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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Lipid Profile-Cholesterol
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo
2 x 500 mg capsules
干预措施: Placebo (Dietary Supplement)
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
干预措施: Cr-400 (Dietary Supplement)
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)
干预措施: Cr-800 (Dietary Supplement)
Dietary Supplement 3
1 x 500 mg capsule of PE (500mg) + 1 x 500 mg capsule of PLA
干预措施: PE-500 (Dietary Supplement)
Dietary Supplement 4
2 x 500 mg capsules of PE (1000 mg)
干预措施: PE-1000 (Dietary Supplement)
结局指标
主要结局
Lipid Profile-Cholesterol
时间窗: Baseline, 6 weeks and 12 weeks
Changes in the level of cholesterol (mg/dL)
Lipid Profile -Triglycerides
时间窗: Baseline, 6 weeks and 12 weeks
Changes in the level of Triglycerides (mg/dL)
Lipid Profile- HDL Cholesterol
时间窗: Baseline, 6 and 12 weeks
Changes in the level of HDL Cholesterol (mg/dL)
Lipid Profile- LDL Cholesterol
时间窗: Baseline, 6 and 12 weeks
Changes in the level of LDL Cholesterol (mg/dL)
Lipid Profile- Calculated VLDL Cholesterol
时间窗: Baseline, 6 and 12 weeks
Changes in the Calculated VLDL Cholesterol (mg/dL)
Lipid Profile- Risk Ratio (LDL/HDL)
时间窗: Baseline, 6 and 12 weeks
Changes in the Risk Ratio (LDL/HDL)
Lipid Profile- Risk Ratio (Cholesterol/HDL)
时间窗: Baseline, 6 and 12 weeks
Changes in Risk Ratio (Cholesterol/HDL)
C-reactive protein (CRP)
时间窗: Baseline, 6 and 12 weeks
To assess changes in the level of CRP (mg/L)
Flow-Mediated Dilation (FMD)
时间窗: Baseline, 6 and 12 weeks
Percentage of change in the Flow-Mediated Dilation (FMD).
Venous Occlusion (VO)
时间窗: Baseline, 6 and 12 weeks
Changes in the Venous Occlusion (VO) for the FMD cuff: mmHg
Platelet Aggregation
时间窗: Baseline, 6 and 12 weeks
Check participants' Platelet Aggregation (Ohms)
Fasting Glucose
时间窗: Baseline, 6 and 12 weeks
To assess changes in participants' levels of fasting glucose (mg/dL)
HbA1c
时间窗: Baseline, 6 and 12 weeks
To assess changes in the concentration of HbA1c (mmol/mol)
次要结局
- Resting Energy Expenditure(Baseline, 6 and 12 weeks)
- Resting Hemodynamics- blood pressure(Baseline, 6 and 12 weeks)
- Resting Hemodynamics-Weight(Baseline, 6 and 12 weeks)
- Resting hemodynamics- Height(Baseline, 6 and 12 weeks)
- Resting hemodynamics- Fat loss(Baseline, 6 and 12 weeks)
- Maximal Aerobic Capacity(Baseline, 6 and 12 weeks)
- Musculoskeletal Strength(Baseline, 6 and 12 weeks)
- Musculoskeletal Endurance(Baseline, 6 and 12 weeks)
- Inflammatory markers- Creatinine(Baseline, 6 and 12 weeks)
- Inflammatory markers- BUN/Creatine Ratio(Baseline, 6 and 12 weeks)
- Complete Blood Count (CBC)(Baseline, 6 and 12 weeks)
- Metabolic Panel- Sodium(Baseline, 6 and 12 weeks)
- Metabolic Panel- Potassium(Baseline, 6 and 12 weeks)
- Metabolic Panel-Chloride(Baseline, 6 and 12 weeks)
- Metabolic Panel- Carbon Dioxide(Baseline, 6 and 12 weeks)
- Metabolic Panel- Calcium(Baseline, 6 and 12 weeks)
- Metabolic Panel-Protein(Baseline, 6 and 12 weeks)
- Metabolic Panel- Albumin(Baseline, 6 and 12 weeks)
- Metabolic Panel- Globulin(Baseline, 6 and 12 weeks)
- Metabolic Panel- Bilirubin(Baseline, 6 and 12 weeks)
- Metabolic Panel- Alkaline Phosphatase(Baseline, 6 and 12 weeks)
- Profile of Mood States (POMS)(Baseline, 6 and 12 weeks)
- Quality of Life Assessment (QOL)(Baseline, 6 and 12 weeks)
- Cognitive function measures(Baseline, 6 weeks and 12 weeks)
- Inflammatory Markers- High Sensitivity C Reactive Protein(Baseline, 6 and 12 weeks)
- Inflammatory Markers- Aspartate Aminotransferase (AST)(Baseline, 6 and 12 weeks)
- Inflammatory markers- Alanine Transaminase (ALT)(Baseline, 6 and 12 weeks)
- Inflammatory markers- Blood Urea Nitrogen (BUN)(Baseline, 6 and 12 weeks)