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

Completed · Not applicable · Has a placebo group

Conditions studied: Overweight, Metabolic Syndrome X

In brief

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.

Key facts

Study ID

NCT06641596

Run by

Kerry Group P.L.C

People needed

112

Starts

2019-02-01

Expected to finish

2024-05-29

Last updated by the study team

2024-10-15

Who can join

Age: 30 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Sedentary males and females age 30-65 years with a BMI >30 and/or percent body fat >30%
• Medical clearance for participating in moderate to intense exercise training and testing;
• meet the 2006 International Diabetes Federation criteria for central obesity (ethnicity specific waist circumference) and any two risk factors to metabolic syndrome (i.e., fasting triglycerides > 150 mg/dL or treatment for high triglycerides, HDL <40 mg/dL in males and <50 mg/dL in female, resting SBP >130 mmHg or DBP >85 mmHg or treatment of previously diagnosed hypertension, blood glucose ≥ 100 mg/dl or previous diagnosis for Type II diabetes);
• Absence of limiting musculoskeletal injury that would prevent participation in a general fitness program; and,
• Has given voluntary, written, informed consent to participate in the study.

You may not qualify if…

• Participants will not be allowed to participate in the study if:
• they currently take or have taken nitrous oxide or anti-inflammatory type supplements or medications within one month of the start of the study;
• they have uncontrolled hypertension, triglycerides >500 mg/dL, elevated AST and ALT > 3 times the upper limit, and serum creatinine >1.5 mg/dL);
• They do not receive medical clearance from their personal physician to participate in the study and exercise program;
• They are pregnant or plan to become pregnant; and/or
• They are unable to complete at least 90% of the training.

Where it is running

• Texas A&M University — College Station, Texas, United States

Full record on ClinicalTrials.gov

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