Use of MCT Oil for Enhancement of Weight Loss and Glycemic Control in Obese Diabetic Patients
Condition: Obesity; Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2; Weight Loss
Study type: Interventional
Phase: Phase 1/Phase 2

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      5% of their baseline weight by the end of Phase I will be withdrawn from the study.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).
    

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 mg/dl) 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 (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 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 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 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, 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).
    

Intervention name(s): MCT oil hypocaloric liquid diet; LCT hypocaloric liquid diet; Subcutaneous abdominal adipose tissue biopsy
Intervention type(s): Behavioral; Behavioral; Procedure
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Weight loss; MCT oil hypocaloric liquid diet; LCT oil hypocaloric liquid diet; Gastric Bypass