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.
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
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
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 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Supplement Formulators, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Swick, Ph.D, Principal investigator, LIfe Extension
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 9832077Alberti 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 16182882Ali, 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 15464923Anton 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 24866496Benjamin 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 30700139Berman 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 28989978Bunker 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 17571945Burton-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 22331646Csige 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 30525052Carrier 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 27796142Carr 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 15277390Chen 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 23631493Cheng 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 22917016Clark 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.
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.
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.
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
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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.
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.