This study will critically evaluate the effects of a novel dietary fiber administered to subjects at high risk for developing diabetes to determine if this intervention will improve insulin sensitivity compared to control product administration and, thus, decrease risk for developing diabetes. The hypothesis is that consuming this novel fiber twice a day for 12 weeks will significantly decrease fasting plasma glucose, insulin and glycosylated hemoglobin values in pre-diabetic subjects (i.e. subjects with fasting plasma glucose levels 95-140 mg/dl at screening) compared to consumption of the control product.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
60
oral consumption in beverage
oral consumption in beverage
oral consumption in beverage
Louisville Metabolic and Atherosclerosis Research Center (LMARC)
Louisville, Kentucky, United States
Mean changes in fasting and post-glucose administration values for plasma glucose from baseline to end of study
Time frame: 0 weeks, 6 weeks, 9 weeks,12 weeks
Mean changes in fasting and post-glucose administration values for plasma insulin from baseline to end of study
Time frame: 0 weeks, 6 weeks, 9 weeks,12 weeks
Mean changes in blood HbA1c values from baseline to end of study
Time frame: 0 weeks, 12 weeks
Mean changes from baseline to end of study in HOMA, a measure of insulin sensitivity
Time frame: 0 weeks, 6 weeks, 9 weeks,12 weeks
Mean changes from baseline for fasting serum total cholesterol, HDL-cholesterol, LDL-cholesterol and triglyceride values at 6 and 12 weeks
Time frame: 0 weeks, 6 weeks, 12 weeks
Percentage change and absolute change from baseline in body weight at each treatment visit
Time frame: 0 weeks, 3 weeks, 6 weeks, 9 weeks, 12 weeks
Mean changes from baseline in waist circumference at selected visits
Time frame: 0 weeks, 12 weeks
Mean changes in total body fat, lean tissue and abdominal fat as determined by DEXA [distribution or absolute changes]
Time frame: 0 weeks, 12 weeks
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