This 12-week controlled diet and weight intervention study seeks to define the molecular pathways that link excess body weight to the development of insulin resistance (IR). Blood, adipose and stool are sampled at three timepoints; baseline, peak weight (4 weeks) and post weight loss to monitor changes in cellular processes. Additionally, direct insulin sensitivity testing, and radiological measurement of visceral fat and intrahepatic fat content is measured at three timepoints to correlate clinical indices with cellular changes.
Age 35-65
BMI 25-35 kg/m2
Stable body weight
Nondiabetic
diabetes
major organ disease
history of liposuction or bariatric surgery
active eating or psychiatric disorder
Parallel
Dietary Intervention Mediterranean Low Carbohydrate Diet
BehavioralAssigned participants will receive instruction by a registered dietitian on a diet that is high in unsaturated fats and low in carbohydrates. Total caloric intake will be adjusted to induce a supervised metabolic challenge defined as weight gain of approximately 2.5 kg over 5 weeks followed by 3-5kg weight loss over 8 weeks.
Dietary Intervention Standard Low Carbohydrate Diet
BehavioralAssigned participants will receive instruction by a registered dietitian on a low carbohydrate diet that is high in fats found in the typical American diet. Total caloric intake will be adjusted to induce a supervised metabolic challenge defined as weight gain of approximately 2.5 kg over 5 weeks followed by 3-5kg weight loss over 8 weeks.
Dietary Intervention Standard Low Fat Diet
BehavioralAssigned participants will receive instruction by a registered dietitian on a low fat diet that is high in complex carbohydrates. Total caloric intake will be adjusted to induce a supervised metabolic challenge defined as weight gain of approximately 2.5 kg over 5 weeks followed by 3-5kg weight loss over 8 weeks.
Change from baseline on the 2-stage Steady State Plasma Glucose test
Compare direct measurement of insulin sensitivity after 4 week diet and weight intervention
Change from baseline on the radiographic measurement of visceral to subcutaneous (V:S) fat ratio
Compare measurement of abdominal V:S fat volume via computed tomography (CT) after 4 week diet and weight intervention
Change from baseline on the magnetic-resonance based measurement of intrahepatic lipid deposition
Compare measurement of liver fat content via magnetic resonance spectroscopy (MRS) after 4 week diet and weight intervention
Change from peak weight on the 2-stage Steady State Plasma Glucose test
Compare direct measurement of insulin sensitivity after 8 week diet and weight intervention
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Stanford University
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
