Ignite Creation Date:
2024-10-25 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06641596
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
Impact of Chromium Phyllanthus Emblica and Shilajit on Cardiovascular Health Fitness and Weight Loss During Exercise and Diet Programs
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Chromium Phyllanthus Emblica Fruit Extract and Shilajit Supplementation on Markers of Cardiovascular Health Fitness and Weight Loss in Men and Women Initiating an Exercise and Diet Intervention Program
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A randomized double-blind placebo controlled parallel study to determine if Chromium Cr Phyllanthus emblica PE and Shilajit SJ supplementation and Phyllanthus emblica fruit extract supplementation promotes greater changes in glucose homeostasis endothelial function and cardiometabolic risk in sedentary and overweight men and women initiating an exercise and weight loss program
Detailed Description:
Men and women with at least 2 markers of metabolic syndrome will participate in a randomized placebo-controlled parallel and repeated measures intervention trial Volunteers will participate in a standardized resistance training 3 sessionsweek and aerobic training 3 x 30 min sessionsweek program while reducing energy intake by 5 kcalskgd
In a double-blind and randomized manner participants will be matched by age sex BMI and body mass to supplement their diet with placebo PLA 400 mcg of trivalent chromium with 6 mg of PE and 6 mg of SJ Cr-400 or 800 mcg of trivalent chromium with 12 mg of PE and 12 mg of SJ Cr-800 or 500 mg of PE PE-500 or 1000 mg of PE PE-1000 once a day after breakfast for 12-weeks
Fasting blood samples DEXA body composition platelet aggregation and ultrasound flow-mediated dilation FMD studies will be conducted at 0 6 and 12 weeks of supplementation
In a double-blind and randomized manner participants will be matched by age sex BMI and body mass to supplement their diet with placebo PLA 400 mcg of trivalent chromium with 6 mg of PE and 6 mg of SJ Cr-400 or 800 mcg of trivalent chromium with 12 mg of PE and 12 mg of SJ Cr-800 or 500 mg of PE PE-500 or 1000 mg of PE PE-1000 once a day after breakfast for 12-weeks
Fasting blood samples DEXA body composition platelet aggregation and ultrasound flow-mediated dilation FMD studies will be conducted at 0 6 and 12 weeks of supplementation
Study Oversight
Has Oversight DMC:
None
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?:
None