Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2026-01-05 @ 12:04 PM
Study NCT ID:
NCT02146157
Status:
COMPLETED
Last Update Posted:
2015-10-14
First Post:
2014-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of an Herb and Mineral Combination Product on Fasting Glucose in Adults at Risk for Developing Diabetes
Sponsor:
NewChapter, Inc.
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: