Inflammation Clinical Trial
Official title:
Herbal Preparation and Glucose Homeostasis
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 biopsy. The whole trial will last three months.
Study population: 26 overweight males and females 50-75yrs old with an increased fasting
glucose or with an impaired glucose tolerance.
Intervention: Two intervention periods of 4-weeks in which participants will take three
times a day a supplement of 500mg herbal or placebo.
Main study parameters/endpoints: Fasting blood glucose levels, glucose tolerance as
determined by an oral glucose tolerance test (OGTT), AIX, triglycerides (TG), total
cholesterol (TC), low density lipoprotein (LDL), high density lipoprotein (HDL) levels, PWA,
adipose tissue an white blood cell gene expression and markers of inflammation .
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: Subjects that will participate in the study will invest a total of 16.5 hours.
Blood collection by vena punctures/insertion of the venflon and the collection of an adipose
tissue biopsy can occasionally cause a local hematoma or bruise and some participants may
report pain or discomfort. The herbal supplements contain small amounts St. John's wort,
which may affect the function of liver enzymes. We will therefore monitor liver function
parameters during the supplementation period. Furthermore, subjects are excluded if they use
medication known to be affected by St. John's wort. Participant will donate 284ml of blood,
dispersed over 12 weeks.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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