Herbal Preparation and Glucose Homeostasis
Herbal Preparation and Glucose Homeostasis
NCT ID: NCT02065271 Phase: NA Status: COMPLETED Enrollment: 22 Completion: 2014-02
Conditions
Glucose Tolerance, Lipid Homeostasis, Vascular Function, Inflammation
Interventions
herbal supplement, placebo supplement
Summary
Rationale: The incidence of obesity and type 2 diabetes (T2D) is increasing rapidly and accounts for a considerable part of health care costs. Herbal supplements are used in many cultures for the prevention and treatment of many different conditions. Due to lack of scientific proof, the application in western cultures are minimal. Animal studies have shown that many constituents of such herbal supplements may have beneficial effects on several important parameters known to be affected in T2D. Still, no scientific proof in humans is available. We therefore aim to investigate the effect of 4-week herbal supplementation on glucose metabolism, lipid metabolism, vascular function and inflammation in subjects with increased fasting glucose levels or a decreased glucose tolerance.
Objective: The primary objectives are to investigate if 4-week herbal supplementation in subjects with increased fasting glucose levels or a decreased glucose tolerance has a positive effect on blood glucose levels and glucose tolerance. The secondary objectives are to investigate if 4-week herbal supplementation in subjects with increased fasting glucose levels or a decreased glucose tolerance has a positive effect on triglycerides (TG), total cholesterol (TC), low density lipoprotein (LDL), high density lipoprotein (HDL) levels, inflammation, adipose tissue and white blood cell gene-expression and AIX both fasted and during an OGTT test.
Study design: This study is a randomized, double-blind, placebo controlled cross-over trial in which two different treatments will be evaluated e.g. an intervention with the herbal mixture and a placebo. Each person will obtain both treatments in random order for four weeks with a wash out period of four weeks in-between. Fasting blood samples will be collected and subjects will receive a OGTT, paralleled by a PWA before and after 4-week supplementation.
Furthermore, after 4-week supplement intake we will collect a urine sample and collect an adipose tissue
Primary Outcome
change in glucose tolerance