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

Kerry Group

Status: Completed

Conditions: Overweight; Metabolic Syndrome X

Treatments: Dietary Supplement: Cr-800; Dietary Supplement: PE-1000; Dietary Supplement: Cr-400; Dietary Supplement: PE-500; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06641596

S23-1467336

Details and patient eligibility

About

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.

Full 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.

Enrollment: 112 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Sedentary males and females age 30-65 years with a BMI >30 and/or percent body fat >30%
2. Medical clearance for participating in moderate to intense exercise training and testing;
3. 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);
4. Absence of limiting musculoskeletal injury that would prevent participation in a general fitness program; and,
5. Has given voluntary, written, informed consent to participate in the study.

Exclusion criteria

Participants will not be allowed to participate in the study if:

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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112 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

2 x 500 mg capsules

Treatment:

Dietary Supplement: Placebo

Dietary Supplement 1

Experimental group

Description:

1 x 20 mg capsule of Cr-400 (formulation of 400 mcg of trivalent chromium with 6 mg of PE and 6 mg of SJ) + 1x500 capsule of PLA

Treatment:

Dietary Supplement: Cr-400

Dietary Supplement 2

Experimental group

Description:

2 x 20 mg capsule of Cr-400 (formulation of 400 mcg of trivalent chromium with 6 mg of PE and 6 mg of SJ)

Treatment:

Dietary Supplement: Cr-800

Dietary Supplement 3

Experimental group

Description:

1 x 500 mg capsule of PE (500mg) + 1 x 500 mg capsule of PLA

Treatment:

Dietary Supplement: PE-500

Dietary Supplement 4

Experimental group

Description:

2 x 500 mg capsules of PE (1000 mg)

Treatment:

Dietary Supplement: PE-1000