Type 2 Diabetes Clinical Trial
Official title:
The Effect of Whey Protein and Dietary Fibers on Risk Markers of the Metabolic Syndrome and Bone Health
The prevalence of overweight and lifestyle related diseases such as cardiovascular disease
(CVD) and type 2 diabetes (T2D) is increasing world wide. The metabolic syndrome (MeS) is a
condition characterized by abdominal obesity, high blood lipids, high blood pressure and
elevated blood sugar. MeS is associated with an increased risk of developing CVD and T2D.
Dietary fibers and whey protein have independently shown beneficial effects on several of
these risk factors in previous studies. Whey protein is furthermore seen to show positive
effects on bone turnover.
The purpose of this trial is to investigate whether an increased intake of dietary fibers and
whey protein (separately or combined) over a period of 12 weeks will affect the risk markers
of MeS and bone turnover in abdominally obese subjects.
A total of 80 people with abdominal obesity will be included. The design is a randomized,
double blinded, controlled dietary intervention trial. Subjects are assigned to one of four
experimental groups. Each group are provided with test products containing either high or low
whey protein and high or low dietary fibers to replace part of their regular diet. The
subjects are instructed in how to incorporate the test products in their habitual diets in
order to maintain weight stability.
The primary outcome is postprandial lipaemia (PPL) - an independent risk factor of developing
CVD. PPL is estimated by performing a standardized high fat meal test during which
postprandial level of triglycerides is measured. The authors hypothesize that a diet of high
content of whey protein and high dietary fiber during 12 weeks will induce a reduction in
PPL.
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