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Completed

NCT Number: NCT06641596

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

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.

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Key information

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Texas A&M University

College Station, Texas, 77843, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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.

Treatment and study plan

Placebo

Dietary Supplement

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

Cr-400

Dietary Supplement

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

Cr-800

Dietary Supplement

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

PE-500

Dietary Supplement

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

PE-1000

Dietary Supplement

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

Primary outcomes

  1. Flow-Mediated Dilation (FMD)

    Time frame: Baseline, 6 and 12 weeks

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

  2. Venous Occlusion (VO)

    Time frame: Baseline, 6 and 12 weeks

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

  3. Platelet Aggregation

    Time frame: Baseline, 6 and 12 weeks

    Check participants' Platelet Aggregation (Ohms)

  4. Fasting Glucose

    Time frame: Baseline, 6 and 12 weeks

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

  5. HbA1c

    Time frame: Baseline, 6 and 12 weeks

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

  6. C-reactive protein (CRP)

    Time frame: Baseline, 6 and 12 weeks

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

  7. Lipid Profile-Cholesterol

    Time frame: Baseline, 6 weeks and 12 weeks

    Changes in the level of cholesterol (mg/dL)

  8. Lipid Profile -Triglycerides

    Time frame: Baseline, 6 weeks and 12 weeks

    Changes in the level of Triglycerides (mg/dL)

  9. Lipid Profile- HDL Cholesterol

    Time frame: Baseline, 6 and 12 weeks

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

  10. Lipid Profile- LDL Cholesterol

    Time frame: Baseline, 6 and 12 weeks

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

  11. Lipid Profile- Calculated VLDL Cholesterol

    Time frame: Baseline, 6 and 12 weeks

    Changes in the Calculated VLDL Cholesterol (mg/dL)

  12. Lipid Profile- Risk Ratio (LDL/HDL)

    Time frame: Baseline, 6 and 12 weeks

    Changes in the Risk Ratio (LDL/HDL)

  13. Lipid Profile- Risk Ratio (Cholesterol/HDL)

    Time frame: Baseline, 6 and 12 weeks

    Changes in Risk Ratio (Cholesterol/HDL)

Secondary outcomes

  1. Resting Energy Expenditure

    Time frame: Baseline, 6 and 12 weeks

    Assessment of the Resting Energy Expenditure (REE) (kcal/day)

  2. Resting Hemodynamics- blood pressure

    Time frame: Baseline, 6 and 12 weeks

    Blood pressure will be assessed before the exercise test (mmHg)

  3. Resting Hemodynamics-Weight

    Time frame: Baseline, 6 and 12 weeks

    Weight (kg) will be taken before the exercise test

  4. Resting hemodynamics- Height

    Time frame: Baseline, 6 and 12 weeks

    Height (m) will be taken before the exercise test

  5. Resting hemodynamics- Fat loss

    Time frame: Baseline, 6 and 12 weeks

    Assessment of fat loss (kg)

  6. Maximal Aerobic Capacity

    Time frame: Baseline, 6 and 12 weeks

    Milliliters of oxygen per kilogram of body weight per minute (mL/kg/min)

  7. Musculoskeletal Strength

    Time frame: Baseline, 6 and 12 weeks

    One Repetition Maximum (1 RM) in pounds (lbs)

  8. Musculoskeletal Endurance

    Time frame: Baseline, 6 and 12 weeks

    Number of Repetitions (#) at a given percentage of 1RM in pounds (lbs.)

  9. Inflammatory Markers- High Sensitivity C Reactive Protein

    Time frame: Baseline, 6 and 12 weeks

    Changes in the level of High Sensitivity C Reactive Protein (hsCRP): mg/L

  10. Inflammatory Markers- Aspartate Aminotransferase (AST)

    Time frame: Baseline, 6 and 12 weeks

    Changes in the level of Aspartate Aminotransferase : U/L

  11. Inflammatory markers- Alanine Transaminase (ALT)

    Time frame: Baseline, 6 and 12 weeks

    Changes in the level of Alanine Transaminase (ALT): U/L

  12. Inflammatory markers- Blood Urea Nitrogen (BUN)

    Time frame: Baseline, 6 and 12 weeks

    Changes in the level of Blood Urea Nitrogen (BUN)

  13. Inflammatory markers- Creatinine

    Time frame: Baseline, 6 and 12 weeks

    Changes in the creatinine level (mg/dL)

  14. Inflammatory markers- BUN/Creatine Ratio

    Time frame: Baseline, 6 and 12 weeks

    Changes in the BUN/Creatine Ratio (Ratio)

  15. Complete Blood Count (CBC)

    Time frame: Baseline, 6 and 12 weeks

    CBC with differential will be measured using automated hematology analyzer. CBC parameters will be measured in their respective units (e.g., cells per microliter).

  16. Metabolic Panel- Sodium

    Time frame: Baseline, 6 and 12 weeks

    Changes in Sodium level (MEQ/L)

  17. Metabolic Panel- Potassium

    Time frame: Baseline, 6 and 12 weeks

    Changes in Potassium level (MEQ/L)

  18. Metabolic Panel-Chloride

    Time frame: Baseline, 6 and 12 weeks

    Changes in Chloride level (MEQ/L)

  19. Metabolic Panel- Carbon Dioxide

    Time frame: Baseline, 6 and 12 weeks

    Changes in the level of Carbon Dioxide (MEQ/L)

  20. Metabolic Panel- Calcium

    Time frame: Baseline, 6 and 12 weeks

    Changes in the level of calcium (mg/dL)

  21. Metabolic Panel-Protein

    Time frame: Baseline, 6 and 12 weeks

    Changes in the Total level of Protein (g/dL)

  22. Metabolic Panel- Albumin

    Time frame: Baseline, 6 and 12 weeks

    Changes in the level of Albumin ( g/dL)

  23. Metabolic Panel- Globulin

    Time frame: Baseline, 6 and 12 weeks

    changes in the level globulin (g/dL)

  24. Metabolic Panel- Bilirubin

    Time frame: Baseline, 6 and 12 weeks

    Changes in the total level of Bilirubin (mg/dL)

  25. Metabolic Panel- Alkaline Phosphatase

    Time frame: Baseline, 6 and 12 weeks

    Changes in the level of Alkaline Phosphatase U/L

  26. Profile of Mood States (POMS)

    Time frame: Baseline, 6 and 12 weeks

    Scoring Range of -28 to 232. A higher score on the POMS indicated a greater degree of mood disturbance.

  27. Quality of Life Assessment (QOL)

    Time frame: Baseline, 6 and 12 weeks

    To be evaluated using the The 36-Item Short Form Health Survey (SF-36). A higher score indicates a higher quality of life.

  28. Cognitive function measures

    Time frame: Baseline, 6 weeks and 12 weeks

    The Changes in the cognitive function measures to be evaluated using the troop Color-Word test. A higher score on the Stroop indicated better performance and less interference on reading ability.

Sponsors and collaborators

Lead sponsor

Kerry Group P.L.C

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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