Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-24 @ 5:09 PM
Study NCT ID:
NCT05887050
Status:
COMPLETED
Last Update Posted:
2023-06-05
First Post:
2023-05-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of a Dietary Supplement Containing Salacia Extract, Citrus Bioflavonoids, and Trivalent Chromium on Markers of Glucose Control
Sponsor:
The Center for Applied Health Sciences, LLC
Organization:
Study Overview
Official Title:
Effects of a Dietary Supplement Containing Salacia Extract, Citrus Bioflavonoids, and Trivalent Chromium on Markers of Glucose Control and Quality of Life: A Randomized, Placebo-Controlled, Double-Blind Pilot Study
Status:
COMPLETED
Status Verified Date:
2023-06
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 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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: