NCT02146157

Trial of an Herb and Mineral Combination Product on Fasting Glucose in Adults at Risk for Developing Diabetes

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: NewChapter, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Prediabetes

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	herb and mineral combination product	herb and mineral product containing cinnamon, turmeric and holy basil
DIETARY_SUPPLEMENT	Placebo	Placebo of herb and mineral product containing cinnamon, turmeric and holy basil

Timeline

• Start date: 2013-02-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2014-05-23
• Last updated: 2015-10-14

Locations

6 sites across 1 country: United States