Impact of Chromium, Phyllanthus Emblica, and Shilajit on Cardiovascular Health, Fitness, and Weight Loss During Exercise and Diet Programs
NCT ID: NCT06641596
Last Updated: 2024-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
112 participants
INTERVENTIONAL
2019-02-01
2024-05-29
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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Placebo
2 x 500 mg capsules
Placebo
2 capsules of Placebo, once daily after breakfast for 12 weeks
Dietary Supplement 1
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
Cr-400
1 capsule of Cr-400 + 1 capsule of Placebo, once a day after breakfast for 12 weeks
Dietary Supplement 2
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)
Cr-800
2 capsules of Cr-400, once a day after breakfast for 12 weeks
Dietary Supplement 3
1 x 500 mg capsule of PE (500mg) + 1 x 500 mg capsule of PLA
PE-500
1 capsule of PE + 1 capsule of Placebo, once a day after breakfast for 12 weeks
Dietary Supplement 4
2 x 500 mg capsules of PE (1000 mg)
PE-1000
2 capsules of PE-500, once a day after breakfast for 12 weeks
Interventions
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Placebo
2 capsules of Placebo, once daily after breakfast for 12 weeks
Cr-400
1 capsule of Cr-400 + 1 capsule of Placebo, once a day after breakfast for 12 weeks
Cr-800
2 capsules of Cr-400, once a day after breakfast for 12 weeks
PE-500
1 capsule of PE + 1 capsule of Placebo, once a day after breakfast for 12 weeks
PE-1000
2 capsules of PE-500, once a day after breakfast for 12 weeks
Eligibility Criteria
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Inclusion Criteria
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
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.
30 Years
65 Years
ALL
Yes
Sponsors
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Kerry Group P.L.C
INDUSTRY
Responsible Party
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Locations
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Texas A&M University
College Station, Texas, United States
Countries
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References
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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.
Other Identifiers
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S23-1467336
Identifier Type: -
Identifier Source: org_study_id
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