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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 2 x 500 mg capsules |
|
| 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 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 3 | Experimental | 1 x 500 mg capsule of PE (500mg) + 1 x 500 mg capsule of PLA |
|
| Dietary Supplement 4 | Experimental | 2 x 500 mg capsules of PE (1000 mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | 2 capsules of Placebo, once daily after breakfast for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Resting Energy Expenditure | Assessment of the Resting Energy Expenditure (REE) (kcal/day) | Baseline, 6 and 12 weeks |
| Resting Hemodynamics- blood pressure | Blood pressure will be assessed before the exercise test (mmHg) |
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Inclusion Criteria:
Exclusion Criteria:
Participants will not be allowed to participate in the study if:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas A&M University | College Station | Texas | 77843 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40573153 | Derived | 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. |
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24 participants per group equally comprised of men and women matched as closely as possible by age, gender, BMI, and body mass
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| 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 |
|
| 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 |
| Baseline, 6 and 12 weeks |
| Resting Hemodynamics-Weight | Weight (kg) will be taken before the exercise test | Baseline, 6 and 12 weeks |
| Resting hemodynamics- Height | Height (m) will be taken before the exercise test | Baseline, 6 and 12 weeks |
| Resting hemodynamics- Fat loss | Assessment of fat loss (kg) | Baseline, 6 and 12 weeks |
| Maximal Aerobic Capacity | Milliliters of oxygen per kilogram of body weight per minute (mL/kg/min) | Baseline, 6 and 12 weeks |
| Musculoskeletal Strength | One Repetition Maximum (1 RM) in pounds (lbs) | Baseline, 6 and 12 weeks |
| Musculoskeletal Endurance | Number of Repetitions (#) at a given percentage of 1RM in pounds (lbs.) | Baseline, 6 and 12 weeks |
| Inflammatory Markers- High Sensitivity C Reactive Protein | Changes in the level of High Sensitivity C Reactive Protein (hsCRP): mg/L | Baseline, 6 and 12 weeks |
| Inflammatory Markers- Aspartate Aminotransferase (AST) | Changes in the level of Aspartate Aminotransferase : U/L | Baseline, 6 and 12 weeks |
| Inflammatory markers- Alanine Transaminase (ALT) | Changes in the level of Alanine Transaminase (ALT): U/L | Baseline, 6 and 12 weeks |
| Inflammatory markers- Blood Urea Nitrogen (BUN) | Changes in the level of Blood Urea Nitrogen (BUN) | Baseline, 6 and 12 weeks |
| Inflammatory markers- Creatinine | Changes in the creatinine level (mg/dL) | Baseline, 6 and 12 weeks |
| Inflammatory markers- BUN/Creatine Ratio | Changes in the BUN/Creatine Ratio (Ratio) | Baseline, 6 and 12 weeks |
| Complete Blood Count (CBC) | CBC with differential will be measured using automated hematology analyzer. CBC parameters will be measured in their respective units (e.g., cells per microliter). | Baseline, 6 and 12 weeks |
| Metabolic Panel- Sodium | Changes in Sodium level (MEQ/L) | Baseline, 6 and 12 weeks |
| Metabolic Panel- Potassium | Changes in Potassium level (MEQ/L) | Baseline, 6 and 12 weeks |
| Metabolic Panel-Chloride | Changes in Chloride level (MEQ/L) | Baseline, 6 and 12 weeks |
| Metabolic Panel- Carbon Dioxide | Changes in the level of Carbon Dioxide (MEQ/L) | Baseline, 6 and 12 weeks |
| Metabolic Panel- Calcium | Changes in the level of calcium (mg/dL) | Baseline, 6 and 12 weeks |
| Metabolic Panel-Protein | Changes in the Total level of Protein (g/dL) | Baseline, 6 and 12 weeks |
| Metabolic Panel- Albumin | Changes in the level of Albumin ( g/dL) | Baseline, 6 and 12 weeks |
| Metabolic Panel- Globulin | changes in the level globulin (g/dL) | Baseline, 6 and 12 weeks |
| Metabolic Panel- Bilirubin | Changes in the total level of Bilirubin (mg/dL) | Baseline, 6 and 12 weeks |
| Metabolic Panel- Alkaline Phosphatase | Changes in the level of Alkaline Phosphatase U/L | Baseline, 6 and 12 weeks |
| Profile of Mood States (POMS) | Scoring Range of -28 to 232. A higher score on the POMS indicated a greater degree of mood disturbance. | Baseline, 6 and 12 weeks |
| Quality of Life Assessment (QOL) | To be evaluated using the The 36-Item Short Form Health Survey (SF-36). A higher score indicates a higher quality of life. | Baseline, 6 and 12 weeks |
| Cognitive function measures | 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. | Baseline, 6 weeks and 12 weeks |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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