Use of MCT Oil for Enhancement of Weight Loss in Obese Patients
1 other identifier
interventional
24
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Jul 2003
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedMay 26, 2008
March 1, 2008
4.6 years
September 13, 2005
May 22, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Boston University Medical Center
Boston, Massachusetts, 02118, United States
Related Publications (10)
Baba N, Bracco EF, Hashim SA. Enhanced thermogenesis and diminished deposition of fat in response to overfeeding with diet containing medium chain triglyceride. Am J Clin Nutr. 1982 Apr;35(4):678-82. doi: 10.1093/ajcn/35.4.678.
PMID: 7072620BACKGROUNDGuo W, Choi JK, Kirkland JL, Corkey BE, Hamilton JA. Esterification of free fatty acids in adipocytes: a comparison between octanoate and oleate. Biochem J. 2000 Jul 15;349(Pt 2):463-71. doi: 10.1042/0264-6021:3490463.
PMID: 10880345BACKGROUNDGeliebter A, Torbay N, Bracco EF, Hashim SA, Van Itallie TB. Overfeeding with medium-chain triglyceride diet results in diminished deposition of fat. Am J Clin Nutr. 1983 Jan;37(1):1-4. doi: 10.1093/ajcn/37.1.1.
PMID: 6849272BACKGROUNDBray GA, Lee M, Bray TL. Weight gain of rats fed medium-chain triglycerides is less than rats fed long-chain triglycerides. Int J Obes. 1980;4(1):27-32.
PMID: 7390698BACKGROUNDHan J, Farmer SR, Kirkland JL, Corkey BE, Yoon R, Pirtskhalava T, Ido Y, Guo W. Octanoate attenuates adipogenesis in 3T3-L1 preadipocytes. J Nutr. 2002 May;132(5):904-10. doi: 10.1093/jn/132.5.904.
PMID: 11983812BACKGROUNDKrotkiewski M. Value of VLCD supplementation with medium chain triglycerides. Int J Obes Relat Metab Disord. 2001 Sep;25(9):1393-400. doi: 10.1038/sj.ijo.0801682.
PMID: 11571605BACKGROUNDTsuji H, Kasai M, Takeuchi H, Nakamura M, Okazaki M, Kondo K. Dietary medium-chain triacylglycerols suppress accumulation of body fat in a double-blind, controlled trial in healthy men and women. J Nutr. 2001 Nov;131(11):2853-9. doi: 10.1093/jn/131.11.2853.
PMID: 11694608BACKGROUNDBendixen H, Flint A, Raben A, Hoy CE, Mu H, Xu X, Bartels EM, Astrup A. Effect of 3 modified fats and a conventional fat on appetite, energy intake, energy expenditure, and substrate oxidation in healthy men. Am J Clin Nutr. 2002 Jan;75(1):47-56. doi: 10.1093/ajcn/75.1.47.
PMID: 11756059BACKGROUNDPapamandjaris AA, White MD, Raeini-Sarjaz M, Jones PJ. Endogenous fat oxidation during medium chain versus long chain triglyceride feeding in healthy women. Int J Obes Relat Metab Disord. 2000 Sep;24(9):1158-66. doi: 10.1038/sj.ijo.0801350.
PMID: 11033985BACKGROUNDSt-Onge MP, Jones PJ. Physiological effects of medium-chain triglycerides: potential agents in the prevention of obesity. J Nutr. 2002 Mar;132(3):329-32. doi: 10.1093/jn/132.3.329.
PMID: 11880549BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
July 1, 2003
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
May 26, 2008
Record last verified: 2008-03