NCT06641596

Impact of Chromium, Phyllanthus Emblica, and Shilajit on Cardiovascular Health, Fitness, and Weight Loss During Exercise and Diet Programs

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Kerry Group P.L.C · Industry
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

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 sessions/week) and aerobic training (3 x 30 min sessions/week) program while reducing energy intake by 5 kcals/kg/d. 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.

Conditions

• Overweight
• Metabolic Syndrome X

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Placebo	2 capsules of Placebo, once daily after breakfast for 12 weeks
DIETARY_SUPPLEMENT	Cr-400	1 capsule of Cr-400 + 1 capsule of Placebo, once a day after breakfast for 12 weeks
DIETARY_SUPPLEMENT	Cr-800	2 capsules of Cr-400, once a day after breakfast for 12 weeks
DIETARY_SUPPLEMENT	PE-500	1 capsule of PE + 1 capsule of Placebo, once a day after breakfast for 12 weeks
DIETARY_SUPPLEMENT	PE-1000	2 capsules of PE-500, once a day after breakfast for 12 weeks

Timeline

• Start date: 2019-02-01
• Primary completion: 2024-01-30
• Completion: 2024-05-29
• First posted: 2024-10-15
• Last updated: 2024-10-15

Locations

1 site across 1 country: United States