This is a multi-center, randomized, double-blind, placebo-controlled study in approximately 104 subjects (52 per group) to evaluate the effectiveness of an herb and mineral combination product on fasting serum glucose levels in subjects with impaired fasting glucose. The study consists of 5 visits: a Screening visit, followed by a Baseline visit (at which eligible subjects will be randomized to product to consume throughout the 12-week supplementation period), followed by Supplementation period visits at 3, 6 and 12 weeks after baseline.
The target population of this clinical trial is otherwise healthy, pre-diabetic adults who present with impaired fasting glucose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
104
herb and mineral product containing cinnamon, turmeric and holy basil
Placebo of herb and mineral product containing cinnamon, turmeric and holy basil
Radiant Research
Chicago, Illinois, United States
Central Kentucky Research Associates
Lexington, Kentucky, United States
Quest Research Institute
Bingham Farms, Michigan, United States
Radiant Research
Cincinnati, Ohio, United States
Change from Baseline in fasting blood glucose
Fasting glucose will be measured on serum samples obtained at screening (to be used as baseline value) and at day 84
Time frame: Day 84
Change from Baseline in fasting serum glucose
Fasting glucose will be measured on serum samples obtained at screening (to be used as baseline value) and at day 42
Time frame: Day 42
Change from Baseline in fasting blood glucose
Fasting glucose will be measured on serum samples obtained at screening (to be used as baseline value) and at day 21
Time frame: Day 21
Change from Baseline in HbA1c
Glycosylated hemoglobin (HbA1c) will be measured on whole blood samples obtained at screening and at day 84.
Time frame: Day 84
Change from Baseline in fasting lipids
Total cholesterol, high-density lipoprotein, low-density lipoprotein, very low-density lipoprotein, and triglycerides will be measured on serum samples obtained at screening and at day 84 using a standard lipid panel.
Time frame: Day 84
Change from Baseline in fasting lipids
Total cholesterol, high-density lipoprotein, low-density lipoprotein, very low-density lipoprotein, and triglycerides will be measured on serum samples obtained at screening and at day 42 using a standard lipid panel.
Time frame: Day 42
Change from Baseline in fasting lipids
Total cholesterol, high-density lipoprotein, low-density lipoprotein, very low-density lipoprotein, and triglycerides will be measured on serum samples obtained at screening and at day 21 using a standard lipid panel.
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Providence Health Partners Center for Clinical Research
Dayton, Ohio, United States
Mountain View Clinical Research
Greer, South Carolina, United States
Time frame: Day 21
Change from Baseline in BMI
Body mass index
Time frame: Day 84
Change from Baseline in waist-to-hip ratio
Time frame: Day 84