Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
NewChapter, Inc.
With
Procter and Gamble
The target population of this clinical trial is otherwise healthy, pre-diabetic adults who present with impaired fasting glucose.
Age
18–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Be male or female, at least 18 years of age
If age ≥45 years, must have a body mass index ≥ 25 kg/m2
If age \<45 years, must have a body mass index ≥ 25 kg/m2 AND present with at least one additional risk factors for developing diabetes.
Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (women only)
Be able to understand the nature and purpose of the study including potential risks and side effects
Be willing to consent to study participation and to comply with study requirements
Have a finger stick fasting blood glucose between 105 and 140 mg/dL and a serum fasting glucose between 100 and 125 mg/dL, measured at screening
You may not be if
Have diabetes (type I or II) or an HBA1c measurement \>6.5% at any time in the past or at the screening visit
Have been taking within 2 weeks of screening any dietary supplement including vitamin and mineral complexes; herbal supplements; fish oil; fiber supplements; or any herbal ingredient/product that significantly affects glucose metabolism
Have been taking within 4 weeks of screening any prescription or over-the-counter (OTC) medication that significantly affects glucose metabolism, including but not limited to, sulfonylureas, meglitinides, biguanides, thiazolidinediones, alpha-glucosidase inhibitors, Inhibitors of dipeptidyl peptidase 4 (DPP-4 inhibitors), systemic corticosteroids
Daily use of non-steroidal anti-inflammatory drugs (NSAIDS) (daily baby aspirin use and continuous use of NSAIDS for 3 days or less for acute aches and pains are acceptable)
Any co-morbidity or treatment that could, in the opinion of the investigator, preclude the subject's ability to successfully and safely complete the study or that may confound study outcomes
Anticipated changes in dietary patterns or physical activity levels during the study, including attempts at body weight reduction
Eating disorder
Polycystic ovary syndrome
Known allergies or intolerance to any substance in the study product
Are pregnant or breastfeeding women
History of alcohol, drug, or medication abuse
Have participated in another study with any investigational product within 1 month of screening
Had a recent (\<3 months) gastrointestinal surgery or any planned surgery during the clinical study
Clareo Health | Trial of an Herb and Mineral Combination Product on Fasting Glucose in Adults at Risk for Developing Diabetes
