Clinical trial NCT06641596: Impact of Chromium, Phyllanthus Emblica, and Shilajit on Cardiovascular Health, Fitness, and Weight Loss During Exercise and Diet Programs
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Metabolic Syndrome X
Lead sponsor: Kerry Group P.L.C
Sponsor class: INDUSTRY
First posted: 2024-10-15
Enrollment: 112
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Flow-Mediated Dilation (FMD)
timeFrame: Baseline, 6 and 12 weeks
measure: Venous Occlusion (VO)
timeFrame: Baseline, 6 and 12 weeks
measure: Platelet Aggregation
timeFrame: Baseline, 6 and 12 weeks
measure: Fasting Glucose
timeFrame: Baseline, 6 and 12 weeks
measure: HbA1c
timeFrame: Baseline, 6 and 12 weeks
measure: C-reactive protein (CRP)
timeFrame: Baseline, 6 and 12 weeks
measure: Lipid Profile-Cholesterol
timeFrame: Baseline, 6 weeks and 12 weeks
measure: Lipid Profile -Triglycerides
timeFrame: Baseline, 6 weeks and 12 weeks
measure: Lipid Profile- HDL Cholesterol
timeFrame: Baseline, 6 and 12 weeks
measure: Lipid Profile- LDL Cholesterol
timeFrame: Baseline, 6 and 12 weeks
measure: Lipid Profile- Calculated VLDL Cholesterol
timeFrame: Baseline, 6 and 12 weeks
measure: Lipid Profile- Risk Ratio (LDL/HDL)
timeFrame: Baseline, 6 and 12 weeks
measure: Lipid Profile- Risk Ratio (Cholesterol/HDL)
timeFrame: Baseline, 6 and 12 weeks
Secondary outcomes:
measure: Resting Energy Expenditure
timeFrame: Baseline, 6 and 12 weeks
measure: Resting Hemodynamics- blood pressure
timeFrame: Baseline, 6 and 12 weeks
measure: Resting Hemodynamics-Weight
timeFrame: Baseline, 6 and 12 weeks
measure: Resting hemodynamics- Height
timeFrame: Baseline, 6 and 12 weeks
measure: Resting hemodynamics- Fat loss
timeFrame: Baseline, 6 and 12 weeks
measure: Maximal Aerobic Capacity
timeFrame: Baseline, 6 and 12 weeks
measure: Musculoskeletal Strength
timeFrame: Baseline, 6 and 12 weeks
measure: Musculoskeletal Endurance
timeFrame: Baseline, 6 and 12 weeks
measure: Inflammatory Markers- High Sensitivity C Reactive Protein
timeFrame: Baseline, 6 and 12 weeks
measure: Inflammatory Markers- Aspartate Aminotransferase (AST)
timeFrame: Baseline, 6 and 12 weeks
measure: Inflammatory markers- Alanine Transaminase (ALT)
timeFrame: Baseline, 6 and 12 weeks
measure: Inflammatory markers- Blood Urea Nitrogen (BUN)
timeFrame: Baseline, 6 and 12 weeks
measure: Inflammatory markers- Creatinine
timeFrame: Baseline, 6 and 12 weeks
measure: Inflammatory markers- BUN/Creatine Ratio
timeFrame: Baseline, 6 and 12 weeks
measure: Complete Blood Count (CBC)
timeFrame: Baseline, 6 and 12 weeks
measure: Metabolic Panel- Sodium
timeFrame: Baseline, 6 and 12 weeks
measure: Metabolic Panel- Potassium
timeFrame: Baseline, 6 and 12 weeks
measure: Metabolic Panel-Chloride
timeFrame: Baseline, 6 and 12 weeks
measure: Metabolic Panel- Carbon Dioxide
timeFrame: Baseline, 6 and 12 weeks
measure: Metabolic Panel- Calcium
timeFrame: Baseline, 6 and 12 weeks
measure: Metabolic Panel-Protein
timeFrame: Baseline, 6 and 12 weeks
measure: Metabolic Panel- Albumin
timeFrame: Baseline, 6 and 12 weeks
measure: Metabolic Panel- Globulin
timeFrame: Baseline, 6 and 12 weeks
measure: Metabolic Panel- Bilirubin
timeFrame: Baseline, 6 and 12 weeks
measure: Metabolic Panel- Alkaline Phosphatase
timeFrame: Baseline, 6 and 12 weeks
measure: Profile of Mood States (POMS)
timeFrame: Baseline, 6 and 12 weeks
measure: Quality of Life Assessment (QOL)
timeFrame: Baseline, 6 and 12 weeks
measure: Cognitive function measures
timeFrame: Baseline, 6 weeks and 12 weeks
Other outcomes:
Locations:
city: College Station
country: United States
facility: Texas A&M University
state: Texas
Study officials:
References: