NCT00207272

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jul 2003

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

May 26, 2008

Status Verified

March 1, 2008

Enrollment Period

4.6 years

First QC Date

September 13, 2005

Last Update Submit

May 22, 2008

Conditions

Keywords

Hypocaloric MCT oil liquid dietHypocaloric LCT oil liquid dietVisceral and omental adipose tissueSubcutaneous abdominal adipose tissueGastric bypass surgery

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

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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: 7072620BACKGROUND
  • Guo 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: 10880345BACKGROUND
  • Geliebter 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: 6849272BACKGROUND
  • Bray 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: 7390698BACKGROUND
  • Han 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: 11983812BACKGROUND
  • Krotkiewski 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: 11571605BACKGROUND
  • Tsuji 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: 11694608BACKGROUND
  • Bendixen 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: 11756059BACKGROUND
  • Papamandjaris 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: 11033985BACKGROUND
  • St-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

ObesityWeight Loss

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Caroline Apovian, MD

    Boston University Medical Cneter

    PRINCIPAL INVESTIGATOR
  • 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 CHAIR

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

Locations