Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00207233
Status:
COMPLETED
Last Update Posted:
2011-01-25
First Post:
2005-09-14
Brief Title:
Use of MCT Oil for Enhancement of Weight Loss and Glycemic Control in Obese Diabetic Patients
Sponsor:
Boston Medical Center
Organization:
Boston Medical Center
Study Overview
Official Title:
Use of MCT Oil for Enhancement of Weight Loss and Glycemic Control in Obese Diabetic Patients 2002-292G
Status:
COMPLETED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase I 6 weeks Intensive weight loss 42 obese subjects with type 2 diabetes mellitus or impaired fasting glucose FBS greater than 100 mgdl 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 kcalday 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 83 kcalgm added per day to the HMR shakes The LCT diet will utilize 5 HMR shakes plus 315 grams LCT oil corn oil 9 kcalgm 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adipose tissue biopsy blood work Subjects who do not lose 5 of their baseline weight by the end of Phase I will be withdrawn from the study If subjects do not lose 5 in Phase I they will be considered inappropriate for a liquid diet and therefore for the study and will be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
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
Detailed Description:
Phase I 6 weeks Intensive weight loss forty-two obese subjects with type 2 diabetes mellitus or impaired fasting glucose FBS greater than 100 mgdl 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 kcalday 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 HMR 800 Health Management Resources Inc 160 kcalshake plus 34 grams MCT oil Life Enhancement Products Inc Petaluna CA 83 kcalgm added per day to the HMR shakes The LCT diet will utilize 5 HMR shakes plus 315 grams LCT oil corn oil 9 kcalgm 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 of walking for 30 minutes five times per week Participants will complete food and exercise logs that will be analyzed by the study staff Baseline testing includes the following Body composition by DEXA Hologic Subcutaneous abdominal adipose tissue biopsy blood for CBC basic metabolic panel LFT TSH C-reactive protein HOMA-IR fasting glucose insulin lipids total cholesterol HDL LDL triacyglycerol hemoglobin A1c hydroxybutyrate free fatty acids leptin adiponectin TNF-alpha and PAI-1 For measuring dietary compliance throughout the entire study three consecutive daily dietary records two week day and one weekend day will be analyzed each week by a registered dietitian using the Minnesota Nutrient Database Subjects who do not lose 5 body 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 programOnce 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 the following data will be collected Lab data CBC basic metabolic panel LFT TSH C-reactive protein fasting blood glucose insulin HOMA-IR lipids total cholesterol HDL LDL triacyglycerol HbA1c hydroxybutyrate FFA leptin adiponectin TNF-alpha and PAI-1 levels 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
Phase II 6 weeks Continued weight loss program During phase II subjects will be maintained on the same diet supplements and exercise programOnce 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 the following data will be collected Lab data CBC basic metabolic panel LFT TSH C-reactive protein fasting blood glucose insulin HOMA-IR lipids total cholesterol HDL LDL triacyglycerol HbA1c hydroxybutyrate FFA leptin adiponectin TNF-alpha and PAI-1 levels 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None