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

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

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.

Study Overview

• Status: Completed
• Conditions: Overweight; Metabolic Syndrome X
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Cr-400; Dietary supplement: Cr-800; Dietary supplement: PE-500; Dietary supplement: PE-1000

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.

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • College Station, Texas, United States, 77843
      • Texas A&M University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 2 x 500 mg capsules	Dietary supplement: Placebo; 2 capsules of Placebo, once daily after breakfast for 12 weeks
Experimental: 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	Dietary supplement: Cr-400; 1 capsule of Cr-400 + 1 capsule of Placebo, once a day after breakfast for 12 weeks
Experimental: 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)	Dietary supplement: Cr-800; 2 capsules of Cr-400, once a day after breakfast for 12 weeks
Experimental: Dietary Supplement 3; 1 x 500 mg capsule of PE (500mg) + 1 x 500 mg capsule of PLA	Dietary supplement: PE-500; 1 capsule of PE + 1 capsule of Placebo, once a day after breakfast for 12 weeks
Experimental: Dietary Supplement 4; 2 x 500 mg capsules of PE (1000 mg)	Dietary supplement: PE-1000; 2 capsules of PE-500, once a day after breakfast for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flow-Mediated Dilation (FMD)	Percentage of change in the Flow-Mediated Dilation (FMD).	Baseline, 6 and 12 weeks
Venous Occlusion (VO)	Changes in the Venous Occlusion (VO) for the FMD cuff: mmHg	Baseline, 6 and 12 weeks
Platelet Aggregation	Check participants' Platelet Aggregation (Ohms)	Baseline, 6 and 12 weeks
Fasting Glucose	To assess changes in participants' levels of fasting glucose (mg/dL)	Baseline, 6 and 12 weeks
HbA1c	To assess changes in the concentration of HbA1c (mmol/mol)	Baseline, 6 and 12 weeks
C-reactive protein (CRP)	To assess changes in the level of CRP (mg/L)	Baseline, 6 and 12 weeks
Lipid Profile-Cholesterol	Changes in the level of cholesterol (mg/dL)	Baseline, 6 weeks and 12 weeks
Lipid Profile -Triglycerides	Changes in the level of Triglycerides (mg/dL)	Baseline, 6 weeks and 12 weeks
Lipid Profile- HDL Cholesterol	Changes in the level of HDL Cholesterol (mg/dL)	Baseline, 6 and 12 weeks
Lipid Profile- LDL Cholesterol	Changes in the level of LDL Cholesterol (mg/dL)	Baseline, 6 and 12 weeks
Lipid Profile- Calculated VLDL Cholesterol	Changes in the Calculated VLDL Cholesterol (mg/dL)	Baseline, 6 and 12 weeks
Lipid Profile- Risk Ratio (LDL/HDL)	Changes in the Risk Ratio (LDL/HDL)	Baseline, 6 and 12 weeks
Lipid Profile- Risk Ratio (Cholesterol/HDL)	Changes in Risk Ratio (Cholesterol/HDL)	Baseline, 6 and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resting Energy Expenditure	Assessment of the Resting Energy Expenditure (REE) (kcal/day)	Baseline, 6 and 12 weeks
Resting Hemodynamics- blood pressure	Blood pressure will be assessed before the exercise test (mmHg)	Baseline, 6 and 12 weeks
Resting Hemodynamics-Weight	Weight (kg) will be taken before the exercise test	Baseline, 6 and 12 weeks
Resting hemodynamics- Height	Height (m) will be taken before the exercise test	Baseline, 6 and 12 weeks
Resting hemodynamics- Fat loss	Assessment of fat loss (kg)	Baseline, 6 and 12 weeks
Maximal Aerobic Capacity	Milliliters of oxygen per kilogram of body weight per minute (mL/kg/min)	Baseline, 6 and 12 weeks
Musculoskeletal Strength	One Repetition Maximum (1 RM) in pounds (lbs)	Baseline, 6 and 12 weeks
Musculoskeletal Endurance	Number of Repetitions (#) at a given percentage of 1RM in pounds (lbs.)	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	Baseline, 6 and 12 weeks
Inflammatory Markers- Aspartate Aminotransferase (AST)	Changes in the level of Aspartate Aminotransferase : U/L	Baseline, 6 and 12 weeks
Inflammatory markers- Alanine Transaminase (ALT)	Changes in the level of Alanine Transaminase (ALT): U/L	Baseline, 6 and 12 weeks
Inflammatory markers- Blood Urea Nitrogen (BUN)	Changes in the level of Blood Urea Nitrogen (BUN)	Baseline, 6 and 12 weeks
Inflammatory markers- Creatinine	Changes in the creatinine level (mg/dL)	Baseline, 6 and 12 weeks
Inflammatory markers- BUN/Creatine Ratio	Changes in the BUN/Creatine Ratio (Ratio)	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).	Baseline, 6 and 12 weeks
Metabolic Panel- Sodium	Changes in Sodium level (MEQ/L)	Baseline, 6 and 12 weeks
Metabolic Panel- Potassium	Changes in Potassium level (MEQ/L)	Baseline, 6 and 12 weeks
Metabolic Panel-Chloride	Changes in Chloride level (MEQ/L)	Baseline, 6 and 12 weeks
Metabolic Panel- Carbon Dioxide	Changes in the level of Carbon Dioxide (MEQ/L)	Baseline, 6 and 12 weeks
Metabolic Panel- Calcium	Changes in the level of calcium (mg/dL)	Baseline, 6 and 12 weeks
Metabolic Panel-Protein	Changes in the Total level of Protein (g/dL)	Baseline, 6 and 12 weeks
Metabolic Panel- Albumin	Changes in the level of Albumin ( g/dL)	Baseline, 6 and 12 weeks
Metabolic Panel- Globulin	changes in the level globulin (g/dL)	Baseline, 6 and 12 weeks
Metabolic Panel- Bilirubin	Changes in the total level of Bilirubin (mg/dL)	Baseline, 6 and 12 weeks
Metabolic Panel- Alkaline Phosphatase	Changes in the level of Alkaline Phosphatase U/L	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.	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.	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.	Baseline, 6 weeks and 12 weeks

Collaborators and Investigators

• Sponsor: Kerry Group P.L.C

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): January 30, 2024
• Study Completion (Actual): May 29, 2024

Study Registration Dates

• First Submitted: September 11, 2024
• First Submitted That Met QC Criteria: October 10, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 10, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Insulin Resistance; Hyperinsulinism; Body Weight Changes; Metabolic Syndrome; Weight Loss; Overweight
• Other Study ID Numbers: S23-1467336

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No