This study was a double-blind, randomized, two-arm, placebo-controlled trial of apparently healthy men and women recruited at a single investigational center in Northeast Ohio (i.e. The Center for Applied Health Sciences).~Subjects will attend four study visits. During Visit 1, subjects will be screened for participation (i.e., medical history, physical exam, routine blood work [also HgA1c, insulin], background baseline diet). Over the next 12 weeks, subjects will attend Visits 2-4, wherein assessments of serum glucose, insulin, HOMA-IR, 2-hour glucose tolerance test (GTT), NMR profile, HgA1c, C-reactive protein, adiponectin, ferritin, waist circumference, quality of life questionnaire, and various visual analog scales for appetite, satiety, and cravings will be made (see Study Schematic for details).~Comprehensive side effect profile/ adverse event monitoring will take place throughout the study duration. The study will be conducted following ICH-GCP guidelines to ensure subject safety and scientific integrity of the data.
This study was a double-blind, randomized, placebo-controlled, clinical trial with two parallel groups. Participants reported to a single investigational center in Ohio (i.e., The Center for Applied Health Sciences) during the 12 week trial.