OverweightNCT06641596
Impact of Chromium, Phyllanthus Emblica, and Shilajit on Cardiovascular Health, Fitness, and Weight Loss During Exercise and Diet Programs
A study testing Cr-400, Cr-800 and PE-500 in people with Overweight and Metabolic Syndrome X, run by Kerry Group P.L.C at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Metabolic Syndrome X
- What is being tested?
- Cr-400, Cr-800 and PE-500
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 29 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Overweight, Metabolic Syndrome X
- Being tested
- Placebo, Cr-400, Cr-800, PE-500, PE-1000
- Medical subject headings
- Overweight, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
PE-500Dietary supplement
1 capsule of PE + 1 capsule of Placebo, once a day after breakfast for 12 weeks
PE-1000Dietary supplement
2 capsules of PE-500, once a day after breakfast for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 2 x 500 mg capsules Receives: Dietary Supplement: Placebo |
| Dietary Supplement 1 | Experimental | 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 Receives: Dietary Supplement: Cr-400 |
| Dietary Supplement 2 | Experimental | 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) Receives: Dietary Supplement: Cr-800 |
| Dietary Supplement 3 | Experimental | 1 x 500 mg capsule of PE (500mg) + 1 x 500 mg capsule of PLA Receives: Dietary Supplement: PE-500 |
| Dietary Supplement 4 | Experimental | 2 x 500 mg capsules of PE (1000 mg) Receives: Dietary Supplement: PE-1000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow-Mediated Dilation (FMD)
Percentage of change in the Flow-Mediated Dilation (FMD).
Measured: Baseline, 6 and 12 weeks
Venous Occlusion (VO)
Changes in the Venous Occlusion (VO) for the FMD cuff: mmHg
Measured: Baseline, 6 and 12 weeks
Platelet Aggregation
Check participants' Platelet Aggregation (Ohms)
Measured: Baseline, 6 and 12 weeks
Fasting Glucose
To assess changes in participants' levels of fasting glucose (mg/dL)
Measured: Baseline, 6 and 12 weeks
HbA1c
To assess changes in the concentration of HbA1c (mmol/mol)
Measured: Baseline, 6 and 12 weeks
C-reactive protein (CRP)
To assess changes in the level of CRP (mg/L)
Measured: Baseline, 6 and 12 weeks
Lipid Profile-Cholesterol
Changes in the level of cholesterol (mg/dL)
Measured: Baseline, 6 weeks and 12 weeks
Lipid Profile -Triglycerides
Changes in the level of Triglycerides (mg/dL)
Measured: Baseline, 6 weeks and 12 weeks
Lipid Profile- HDL Cholesterol
Changes in the level of HDL Cholesterol (mg/dL)
Measured: Baseline, 6 and 12 weeks
Lipid Profile- LDL Cholesterol
Changes in the level of LDL Cholesterol (mg/dL)
Measured: Baseline, 6 and 12 weeks
Lipid Profile- Calculated VLDL Cholesterol
Changes in the Calculated VLDL Cholesterol (mg/dL)
Measured: Baseline, 6 and 12 weeks
Lipid Profile- Risk Ratio (LDL/HDL)
Changes in the Risk Ratio (LDL/HDL)
Measured: Baseline, 6 and 12 weeks
Lipid Profile- Risk Ratio (Cholesterol/HDL)
Changes in Risk Ratio (Cholesterol/HDL)
Measured: Baseline, 6 and 12 weeks
Secondary outcomes (28)
Resting Energy Expenditure
Assessment of the Resting Energy Expenditure (REE) (kcal/day)
Measured: Baseline, 6 and 12 weeks
Resting Hemodynamics- blood pressure
Blood pressure will be assessed before the exercise test (mmHg)
Measured: Baseline, 6 and 12 weeks
Resting Hemodynamics-Weight
Weight (kg) will be taken before the exercise test
Measured: Baseline, 6 and 12 weeks
Resting hemodynamics- Height
Height (m) will be taken before the exercise test
Measured: Baseline, 6 and 12 weeks
Resting hemodynamics- Fat loss
Assessment of fat loss (kg)
Measured: Baseline, 6 and 12 weeks
Maximal Aerobic Capacity
Milliliters of oxygen per kilogram of body weight per minute (mL/kg/min)
Measured: Baseline, 6 and 12 weeks
Musculoskeletal Strength
One Repetition Maximum (1 RM) in pounds (lbs)
Measured: Baseline, 6 and 12 weeks
Musculoskeletal Endurance
Number of Repetitions (#) at a given percentage of 1RM in pounds (lbs.)
Measured: 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
Measured: Baseline, 6 and 12 weeks
Inflammatory Markers- Aspartate Aminotransferase (AST)
Changes in the level of Aspartate Aminotransferase : U/L
Measured: Baseline, 6 and 12 weeks
Inflammatory markers- Alanine Transaminase (ALT)
Changes in the level of Alanine Transaminase (ALT): U/L
Measured: Baseline, 6 and 12 weeks
Inflammatory markers- Blood Urea Nitrogen (BUN)
Changes in the level of Blood Urea Nitrogen (BUN)
Measured: Baseline, 6 and 12 weeks
Inflammatory markers- Creatinine
Changes in the creatinine level (mg/dL)
Measured: Baseline, 6 and 12 weeks
Inflammatory markers- BUN/Creatine Ratio
Changes in the BUN/Creatine Ratio (Ratio)
Measured: 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).
Measured: Baseline, 6 and 12 weeks
Metabolic Panel- Sodium
Changes in Sodium level (MEQ/L)
Measured: Baseline, 6 and 12 weeks
Metabolic Panel- Potassium
Changes in Potassium level (MEQ/L)
Measured: Baseline, 6 and 12 weeks
Metabolic Panel-Chloride
Changes in Chloride level (MEQ/L)
Measured: Baseline, 6 and 12 weeks
Metabolic Panel- Carbon Dioxide
Changes in the level of Carbon Dioxide (MEQ/L)
Measured: Baseline, 6 and 12 weeks
Metabolic Panel- Calcium
Changes in the level of calcium (mg/dL)
Measured: Baseline, 6 and 12 weeks
Metabolic Panel-Protein
Changes in the Total level of Protein (g/dL)
Measured: Baseline, 6 and 12 weeks
Metabolic Panel- Albumin
Changes in the level of Albumin ( g/dL)
Measured: Baseline, 6 and 12 weeks
Metabolic Panel- Globulin
changes in the level globulin (g/dL)
Measured: Baseline, 6 and 12 weeks
Metabolic Panel- Bilirubin
Changes in the total level of Bilirubin (mg/dL)
Measured: Baseline, 6 and 12 weeks
Metabolic Panel- Alkaline Phosphatase
Changes in the level of Alkaline Phosphatase U/L
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Feb 2019
- Primary completion30 Jan 2024
- Study completion29 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 24 participants per group equally comprised of men and women matched as closely as possible by age, gender, BMI, and body mass
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kerry Group P.L.C
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641596
- Sponsor's protocol ID
- S23-1467336
- Status last verified
- Oct 2024
- First submitted
- 11 Sep 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Martinez V, McAngus K, Dickerson BL, Leonard M, Chavez E, Chun J, Lewis M, Xing D, Gonzalez DE, Yoo C, Ko J, Rhodes H, Lee H, Sowinski RJ, Rasmussen CJ, Kreider RB. Effects of 12 Weeks of Chromium, Phyllanthus emblica Fruit Extract, and Shilajit Supplementation on Markers of Cardiometabolic Health, Fitness, and Weight Loss in Men and Women with Risk Factors to Metabolic Syndrome Initiating an Exercise and Diet Intervention: A Randomized Double-Blind, Placebo-Controlled Trial. Nutrients. 2025 Jun 19;17(12):2042. doi: 10.3390/nu17122042.
PubMed 40573153
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06641596
- Acronym / sponsor ID
- S23-1467336
- Conditions
- Overweight, Metabolic Syndrome X
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Kerry Group P.L.CIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 29 May 2024 (actual)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- 24 participants per group equally comprised of men and women matched as closely as possible by age, gender, BMI, and body mass
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo2 x 500 mg capsules |
| Dietary Supplement 1 | Experimental | Dietary Supplement: Cr-4001 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 2 | Experimental | Dietary Supplement: Cr-8002 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 3 | Experimental | Dietary Supplement: PE-5001 x 500 mg capsule of PE (500mg) + 1 x 500 mg capsule of PLA |
| Dietary Supplement 4 | Experimental | Dietary Supplement: PE-10002 x 500 mg capsules of PE (1000 mg) |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo2 capsules of Placebo, once daily after breakfast for 12 weeks | Dietary supplement | Placebo |
| Cr-4001 capsule of Cr-400 + 1 capsule of Placebo, once a day after breakfast for 12 weeks | Dietary supplement | Dietary Supplement 1 |
| Cr-8002 capsules of Cr-400, once a day after breakfast for 12 weeks | Dietary supplement | Dietary Supplement 2 |
| PE-5001 capsule of PE + 1 capsule of Placebo, once a day after breakfast for 12 weeks | Dietary supplement | Dietary Supplement 3 |
| PE-10002 capsules of PE-500, once a day after breakfast for 12 weeks | Dietary supplement | Dietary Supplement 4 |
Primary outcome
Flow-Mediated Dilation (FMD)
Time frame: Baseline, 6 and 12 weeks
Percentage of change in the Flow-Mediated Dilation (FMD).
Venous Occlusion (VO)
Time frame: Baseline, 6 and 12 weeks
Changes in the Venous Occlusion (VO) for the FMD cuff: mmHg
Platelet Aggregation
Time frame: Baseline, 6 and 12 weeks
Check participants' Platelet Aggregation (Ohms)
Fasting Glucose
Time frame: Baseline, 6 and 12 weeks
To assess changes in participants' levels of fasting glucose (mg/dL)
HbA1c
Time frame: Baseline, 6 and 12 weeks
To assess changes in the concentration of HbA1c (mmol/mol)
C-reactive protein (CRP)
Time frame: Baseline, 6 and 12 weeks
To assess changes in the level of CRP (mg/L)
Lipid Profile-Cholesterol
Time frame: Baseline, 6 weeks and 12 weeks
Changes in the level of cholesterol (mg/dL)
Lipid Profile -Triglycerides
Time frame: Baseline, 6 weeks and 12 weeks
Changes in the level of Triglycerides (mg/dL)
Lipid Profile- HDL Cholesterol
Time frame: Baseline, 6 and 12 weeks
Changes in the level of HDL Cholesterol (mg/dL)
Lipid Profile- LDL Cholesterol
Time frame: Baseline, 6 and 12 weeks
Changes in the level of LDL Cholesterol (mg/dL)
Lipid Profile- Calculated VLDL Cholesterol
Time frame: Baseline, 6 and 12 weeks
Changes in the Calculated VLDL Cholesterol (mg/dL)
Lipid Profile- Risk Ratio (LDL/HDL)
Time frame: Baseline, 6 and 12 weeks
Changes in the Risk Ratio (LDL/HDL)
Lipid Profile- Risk Ratio (Cholesterol/HDL)
Time frame: Baseline, 6 and 12 weeks
Changes in Risk Ratio (Cholesterol/HDL)
28 secondary outcomes
Resting Energy Expenditure
Time frame: Baseline, 6 and 12 weeks
Resting Hemodynamics- blood pressure
Time frame: Baseline, 6 and 12 weeks
Resting Hemodynamics-Weight
Time frame: Baseline, 6 and 12 weeks
Resting hemodynamics- Height
Time frame: Baseline, 6 and 12 weeks
Resting hemodynamics- Fat loss
Time frame: Baseline, 6 and 12 weeks
Maximal Aerobic Capacity
Time frame: Baseline, 6 and 12 weeks
Musculoskeletal Strength
Time frame: Baseline, 6 and 12 weeks
Musculoskeletal Endurance
Time frame: Baseline, 6 and 12 weeks
Inflammatory Markers- High Sensitivity C Reactive Protein
Time frame: Baseline, 6 and 12 weeks
Inflammatory Markers- Aspartate Aminotransferase (AST)
Time frame: Baseline, 6 and 12 weeks
Inflammatory markers- Alanine Transaminase (ALT)
Time frame: Baseline, 6 and 12 weeks
Inflammatory markers- Blood Urea Nitrogen (BUN)
Time frame: Baseline, 6 and 12 weeks
Inflammatory markers- Creatinine
Time frame: Baseline, 6 and 12 weeks
Inflammatory markers- BUN/Creatine Ratio
Time frame: Baseline, 6 and 12 weeks
Complete Blood Count (CBC)
Time frame: Baseline, 6 and 12 weeks
Metabolic Panel- Sodium
Time frame: Baseline, 6 and 12 weeks
Metabolic Panel- Potassium
Time frame: Baseline, 6 and 12 weeks
Metabolic Panel-Chloride
Time frame: Baseline, 6 and 12 weeks
Metabolic Panel- Carbon Dioxide
Time frame: Baseline, 6 and 12 weeks
Metabolic Panel- Calcium
Time frame: Baseline, 6 and 12 weeks
Metabolic Panel-Protein
Time frame: Baseline, 6 and 12 weeks
Metabolic Panel- Albumin
Time frame: Baseline, 6 and 12 weeks
Metabolic Panel- Globulin
Time frame: Baseline, 6 and 12 weeks
Metabolic Panel- Bilirubin
Time frame: Baseline, 6 and 12 weeks
Metabolic Panel- Alkaline Phosphatase
Time frame: Baseline, 6 and 12 weeks
Profile of Mood States (POMS)
Time frame: Baseline, 6 and 12 weeks
Quality of Life Assessment (QOL)
Time frame: Baseline, 6 and 12 weeks
Cognitive function measures
Time frame: Baseline, 6 weeks and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Derived from this study: PubMed 40573153Martinez V, McAngus K, Dickerson BL, Leonard M, Chavez E, Chun J, Lewis M, Xing D, Gonzalez DE, Yoo C, Ko J, Rhodes H, Lee H, Sowinski RJ, Rasmussen CJ, Kreider RB. Effects of 12 Weeks of Chromium, Phyllanthus emblica Fruit Extract, and Shilajit Supplementation on Markers of Cardiometabolic Health, Fitness, and Weight Loss in Men and Women with Risk Factors to Metabolic Syndrome Initiating an Exercise and Diet Intervention: A Randomized Double-Blind, Placebo-Controlled Trial. Nutrients. 2025 Jun 19;17(12):2042. doi: 10.3390/nu17122042.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cr-400, Cr-800 and PE-500 in people with Overweight and Metabolic Syndrome X, run by Kerry Group P.L.C at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flow-Mediated Dilation (FMD) (time frame: Baseline, 6 and 12 weeks). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06641596, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.