Impact of Chromium, Phyllanthus Emblica, and Shilajit on Cardiovascular Health, Fitness, and Weight Loss During Exercise and Diet Programs

Kerry Group P.L.C112 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

112

Conditions

Overweight Metabolic Syndrome X

Interventions

PlaceboDIETARY_SUPPLEMENT

2 capsules of Placebo, once daily after breakfast for 12 weeks

Cr-400DIETARY_SUPPLEMENT

1 capsule of Cr-400 + 1 capsule of Placebo, once a day after breakfast for 12 weeks

Cr-800DIETARY_SUPPLEMENT

2 capsules of Cr-400, once a day after breakfast for 12 weeks

Eligibility

Sex: ALLMin age: 30 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Texas A&M University

College Station, Texas, United States

Outcomes

Primary Outcomes

Flow-Mediated Dilation (FMD)

Percentage of change in the Flow-Mediated Dilation (FMD).

Time frame: Baseline, 6 and 12 weeks

Venous Occlusion (VO)

Changes in the Venous Occlusion (VO) for the FMD cuff: mmHg

Time frame: Baseline, 6 and 12 weeks

Platelet Aggregation

Check participants' Platelet Aggregation (Ohms)

Time frame: Baseline, 6 and 12 weeks

Fasting Glucose

To assess changes in participants' levels of fasting glucose (mg/dL)

Time frame: Baseline, 6 and 12 weeks

HbA1c

To assess changes in the concentration of HbA1c (mmol/mol)

Time frame: Baseline, 6 and 12 weeks

C-reactive protein (CRP)

To assess changes in the level of CRP (mg/L)

Time frame: Baseline, 6 and 12 weeks

Lipid Profile-Cholesterol

Changes in the level of cholesterol (mg/dL)

Time frame: Baseline, 6 weeks and 12 weeks

Lipid Profile -Triglycerides

Changes in the level of Triglycerides (mg/dL)

Time frame: Baseline, 6 weeks and 12 weeks

Lipid Profile- HDL Cholesterol

Changes in the level of HDL Cholesterol (mg/dL)

Time frame: Baseline, 6 and 12 weeks

Data from ClinicalTrials.gov

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Secondary Outcomes

Resting Energy Expenditure

Assessment of the Resting Energy Expenditure (REE) (kcal/day)

Time frame: Baseline, 6 and 12 weeks

Resting Hemodynamics- blood pressure

Blood pressure will be assessed before the exercise test (mmHg)

Time frame: Baseline, 6 and 12 weeks

Resting Hemodynamics-Weight

Weight (kg) will be taken before the exercise test

Time frame: Baseline, 6 and 12 weeks

Resting hemodynamics- Height

Height (m) will be taken before the exercise test

Time frame: Baseline, 6 and 12 weeks

Resting hemodynamics- Fat loss

Assessment of fat loss (kg)

Time frame: Baseline, 6 and 12 weeks

Maximal Aerobic Capacity

Milliliters of oxygen per kilogram of body weight per minute (mL/kg/min)

Time frame: Baseline, 6 and 12 weeks

Musculoskeletal Strength

One Repetition Maximum (1 RM) in pounds (lbs)

Time frame: Baseline, 6 and 12 weeks

Musculoskeletal Endurance

Number of Repetitions (#) at a given percentage of 1RM in pounds (lbs.)

Time frame: 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

Time frame: Baseline, 6 and 12 weeks

Inflammatory Markers- Aspartate Aminotransferase (AST)

Changes in the level of Aspartate Aminotransferase : U/L

Time frame: Baseline, 6 and 12 weeks

Inflammatory markers- Alanine Transaminase (ALT)

Changes in the level of Alanine Transaminase (ALT): U/L

Time frame: Baseline, 6 and 12 weeks

Inflammatory markers- Blood Urea Nitrogen (BUN)

Changes in the level of Blood Urea Nitrogen (BUN)

Time frame: Baseline, 6 and 12 weeks

Inflammatory markers- Creatinine

Changes in the creatinine level (mg/dL)

Time frame: Baseline, 6 and 12 weeks

Inflammatory markers- BUN/Creatine Ratio

Changes in the BUN/Creatine Ratio (Ratio)

Time frame: 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).

Time frame: Baseline, 6 and 12 weeks

Metabolic Panel- Sodium

Changes in Sodium level (MEQ/L)

Time frame: Baseline, 6 and 12 weeks

Metabolic Panel- Potassium

Changes in Potassium level (MEQ/L)

Time frame: Baseline, 6 and 12 weeks

Metabolic Panel-Chloride

Changes in Chloride level (MEQ/L)

Time frame: Baseline, 6 and 12 weeks

Metabolic Panel- Carbon Dioxide

Changes in the level of Carbon Dioxide (MEQ/L)

Time frame: Baseline, 6 and 12 weeks

Metabolic Panel- Calcium

Changes in the level of calcium (mg/dL)

Time frame: Baseline, 6 and 12 weeks

Metabolic Panel-Protein

Changes in the Total level of Protein (g/dL)

Time frame: Baseline, 6 and 12 weeks

Metabolic Panel- Albumin

Changes in the level of Albumin ( g/dL)

Time frame: Baseline, 6 and 12 weeks

Metabolic Panel- Globulin

changes in the level globulin (g/dL)

Time frame: Baseline, 6 and 12 weeks

Metabolic Panel- Bilirubin

Changes in the total level of Bilirubin (mg/dL)

Time frame: Baseline, 6 and 12 weeks

Metabolic Panel- Alkaline Phosphatase

Changes in the level of Alkaline Phosphatase U/L

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline, 6 weeks and 12 weeks