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

NCT06641596 | Completed

• 1 other identifier: S23-1467336
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Metabolic Syndrome X

Outcome Measures

Primary Outcomes (13)

• Flow-Mediated Dilation (FMD)

  Percentage of change in the Flow-Mediated Dilation (FMD).

  Baseline, 6 and 12 weeks

• Venous Occlusion (VO)

  Changes in the Venous Occlusion (VO) for the FMD cuff: mmHg

  Baseline, 6 and 12 weeks

• Platelet Aggregation

  Check participants' Platelet Aggregation (Ohms)

  Baseline, 6 and 12 weeks

• Fasting Glucose

  To assess changes in participants' levels of fasting glucose (mg/dL)

  Baseline, 6 and 12 weeks

• HbA1c

  To assess changes in the concentration of HbA1c (mmol/mol)

  Baseline, 6 and 12 weeks

• C-reactive protein (CRP)

  To assess changes in the level of CRP (mg/L)

  Baseline, 6 and 12 weeks

• Lipid Profile-Cholesterol

  Changes in the level of cholesterol (mg/dL)

  Baseline, 6 weeks and 12 weeks

• Lipid Profile -Triglycerides

  Changes in the level of Triglycerides (mg/dL)

  Baseline, 6 weeks and 12 weeks

• Lipid Profile- HDL Cholesterol

  Changes in the level of HDL Cholesterol (mg/dL)

  Baseline, 6 and 12 weeks

• Lipid Profile- LDL Cholesterol

  Changes in the level of LDL Cholesterol (mg/dL)

  Baseline, 6 and 12 weeks

• Lipid Profile- Calculated VLDL Cholesterol

  Changes in the Calculated VLDL Cholesterol (mg/dL)

  Baseline, 6 and 12 weeks

• Lipid Profile- Risk Ratio (LDL/HDL)

  Changes in the Risk Ratio (LDL/HDL)

  Baseline, 6 and 12 weeks

• Lipid Profile- Risk Ratio (Cholesterol/HDL)

  Changes in Risk Ratio (Cholesterol/HDL)

  Baseline, 6 and 12 weeks

Secondary Outcomes (28)

• Resting Energy Expenditure

  Baseline, 6 and 12 weeks

• Resting Hemodynamics- blood pressure

  Baseline, 6 and 12 weeks

• Resting Hemodynamics-Weight

  Baseline, 6 and 12 weeks

• Resting hemodynamics- Height

  Baseline, 6 and 12 weeks

• Resting hemodynamics- Fat loss

  Baseline, 6 and 12 weeks

Study Arms (5)

Placebo

PLACEBO COMPARATOR

2 x 500 mg capsules

Dietary Supplement: Placebo

Dietary Supplement 1

EXPERIMENTAL

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

Dietary Supplement: Cr-400

Dietary Supplement 2

EXPERIMENTAL

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)

Dietary Supplement: Cr-800

Dietary Supplement 3

EXPERIMENTAL

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

Dietary Supplement: PE-500

Dietary Supplement 4

EXPERIMENTAL

2 x 500 mg capsules of PE (1000 mg)

Dietary Supplement: PE-1000

Interventions

Placebo DIETARY_SUPPLEMENT

2 capsules of Placebo, once daily after breakfast for 12 weeks

Placebo

Cr-400 DIETARY_SUPPLEMENT

1 capsule of Cr-400 + 1 capsule of Placebo, once a day after breakfast for 12 weeks

Dietary Supplement 1

Cr-800 DIETARY_SUPPLEMENT

2 capsules of Cr-400, once a day after breakfast for 12 weeks

Dietary Supplement 2

PE-500 DIETARY_SUPPLEMENT

1 capsule of PE + 1 capsule of Placebo, once a day after breakfast for 12 weeks

Dietary Supplement 3

PE-1000 DIETARY_SUPPLEMENT

2 capsules of PE-500, once a day after breakfast for 12 weeks

Dietary Supplement 4

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Kerry Group P.L.C: lead

Study Sites (1)

Texas A&M University

College Station, Texas, 77843, United States

Location

Related Publications (1)

• Martinez V, McAngus K, Dickerson BL, Leonard M, Chavez E, Chun J, Lewis M, Xing D, Gonzalez DE, Yoo C, Ko J, Rhodes H, Lee H, Sowinski RJ, Rasmussen CJ, Kreider RB. Effects of 12 Weeks of Chromium, Phyllanthus emblica Fruit Extract, and Shilajit Supplementation on Markers of Cardiometabolic Health, Fitness, and Weight Loss in Men and Women with Risk Factors to Metabolic Syndrome Initiating an Exercise and Diet Intervention: A Randomized Double-Blind, Placebo-Controlled Trial. Nutrients. 2025 Jun 19;17(12):2042. doi: 10.3390/nu17122042.

  PMID: 40573153 DERIVED

MeSH Terms

Conditions

Overweight; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 24 participants per group equally comprised of men and women matched as closely as possible by age, gender, BMI, and body mass

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: October 15, 2024
• Study Start: February 1, 2019
• Primary Completion: January 30, 2024
• Study Completion: May 29, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)