Texas A&M University
College Station, Texas, 77843, United States
NCT Number: NCT06641596
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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Notify Me30 year–65 year
All sexes
Interventional
Not applicable
College Station, Texas, 77843, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will not be allowed to participate in the study if:
2 capsules of Placebo, once daily after breakfast for 12 weeks
1 capsule of Cr-400 + 1 capsule of Placebo, once a day after breakfast for 12 weeks
2 capsules of Cr-400, once a day after breakfast for 12 weeks
1 capsule of PE + 1 capsule of Placebo, once a day after breakfast for 12 weeks
2 capsules of PE-500, once a day after breakfast for 12 weeks
Time frame: Baseline, 6 and 12 weeks
Percentage of change in the Flow-Mediated Dilation (FMD).
Time frame: Baseline, 6 and 12 weeks
Changes in the Venous Occlusion (VO) for the FMD cuff: mmHg
Time frame: Baseline, 6 and 12 weeks
Check participants' Platelet Aggregation (Ohms)
Time frame: Baseline, 6 and 12 weeks
To assess changes in participants' levels of fasting glucose (mg/dL)
Time frame: Baseline, 6 and 12 weeks
To assess changes in the concentration of HbA1c (mmol/mol)
Time frame: Baseline, 6 and 12 weeks
To assess changes in the level of CRP (mg/L)
Time frame: Baseline, 6 weeks and 12 weeks
Changes in the level of cholesterol (mg/dL)
Time frame: Baseline, 6 weeks and 12 weeks
Changes in the level of Triglycerides (mg/dL)
Time frame: Baseline, 6 and 12 weeks
Changes in the level of HDL Cholesterol (mg/dL)
Time frame: Baseline, 6 and 12 weeks
Changes in the level of LDL Cholesterol (mg/dL)
Time frame: Baseline, 6 and 12 weeks
Changes in the Calculated VLDL Cholesterol (mg/dL)
Time frame: Baseline, 6 and 12 weeks
Changes in the Risk Ratio (LDL/HDL)
Time frame: Baseline, 6 and 12 weeks
Changes in Risk Ratio (Cholesterol/HDL)
Time frame: Baseline, 6 and 12 weeks
Assessment of the Resting Energy Expenditure (REE) (kcal/day)
Time frame: Baseline, 6 and 12 weeks
Blood pressure will be assessed before the exercise test (mmHg)
Time frame: Baseline, 6 and 12 weeks
Weight (kg) will be taken before the exercise test
Time frame: Baseline, 6 and 12 weeks
Height (m) will be taken before the exercise test
Time frame: Baseline, 6 and 12 weeks
Assessment of fat loss (kg)
Time frame: Baseline, 6 and 12 weeks
Milliliters of oxygen per kilogram of body weight per minute (mL/kg/min)
Time frame: Baseline, 6 and 12 weeks
One Repetition Maximum (1 RM) in pounds (lbs)
Time frame: Baseline, 6 and 12 weeks
Number of Repetitions (#) at a given percentage of 1RM in pounds (lbs.)
Time frame: Baseline, 6 and 12 weeks
Changes in the level of High Sensitivity C Reactive Protein (hsCRP): mg/L
Time frame: Baseline, 6 and 12 weeks
Changes in the level of Aspartate Aminotransferase : U/L
Time frame: Baseline, 6 and 12 weeks
Changes in the level of Alanine Transaminase (ALT): U/L
Time frame: Baseline, 6 and 12 weeks
Changes in the level of Blood Urea Nitrogen (BUN)
Time frame: Baseline, 6 and 12 weeks
Changes in the creatinine level (mg/dL)
Time frame: Baseline, 6 and 12 weeks
Changes in the BUN/Creatine Ratio (Ratio)
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).
Time frame: Baseline, 6 and 12 weeks
Changes in Sodium level (MEQ/L)
Time frame: Baseline, 6 and 12 weeks
Changes in Potassium level (MEQ/L)
Time frame: Baseline, 6 and 12 weeks
Changes in Chloride level (MEQ/L)
Time frame: Baseline, 6 and 12 weeks
Changes in the level of Carbon Dioxide (MEQ/L)
Time frame: Baseline, 6 and 12 weeks
Changes in the level of calcium (mg/dL)
Time frame: Baseline, 6 and 12 weeks
Changes in the Total level of Protein (g/dL)
Time frame: Baseline, 6 and 12 weeks
Changes in the level of Albumin ( g/dL)
Time frame: Baseline, 6 and 12 weeks
changes in the level globulin (g/dL)
Time frame: Baseline, 6 and 12 weeks
Changes in the total level of Bilirubin (mg/dL)
Time frame: Baseline, 6 and 12 weeks
Changes in the level of Alkaline Phosphatase U/L
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.
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.
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.
Kerry Group P.L.C
Industry
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
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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