diet.


Condition Intervention
Obesity
Weight Loss
Behavioral: 1170-1870 kcal/day liquid diet
Procedure: Gastric bypass surgery
Procedure: Biopsy.visceral adipose tissue
Procedure: Biopsy.omental adipose tissue
Procedure: Biopsy. subcutaneous abdominal adipose tissue
Procedure: Blood sample

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Use of MCT Oil for Enhancement of Weight Loss in Obese Patients-Preliminary Phase 2002-291G

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • To determine if the influence that MCFA have on the expression of genes that modulate lipid metabolism in adipose tissue is the same regardless of adipose fat depot

Estimated Enrollment: 24
Study Start Date: July 2003
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Approved for gastric bypass surgery
  • Age: 18-65 years
  • Gender: Male and female
  • BMI: >40 kg/m2 or >35 kg/m2
  • Obesity associated co-morbidities
  • Race: All

Exclusion Criteria:

  • Those that are a part of the normal standard of care in the pre-selection process for approval of surgery
  • Clinically severe lactose intolerance
  • Alcohol dependence
  • Egg allergy.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00207272

Locations
United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: Caroline Apovian, MD Boston University Medical Cneter
Study Chair: Sherman Bigornia Boston University
Study Chair: James Kirkland, MD,PhD Boston University
Study Chair: Peter Burke, MD Boston University
Study Chair: Wen Guo, PhD Boston University
Study Chair: Robert Forse, MD Boston University
Study Chair: Diana Cullum-Dugan, RD,LD Boston University
Study Chair: Donald Hess Boston University
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00207272     History of Changes
Other Study ID Numbers: H-24641
Study First Received: September 13, 2005
Last Updated: May 22, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Boston Medical Center:
Hypocaloric MCT oil liquid diet
Hypocaloric LCT oil liquid diet
Visceral and omental adipose tissue
Subcutaneous abdominal adipose tissue
Gastric bypass surgery

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on September 14, 2014