Oxidized Low Density LipoproteinNCT04317287

To Assess the Efficacy and Safety of the Cardio Formulation in Reducing Oxidized LDL

A study testing Cardio formulation in people with Oxidized Low Density Lipoprotein, run by Supplement Formulators, Inc. at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

The purpose of this study is to assess the efficacy and safety of the Cardio formulation in reducing oxidized LDL [(Ox LDL (low density lipoprotein)] in overweight to mildly obese generally healthy adults. Read more about this study

Who is it for?: Ages 40 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Oxidized Low Density Lipoprotein
What is being tested?: Cardio formulation
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 9 participants
Where: 1 siteUnited States
Study dates: 10 Dec 2019to 19 Nov 2021
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 40 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Ambulatory, male or female, 40-75 years of age
A BMI of 25-34.9 and/or waist circumference > 40.0 inches in males and > 35.0 inches in females
Having a fasting LDL cholesterol level of >100- <189 mg/dL OR, total cholesterol level of > 200-< 239 mg/dL OR triglycerides level of > 150 mg/dl - < 199 mg/dl OR blood sugar level > 100 mg/dl - < 126 mg/dl based upon the screening laboratory results from the Complete Blood Count (CBC)/Chemistry profile
Generally healthy and having no significant difficulty with digestion or absorption of food
Has been generally weight stable for the past six months (+ 6 lbs.)
Willing and able to give written informed consent

Show all 10Show fewer

Clearly understands the procedures and study requirements
Willing and able to comply with all study procedures, including following the recommendations to maintain their usual diet and regular activity, as per protocol
Able to communicate, including reading, in English
Have not taken any nutritional supplements that may contain any of the components of the study product for a minimum of 14 days before Screening/baseline

Who cannot join

Having smoked any cigarette, electronic cigarette, cigar, pipe, or used a recreational drug or any product containing cannabidiol (CBD) or tetrahydrocannabinol (THC) in the past 30 days
Donated blood within 30 days before Screening/baseline
Inability to provide a venous blood sample
Participation in another study within 30 days prior to Screening/baseline
Being pregnant or planning on becoming pregnant during study participation; or breast feeding
History of allergy or sensitivity to any component of the study products including tomatoes, lycopene, Japanese knotweed (Reynoutria japonica, Fallopia japonica, Polygonum cuspidatum) phytosterols, mixed tocopherols, phytoene and phytofluene and beta carotene, polydatin, resveratrol, gelatin, glycerin, or coconut oil

Show all 33Show fewer

Currently taking or having taken within 30 days before Screening/baseline a cholesterol-lowering medication(s) including 3-hydroxy-3-methylglutaric acid-CoA (HMG-CoA) reductase inhibitors, cholesterol binding resins, niacin > 500 mg/day, or fibrates
Currently taking or having taken within 30 days before Screening/baseline a dietary supplement/food that may affect cholesterol levels including niacin > 500 mg/day, red yeast rice, red mold dioscorea, guggulipid, policosanol, pantethine > 300 mg/day, beta-sitosterol, artichoke leaf, L-carnitine, and nuts (including almonds, walnuts, hazelnuts, pecans and pistachios > 1oz. per day)
Currently taking or having taken within 30 days before Screening/baseline a multivitamin/mineral product (unless on a consistent daily intake and unlikely to change during the study period)
Currently taking or having taken within 30 days before Screening/baseline a supplemental fiber product (unless on a consistent daily intake and unlikely to change during the study period)
Presence of active or recurring clinically significant conditions as follows:
Diabetes mellitus or other endocrine disease
Eating disorder
Acute or chronic inflammatory disease or autoimmune disease
Cardiovascular disease including heart and blood vessel disease, arrhythmia, heart attack, stroke or heart valve problem
Gastrointestinal disease including gallbladder problems, gallstones or biliary tract obstruction
Thyroid disease (unless on a stable dose of medication for 3 months before Screening/baseline and unlikely to change medication or dose during the study period)
Hypertension (unless on a stable dose of medication for 3 months before Screening/baseline and unlikely to change medication or dose during the study period)
Neurologic condition/disease
Cancer (unless skin cancer other than melanoma which has been treated > 3 years before Screening/baseline)
Liver, pancreatic, and kidney disease
Pulmonary disease
Blood coagulation disorder or other hematologic disease
Other condition or medication use that would preclude participation in the study in the judgment of the Study Investigator/sub-investigator (Sub-I)
Currently taking any medication(s) or treatment for a psychiatric disorder (bipolar disorder, manic disorder, schizophrenia, apathetic [inherited] disorder) that include antidepressant drugs, including selective serotonin reuptake inhibitors (SSRIs), tricyclic and atypical antidepressants; benzodiazepines; CNS depressants dextromethorphan, meperidine, monoamine oxidase inhibitors (MAOIs); pentazocine, phenothiazines and tramadol. These may preclude participation in the study dependent on the judgment of the investigator/sub-investigator.
Currently taking or having taken within the 30 days before Screening/baseline any hormone replacement therapy (including dehydroepiandrosterone (DHEA), estrogen, progesterone, or testosterone; except those utilized as a method of birth control and which have been taken for > 3 months, with no anticipated change for the duration of the study period)
Having had a surgical procedure or having an internal medical device which, in the judgment of the Study Investigator/Sub-I, would preclude participation in the study
Having abnormal screening laboratory test values including bilirubin > 2.5 x upper limit of normal (ULN), aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT) /serum glutaminic- pyruvic transaminase (SGPT) > 2.5 x ULN, serum creatinine > 1.5 mg/dL based upon the screening laboratory results or other lab test result(s) that would preclude study participation in the judgement of the Study Investigator/Sub-I
Having blood pressure readings at Screening/baseline > 140 systolic or > 90 diastolic on two consecutive readings unless permitted to proceed to the next visit in the judgment of the Study Investigator/Sub-I
Currently consumes more than 7 standard alcoholic drinks per week for women and 14 drinks per week for men (a standard alcoholic drink is defined as one bottle/can of beer, one glass of wine, or one ounce of hard liquor)
Unable or unwilling to avoid consuming grapefruit juice or fresh grapefruit, Seville oranges and tangelos
History of known or suspected substance abuse (e.g., alcohol, opiates, benzodiazepines or amphetamines).
Having any other circumstance that precludes study participation in the judgment of the Study Investigator/Sub-I, including use of other nutritional supplements, which will be evaluated on a case-by-case basis.

Trial locations and contacts

1 site in 1 country.

United States1 site

Lfie Extension Clinical Reseach, Inc.
Fort Lauderdale, Florida, 33308

Other trials in United States

About this study

Official title: A Double-blind, Randomized, Placebo-controlled, Parallel Design Study to Evaluate the Effects of the Cardio Formulation on Oxidized LDL in Individuals Who Are Overweight to Mildly Obese and Otherwise Healthy

Read the detailed description

This is a double-blind, randomized, placebo-controlled, parallel design study to evaluate the effectiveness of the Cardio formulation in reducing oxidized LDL. Each subject will receive a specific dose of the study product to be taken with a meal daily preferably at the same time each day with water.

Participants will receive questionnaires, assessments, blood tests, vital signs and body composition analysis.

The primary objective is the evaluation of the change in Ox LDL in response to the Cardio formulation at Days 30 and 60 relative to baseline compared with placebo.

The secondary objective is the evaluation of the change in anthropometric measurements, clinical laboratory evaluations, and health survey scores in response to the Cardio formulation at Days 30 and Day 60 relative to baseline compared with placebo.

Conditions: Oxidized Low Density Lipoprotein
Being tested: Cardio formulation, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cardio formulationDietary supplement
Tomato-based formulation with dietary supplement softgels
PlaceboDietary supplement
Placebo softgels

Study groups in NCT04317287
Study group	Role	What they receive
Cardio formulation	Experimental	Tomato-based formulation with dietary supplement Receives: Dietary Supplement: Cardio formulation
Placebo	Placebo comparator	Placebo softgels Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Assessment of the mean or median change in Oxidized LDL relative to baseline
Mean or median change in Oxidized LDL from baseline to Day 60
Measured: 60 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Dec 201919 Nov 2021

First posted23 Mar 2020
Study start10 Dec 2019
Primary completion19 Nov 2021
Study completion19 Nov 2021

Why it stopped: COVID-19 Pandemic

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (53)Papers the sponsor has linked to this study.
Other trials for Oxidized Low Density LipoproteinStudies 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: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04317287
Sponsor's protocol ID: CL099
Status last verified: Jan 2023
First submitted: 19 Mar 2020
Last updated: 13 Jan 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Agarwal S, Rao AV. Tomato lycopene and low density lipoprotein oxidation: a human dietary intervention study. Lipids. 1998 Oct;33(10):981-4. doi: 10.1007/s11745-998-0295-6.
PubMed 9832077
Alberti KG, Zimmet P, Shaw J; IDF Epidemiology Task Force Consensus Group. The metabolic syndrome--a new worldwide definition. Lancet. 2005 Sep 24-30;366(9491):1059-62. doi: 10.1016/S0140-6736(05)67402-8. No abstract available.
PubMed 16182882
Ali, W., Kushwaha, U., Wamique, M., & et al. (2017). Oxidized LDL as a Biomarker in Metabolic Syndrome. J Diabetes Metab, 8(9), 1-5.
Ansari MS, Gupta NP. Lycopene: a novel drug therapy in hormone refractory metastatic prostate cancer. Urol Oncol. 2004 Sep-Oct;22(5):415-20. doi: 10.1016/j.urolonc.2004.05.009.
PubMed 15464923
Anton SD, Embry C, Marsiske M, Lu X, Doss H, Leeuwenburgh C, Manini TM. Safety and metabolic outcomes of resveratrol supplementation in older adults: results of a twelve-week, placebo-controlled pilot study. Exp Gerontol. 2014 Sep;57:181-7. doi: 10.1016/j.exger.2014.05.015. Epub 2014 May 24.
PubMed 24866496
Benjamin EJ, Muntner P, Alonso A, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Das SR, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Jordan LC, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, O'Flaherty M, Pandey A, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Spartano NL, Stokes A, Tirschwell DL, Tsao CW, Turakhia MP, VanWagner LB, Wilkins JT, Wong SS, Virani SS; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2019 Update: A Report From the American Heart Association. Circulation. 2019 Mar 5;139(10):e56-e528. doi: 10.1161/CIR.0000000000000659. No abstract available.
PubMed 30700139
Berman AY, Motechin RA, Wiesenfeld MY, Holz MK. The therapeutic potential of resveratrol: a review of clinical trials. NPJ Precis Oncol. 2017;1:35. doi: 10.1038/s41698-017-0038-6. Epub 2017 Sep 25.
PubMed 28989978
Bunker CH, McDonald AC, Evans RW, de la Rosa N, Boumosleh JM, Patrick AL. A randomized trial of lycopene supplementation in Tobago men with high prostate cancer risk. Nutr Cancer. 2007;57(2):130-7. doi: 10.1080/01635580701274046.
PubMed 17571945
Burton-Freeman B, Talbot J, Park E, Krishnankutty S, Edirisinghe I. Protective activity of processed tomato products on postprandial oxidation and inflammation: a clinical trial in healthy weight men and women. Mol Nutr Food Res. 2012 Apr;56(4):622-31. doi: 10.1002/mnfr.201100649. Epub 2012 Feb 14.
PubMed 22331646
Csige I, Ujvarosy D, Szabo Z, Lorincz I, Paragh G, Harangi M, Somodi S. The Impact of Obesity on the Cardiovascular System. J Diabetes Res. 2018 Nov 4;2018:3407306. doi: 10.1155/2018/3407306. eCollection 2018.
PubMed 30525052
Carrier A. Metabolic Syndrome and Oxidative Stress: A Complex Relationship. Antioxid Redox Signal. 2017 Mar 20;26(9):429-431. doi: 10.1089/ars.2016.6929. Epub 2016 Dec 19.
PubMed 27796142
Carr DB, Utzschneider KM, Hull RL, Kodama K, Retzlaff BM, Brunzell JD, Shofer JB, Fish BE, Knopp RH, Kahn SE. Intra-abdominal fat is a major determinant of the National Cholesterol Education Program Adult Treatment Panel III criteria for the metabolic syndrome. Diabetes. 2004 Aug;53(8):2087-94. doi: 10.2337/diabetes.53.8.2087.
PubMed 15277390
Chen J, Song Y, Zhang L. Effect of lycopene supplementation on oxidative stress: an exploratory systematic review and meta-analysis of randomized controlled trials. J Med Food. 2013 May;16(5):361-74. doi: 10.1089/jmf.2012.2682. Epub 2013 Apr 30.
PubMed 23631493
Cheng AS, Cheng YH, Chiou CH, Chang TL. Resveratrol upregulates Nrf2 expression to attenuate methylglyoxal-induced insulin resistance in Hep G2 cells. J Agric Food Chem. 2012 Sep 12;60(36):9180-7. doi: 10.1021/jf302831d. Epub 2012 Aug 29.
PubMed 22917016
Clark PE, Hall MC, Borden LS Jr, Miller AA, Hu JJ, Lee WR, Stindt D, D'Agostino R Jr, Lovato J, Harmon M, Torti FM. Phase I-II prospective dose-escalating trial of lycopene in patients with biochemical relapse of prostate cancer after definitive local therapy. Urology. 2006 Jun;67(6):1257-61. doi: 10.1016/j.urology.2005.12.035.
PubMed 16765186

Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Randomized, Placebo-controlled, Parallel Design Study to Evaluate the Effects of the Cardio Formulation on Oxidized LDL in Individuals Who Are Overweight to Mildly Obese and Otherwise Healthy
ClinicalTrials.gov ID: NCT04317287
Acronym / sponsor ID: CL099
Conditions: Oxidized Low Density Lipoprotein
Study type: Interventional
Recruitment status: TerminatedReason stopped: COVID-19 Pandemic
Enrolment: 9 participants (actual)
Lead sponsor: Supplement Formulators, Inc.Industry (pharma, biotech, devices)
Study start: 10 Dec 2019 (actual)
Primary completion: 19 Nov 2021 (actual)
Study completion: 19 Nov 2021 (actual)
First posted: 23 Mar 2020 (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.

Detailed description

Participants will receive questionnaires, assessments, blood tests, vital signs and body composition analysis.

The primary objective is the evaluation of the change in Ox LDL in response to the Cardio formulation at Days 30 and 60 relative to baseline compared with placebo.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Cardio formulation	Experimental	Dietary Supplement: Cardio formulationTomato-based formulation with dietary supplement
Placebo	Placebo comparator	Dietary Supplement: PlaceboPlacebo softgels

Who may qualify

Ages: 40 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Ambulatory, male or female, 40-75 years of age
A BMI of 25-34.9 and/or waist circumference > 40.0 inches in males and > 35.0 inches in females
Having a fasting LDL cholesterol level of >100- <189 mg/dL OR, total cholesterol level of > 200-< 239 mg/dL OR triglycerides level of > 150 mg/dl - < 199 mg/dl OR blood sugar level > 100 mg/dl - < 126 mg/dl based upon the screening laboratory results from the Complete Blood Count (CBC)/Chemistry profile
Generally healthy and having no significant difficulty with digestion or absorption of food
Has been generally weight stable for the past six months (+ 6 lbs.)

Key exclusion criteria (33 listed)

Having smoked any cigarette, electronic cigarette, cigar, pipe, or used a recreational drug or any product containing cannabidiol (CBD) or tetrahydrocannabinol (THC) in the past 30 days
Donated blood within 30 days before Screening/baseline
Inability to provide a venous blood sample
Participation in another study within 30 days prior to Screening/baseline
Being pregnant or planning on becoming pregnant during study participation; or breast feeding

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
Cardio formulationTomato-based formulation with dietary supplement softgels	Dietary supplement	Cardio formulation
PlaceboPlacebo softgels	Dietary supplement	Placebo

Primary outcome

Assessment of the mean or median change in Oxidized LDL relative to baseline
Time frame: 60 days
Mean or median change in Oxidized LDL from baseline to Day 60

Results and safety

The study was stopped early (reason given: COVID-19 Pandemic). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
Background: PubMed 9832077Agarwal S, Rao AV. Tomato lycopene and low density lipoprotein oxidation: a human dietary intervention study. Lipids. 1998 Oct;33(10):981-4. doi: 10.1007/s11745-998-0295-6.
Background: PubMed 16182882Alberti KG, Zimmet P, Shaw J; IDF Epidemiology Task Force Consensus Group. The metabolic syndrome--a new worldwide definition. Lancet. 2005 Sep 24-30;366(9491):1059-62. doi: 10.1016/S0140-6736(05)67402-8. No abstract available.
BackgroundAli, W., Kushwaha, U., Wamique, M., & et al. (2017). Oxidized LDL as a Biomarker in Metabolic Syndrome. J Diabetes Metab, 8(9), 1-5.
Background: PubMed 15464923Ansari MS, Gupta NP. Lycopene: a novel drug therapy in hormone refractory metastatic prostate cancer. Urol Oncol. 2004 Sep-Oct;22(5):415-20. doi: 10.1016/j.urolonc.2004.05.009.
Background: PubMed 24866496Anton SD, Embry C, Marsiske M, Lu X, Doss H, Leeuwenburgh C, Manini TM. Safety and metabolic outcomes of resveratrol supplementation in older adults: results of a twelve-week, placebo-controlled pilot study. Exp Gerontol. 2014 Sep;57:181-7. doi: 10.1016/j.exger.2014.05.015. Epub 2014 May 24.
Background: PubMed 30700139Benjamin EJ, Muntner P, Alonso A, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Das SR, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Jordan LC, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, O'Flaherty M, Pandey A, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Spartano NL, Stokes A, Tirschwell DL, Tsao CW, Turakhia MP, VanWagner LB, Wilkins JT, Wong SS, Virani SS; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2019 Update: A Report From the American Heart Association. Circulation. 2019 Mar 5;139(10):e56-e528. doi: 10.1161/CIR.0000000000000659. No abstract available.
Background: PubMed 28989978Berman AY, Motechin RA, Wiesenfeld MY, Holz MK. The therapeutic potential of resveratrol: a review of clinical trials. NPJ Precis Oncol. 2017;1:35. doi: 10.1038/s41698-017-0038-6. Epub 2017 Sep 25.
Background: PubMed 17571945Bunker CH, McDonald AC, Evans RW, de la Rosa N, Boumosleh JM, Patrick AL. A randomized trial of lycopene supplementation in Tobago men with high prostate cancer risk. Nutr Cancer. 2007;57(2):130-7. doi: 10.1080/01635580701274046.
Background: PubMed 22331646Burton-Freeman B, Talbot J, Park E, Krishnankutty S, Edirisinghe I. Protective activity of processed tomato products on postprandial oxidation and inflammation: a clinical trial in healthy weight men and women. Mol Nutr Food Res. 2012 Apr;56(4):622-31. doi: 10.1002/mnfr.201100649. Epub 2012 Feb 14.
Background: PubMed 30525052Csige I, Ujvarosy D, Szabo Z, Lorincz I, Paragh G, Harangi M, Somodi S. The Impact of Obesity on the Cardiovascular System. J Diabetes Res. 2018 Nov 4;2018:3407306. doi: 10.1155/2018/3407306. eCollection 2018.
Background: PubMed 27796142Carrier A. Metabolic Syndrome and Oxidative Stress: A Complex Relationship. Antioxid Redox Signal. 2017 Mar 20;26(9):429-431. doi: 10.1089/ars.2016.6929. Epub 2016 Dec 19.
Background: PubMed 15277390Carr DB, Utzschneider KM, Hull RL, Kodama K, Retzlaff BM, Brunzell JD, Shofer JB, Fish BE, Knopp RH, Kahn SE. Intra-abdominal fat is a major determinant of the National Cholesterol Education Program Adult Treatment Panel III criteria for the metabolic syndrome. Diabetes. 2004 Aug;53(8):2087-94. doi: 10.2337/diabetes.53.8.2087.
Individual participant dataSharing planned: No

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.

Andrew Swick, Ph.D principal investigator

LIfe Extension

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Cardio formulation in people with Oxidized Low Density Lipoprotein, run by Supplement Formulators, Inc. 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 10 inclusion and 33 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: stopped early, as of the sponsor's last update on 13 Jan 2023. 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 was stopped early (reason given: COVID-19 Pandemic). Results are not available in the source record.

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?

Assessment of the mean or median change in Oxidized LDL relative to baseline (time frame: 60 days). 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 NCT04317287, which also lists 53 linked publications.

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 13 Jan 2023; AzTrials last refreshed its copy on 8 Nov 2026.