Clinical trial NCT02146157: Trial of an Herb and Mineral Combination Product on Fasting Glucose in Adults at Risk for Developing Diabetes
Official title: A Randomized, Double-blind, Placebo-controlled Trial to Assess Efficacy and Tolerability of an Herb and Mineral Combination Product on Fasting Glucose in Adults at Risk for Developing Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetes
Lead sponsor: NewChapter, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Procter and Gamble
First posted: 2014-05-23
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: The target population of this clinical trial is otherwise healthy, pre-diabetic adults who present with impaired fasting glucose.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from Baseline in fasting blood glucose
timeFrame: Day 84
Secondary outcomes:
measure: Change from Baseline in fasting serum glucose
timeFrame: Day 42
measure: Change from Baseline in fasting blood glucose
timeFrame: Day 21
measure: Change from Baseline in HbA1c
timeFrame: Day 84
measure: Change from Baseline in fasting lipids
timeFrame: Day 84
measure: Change from Baseline in fasting lipids
timeFrame: Day 42
measure: Change from Baseline in fasting lipids
timeFrame: Day 21
measure: Change from Baseline in BMI
timeFrame: Day 84
measure: Change from Baseline in waist-to-hip ratio
timeFrame: Day 84
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Radiant Research
state: Illinois
city: Lexington
country: United States
facility: Central Kentucky Research Associates
state: Kentucky
city: Bingham Farms
country: United States
facility: Quest Research Institute
state: Michigan
city: Cincinnati
country: United States
facility: Radiant Research
state: Ohio
city: Dayton
country: United States
facility: Providence Health Partners Center for Clinical Research
state: Ohio
city: Greer
country: United States
facility: Mountain View Clinical Research
state: South Carolina
Study officials:
References: