Metabolic Syndrome X, Overweight
Conditions
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTPlacebo
2 capsules of Placebo, once daily after breakfast for 12 weeks
DIETARY_SUPPLEMENTCr-400
1 capsule of Cr-400 + 1 capsule of Placebo, once a day after breakfast for 12 weeks
DIETARY_SUPPLEMENTCr-800
2 capsules of Cr-400, once a day after breakfast for 12 weeks
DIETARY_SUPPLEMENTPE-500
1 capsule of PE + 1 capsule of Placebo, once a day after breakfast for 12 weeks
DIETARY_SUPPLEMENTPE-1000
2 capsules of PE-500, once a day after breakfast for 12 weeks
Sponsors
Kerry Group P.L.C
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
24 participants per group equally comprised of men and women matched as closely as possible by age, gender, BMI, and body mass
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Sedentary males and females age 30-65 years with a BMI \>30 and/or percent body fat \>30% 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
Participants will not be allowed to participate in the study if: 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lipid Profile- Risk Ratio (LDL/HDL) | Baseline, 6 and 12 weeks | Changes in the Risk Ratio (LDL/HDL) |
| Lipid Profile- Risk Ratio (Cholesterol/HDL) | Baseline, 6 and 12 weeks | Changes in Risk Ratio (Cholesterol/HDL) |
| Flow-Mediated Dilation (FMD) | Baseline, 6 and 12 weeks | Percentage of change in the Flow-Mediated Dilation (FMD). |
| Venous Occlusion (VO) | Baseline, 6 and 12 weeks | Changes in the Venous Occlusion (VO) for the FMD cuff: mmHg |
| Platelet Aggregation | Baseline, 6 and 12 weeks | Check participants' Platelet Aggregation (Ohms) |
| Fasting Glucose | Baseline, 6 and 12 weeks | To assess changes in participants' levels of fasting glucose (mg/dL) |
| HbA1c | Baseline, 6 and 12 weeks | To assess changes in the concentration of HbA1c (mmol/mol) |
| C-reactive protein (CRP) | Baseline, 6 and 12 weeks | To assess changes in the level of CRP (mg/L) |
| Lipid Profile-Cholesterol | Baseline, 6 weeks and 12 weeks | Changes in the level of cholesterol (mg/dL) |
| Lipid Profile -Triglycerides | Baseline, 6 weeks and 12 weeks | Changes in the level of Triglycerides (mg/dL) |
| Lipid Profile- HDL Cholesterol | Baseline, 6 and 12 weeks | Changes in the level of HDL Cholesterol (mg/dL) |
| Lipid Profile- LDL Cholesterol | Baseline, 6 and 12 weeks | Changes in the level of LDL Cholesterol (mg/dL) |
| Lipid Profile- Calculated VLDL Cholesterol | Baseline, 6 and 12 weeks | Changes in the Calculated VLDL Cholesterol (mg/dL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory markers- BUN/Creatine Ratio | Baseline, 6 and 12 weeks | Changes in the BUN/Creatine Ratio (Ratio) |
| Complete Blood Count (CBC) | 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). |
| Metabolic Panel- Sodium | Baseline, 6 and 12 weeks | Changes in Sodium level (MEQ/L) |
| Metabolic Panel- Potassium | Baseline, 6 and 12 weeks | Changes in Potassium level (MEQ/L) |
| Metabolic Panel-Chloride | Baseline, 6 and 12 weeks | Changes in Chloride level (MEQ/L) |
| Metabolic Panel- Carbon Dioxide | Baseline, 6 and 12 weeks | Changes in the level of Carbon Dioxide (MEQ/L) |
| Metabolic Panel- Calcium | Baseline, 6 and 12 weeks | Changes in the level of calcium (mg/dL) |
| Metabolic Panel-Protein | Baseline, 6 and 12 weeks | Changes in the Total level of Protein (g/dL) |
| Metabolic Panel- Albumin | Baseline, 6 and 12 weeks | Changes in the level of Albumin ( g/dL) |
| Metabolic Panel- Globulin | Baseline, 6 and 12 weeks | changes in the level globulin (g/dL) |
| Metabolic Panel- Bilirubin | Baseline, 6 and 12 weeks | Changes in the total level of Bilirubin (mg/dL) |
| Metabolic Panel- Alkaline Phosphatase | Baseline, 6 and 12 weeks | Changes in the level of Alkaline Phosphatase U/L |
| Resting Energy Expenditure | Baseline, 6 and 12 weeks | Assessment of the Resting Energy Expenditure (REE) (kcal/day) |
| Quality of Life Assessment (QOL) | 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. |
| Cognitive function measures | 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. |
| Profile of Mood States (POMS) | Baseline, 6 and 12 weeks | Scoring Range of -28 to 232. A higher score on the POMS indicated a greater degree of mood disturbance. |
| Resting Hemodynamics- blood pressure | Baseline, 6 and 12 weeks | Blood pressure will be assessed before the exercise test (mmHg) |
| Resting Hemodynamics-Weight | Baseline, 6 and 12 weeks | Weight (kg) will be taken before the exercise test |
| Resting hemodynamics- Height | Baseline, 6 and 12 weeks | Height (m) will be taken before the exercise test |
| Resting hemodynamics- Fat loss | Baseline, 6 and 12 weeks | Assessment of fat loss (kg) |
| Maximal Aerobic Capacity | Baseline, 6 and 12 weeks | Milliliters of oxygen per kilogram of body weight per minute (mL/kg/min) |
| Musculoskeletal Strength | Baseline, 6 and 12 weeks | One Repetition Maximum (1 RM) in pounds (lbs) |
| Musculoskeletal Endurance | Baseline, 6 and 12 weeks | Number of Repetitions (#) at a given percentage of 1RM in pounds (lbs.) |
| Inflammatory Markers- High Sensitivity C Reactive Protein | Baseline, 6 and 12 weeks | Changes in the level of High Sensitivity C Reactive Protein (hsCRP): mg/L |
| Inflammatory Markers- Aspartate Aminotransferase (AST) | Baseline, 6 and 12 weeks | Changes in the level of Aspartate Aminotransferase : U/L |
| Inflammatory markers- Alanine Transaminase (ALT) | Baseline, 6 and 12 weeks | Changes in the level of Alanine Transaminase (ALT): U/L |
| Inflammatory markers- Blood Urea Nitrogen (BUN) | Baseline, 6 and 12 weeks | Changes in the level of Blood Urea Nitrogen (BUN) |
| Inflammatory markers- Creatinine | Baseline, 6 and 12 weeks | Changes in the creatinine level (mg/dL) |
Countries
United States
Outcome results
None listed