At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Use of MCT Oil for Enhancement of Weight Loss and Glycemic Control in Obese Diabetic Patients 2002-292G
In Brief
A Phase 2 clinical trial evaluating MCT oil hypocaloric liquid diet, LCT hypocaloric liquid diet, and 1 other intervention for Obesity and Type 2 Diabetes Mellitus. Completed, enrolled 42 participants across 1 site.
Detailed 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 Subjects who do not lose 5% of their baseline weight by the end of Phase I will be withdrawn from the study.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 levels will be checked weekly. At the end of Phase II, and of the study, fasting blood work will be obtained. At the end of Phase II, the following procedures will be performed: Subcutaneous abdominal adipose tissue biopsy (total = 3). Body composition by DEXA (Hologic) (total = 2).
Study Details
Timeline
Interventions
The MCT diet will consist of 5 liquid meals using a commercial product (HMR 800 Health Management Resources, Inc.; 160 kcal/shake) plus 34 grams MCT oil (Life Enhancement Products, Inc. Petaluna, CA; 8.3 kcal/gm) added per day to the HMR shakes. The intervention will last 3 months. After the first 6 weeks you will be assessed for 5% weight loss. If reach this weight change you will continue on the same intervention for another 6 weeks. Those who do not lose 5% of their baseline weight will be withdrawn from the study.
The LCT diet will consist of 5 liquid meals using a commercial product (HMR 800 Health Management Resources, Inc.; 160 kcal/shake) plus 31.5 grams LCT oil (corn oil; 9 kcal/gm) per day. Both diets will be isocaloric (1083 kcal/day) consisting of 38% CHO, 28% pro, 34% fat. The intervention will last 3 months. After the first 6 weeks you will be assessed for 5% weight loss. If reach this weight change you will continue on the same intervention for another 6 weeks. Those who do not lose 5% of their baseline weight will be withdrawn from the study.
Subcutaneous adipose tissue biopsies from human subjects will provide tissue samples for ex vivo analysis of adipocytokine production and cell size. Subcutaneous adipose tissue will be sampled by needle biopsy at the suprailiac crest skinfold using standard sterile technique. After a 10 cm area is isolated, cleaned and anesthetized with 1% lidocaine, a small cutaneous incision (1 cm) will be performed. A 50 cc syringe with a 19-gauge needle will be used to aspirate approximately 150 mg of adipose tissue which will require 2 to 6 passes of the needle. Sutures will be used to close the skin incision and a dry sterile dressing applied. This will be performed at baseline, 6 weeks, and 12 weeks.