This study is a randomized, double-blind, placebo-controlled, dose-response study of BKR-017 and placebo that will be conducted at two investigative sites. The total duration of subject involvement is approximately 15 weeks; the screening period can be up to 3 weeks prior to the start of test period, followed by a 12-week test period. During the test period, subjects will self-administer three tablets of test product, two times daily: before breakfast and before bedtime.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
60
Nutrient butyrate into a colon-targeted tablet formulation (BKR-017) is intended to stimulate secretion of GLP-1 from L-cells in the lower gut. Butyrate delivered to the colon in tablet form will not cause the side-effects seen with formation of butyrate by fermentation.
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
Duke Clinical Research at Pickett Road
Durham, North Carolina, United States
Duke Clinical & Translational Science Institute (CTSI)
Kannapolis, North Carolina, United States
Changes in HOMA-IR
Changes in HOMA-IR at Days 21, 42, 63, and 84 using repeated measures ANCOVA
Time frame: Baseline, Day 1, during the treatment period at days 21, 42, and 63, and at end of treatment period, Day 84
Changes in fasting low-density lipoprotein-cholesterol (LDL-C)
Changes in fasting low-density lipoprotein-cholesterol (LDL-C) at Days 1, 42, and 84
Time frame: Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84
Changes in fasting triglycerides
Changes in fasting triglycerides at Days 1, 42, and 84
Time frame: Baseline, Day 1, during the treatment period at days 42, and at end of treatment period, Day 84
Changes in HbA1c
Changes in HbA1c at Days 1, 42, and 84
Time frame: Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84
Changes in fasting glucose
Changes in fasting glucose at Days 1, 42, and 84
Time frame: Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84
Changes in fasting insulin
Changes in fasting insulin at Days 1, 42, and 84
Time frame: Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84
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