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| Name | Class |
|---|---|
| Texas Diabetes & Endocrinology, P.A. | OTHER |
| Utah State University | OTHER |
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This open label study seeks to study the effects of a nutritional supplement on inflammatory markers, metabolic parameters, and safety in subjects compared to baseline after taking supplement for 2 and 4 months.
Primary endpoint will be to determine if nutritional supplement decreases the metabolic parameter of triglycerides. Numerous studies have demonstrated the efficacy of fish oil on reducing triglycerides in subjects taking fish oil at similar doses provided in our product (see references).
Additional metabolic parameters will be measured as secondary endpoints, including abdominal obesity, HDL cholesterol, blood pressure, fasting glucose, haemoglobin A1c, skin glycation (AGEs), pulse wave velocity, skin carotenoids, serum 25(OH)D concentrations, weight, and LDL density, particle size and number. The novel nutritional supplement contains many nutrients that have been shown to improve metabolic parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutritional Supplement Blend | Experimental | The nutritional supplement contains a proprietary blend consisting of 15 unique nutritional ingredients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutritional Supplement Blend | Dietary Supplement | It is to be taken orally at a dose of 4 capsules per day, 2 capsules with breakfast and 2 capsules with dinner. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Serum Triglycerides at 2 months and 4 months | Baseline, 2 months, 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Abdominal Obesity at 2 months and 4 months | Baseline, 2 months, 4 months | |
| Change from Baseline in HDL cholesterol at 2 months and 4 months | Baseline, 2 months, 4 months | |
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Inclusion Criteria:
Subject male or female between the ages of 30-70 at the time of informed consent.
Fasting Blood Glucose between 90 and 125mg/dL in the serum and 2 additional parameters at screening:
Hemoglobin A1C less than 6.5% at screening
BMI >27kg/m2
Blood Pressure <150/90 mm Hg
Subject is willing and able to comply with study restrictions, procedures, and assessments.
Subject is able to swallow product without difficulty.
Subject is willing to fast for 8h prior to blood draw at screening, baseline, 2 month, and 4 month visits.
Subject is willing to maintain usual diet and physical activity for the duration of the study.
Eats 1 or fewer servings of fatty fish per week (e.g. salmon, tuna, mackerel, herring, anchovies, etc.)
Subject is willing to take the study multi-vitamin/mineral supplement for 30 days prior to starting investigational product and during the 4 month intake of investigational product.
Use of effective method of contraception by females of childbearing potential 30-days before the screening visit and agree to continue to practice that acceptable method of contraception for the duration of her participation in the study. Acceptable methods of contraception include oral, injectable, or implantable contraceptives; intrauterine devices, diaphragm plus spermicide; abstinence (must agree to use double-barrier method if they become sexually active), transdermal patch, or any double barrier method including a vasectomized sexual partner. Women who have had a hysterectomy (partial or total) or tubal ligation at least 6 months prior to Visit 1 or who have been post-menopausal for at least 1 year prior to Visit 1 are not considered to be of childbearing potential.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Blevins, MD | Founder | Principal Investigator |
| Michael Lefevre, PhD | Scientific Director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Diabetes & Endocrinology | Austin | Texas | 78731 | United States | ||
| Utah State University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18757090 | Background | Tavazzi L, Maggioni AP, Marchioli R, Barlera S, Franzosi MG, Latini R, Lucci D, Nicolosi GL, Porcu M, Tognoni G; Gissi-HF Investigators. Effect of n-3 polyunsaturated fatty acids in patients with chronic heart failure (the GISSI-HF trial): a randomised, double-blind, placebo-controlled trial. Lancet. 2008 Oct 4;372(9645):1223-30. doi: 10.1016/S0140-6736(08)61239-8. Epub 2008 Aug 29. | |
| 22811376 |
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| Change from Baseline in Fasting glucose at 2 months and 4 months |
| Baseline, 2 months, 4 months |
| Change from Baseline in Total cholesterol at 2 months and 4 months | Baseline, 2 months, 4 months |
| Change from Baseline in LDL density, particle size, and number at 2 months and 4 months | Baseline, 2 months, 4 months |
| Change from Baseline in Hemoglobin A1c at 2 months and 4 months | Baseline, 2 months, 4 months |
| Change from Baseline in Skin glycation (AGEs) at 2 months and 4 months | Baseline, 2 months, 4 months |
| Change from Baseline in Pulse wave velocity measurements at 2 months and 4 months | Baseline, 2 months, 4 months |
| Change from Baseline in Erythrocyte sedimentation rate at 2 months and 4 months | Baseline, 2 months, 4 months |
| Change from Baseline in Cytokine and additional markers at 2 months and 4 months | TNF-α, TNF Receptors 60 and 80, IL-1β, IL-6, IL-1, IL-2, ICAM-1, hsCRP, IL-10, sVCAM-1, insulin, leptin, and adiponectin | Baseline, 2 months, 4 months |
| Change from Baseline in Serum 25(OH)D concentrations at 2 months and 4 months | Baseline, 2 months, 4 months |
| Change from Baseline in Skin carotenoids at 2 months and 4 months | Baseline, 2 months, 4 months |
| Change from Baseline in Weight at 2 months and 4 months | Baseline, 2 months, 4 months |
| Change from Baseline in Red blood cell fatty acid profile at 2 months and 4 months | Baseline, 2 months, 4 months |
| Change from Baseline in Chemistry panel at 2 months and 4 months | Baseline, 2 months, 4 months |
| Change from Baseline in Thyroid panel at 2 months and 4 months | Baseline, 2 months, 4 months |
| Change from Baseline in Vital signs at 2 months and 4 months | Heart Rate and Blood Pressure | Baseline, 2 months, 4 months |
| Logan |
| Utah |
| 84322 |
| United States |
| Background |
| Earnest CP, Kupper JS, Thompson AM, Guo W, Church T. Complementary effects of multivitamin and omega-3 fatty acid supplementation on indices of cardiovascular health in individuals with elevated homocysteine. Int J Vitam Nutr Res. 2012 Feb;82(1):41-52. doi: 10.1024/0300-9831/a000093. |
| 19593941 | Background | Ebrahimi M, Ghayour-Mobarhan M, Rezaiean S, Hoseini M, Parizade SM, Farhoudi F, Hosseininezhad SJ, Tavallaei S, Vejdani A, Azimi-Nezhad M, Shakeri MT, Rad MA, Mobarra N, Kazemi-Bajestani SM, Ferns GA. Omega-3 fatty acid supplements improve the cardiovascular risk profile of subjects with metabolic syndrome, including markers of inflammation and auto-immunity. Acta Cardiol. 2009 Jun;64(3):321-7. doi: 10.2143/AC.64.3.2038016. |
| 17490962 | Background | Hill AM, Buckley JD, Murphy KJ, Howe PR. Combining fish-oil supplements with regular aerobic exercise improves body composition and cardiovascular disease risk factors. Am J Clin Nutr. 2007 May;85(5):1267-74. doi: 10.1093/ajcn/85.5.1267. |
| 15217806 | Background | Vanschoonbeek K, Feijge MA, Paquay M, Rosing J, Saris W, Kluft C, Giesen PL, de Maat MP, Heemskerk JW. Variable hypocoagulant effect of fish oil intake in humans: modulation of fibrinogen level and thrombin generation. Arterioscler Thromb Vasc Biol. 2004 Sep;24(9):1734-40. doi: 10.1161/01.ATV.0000137119.28893.0b. Epub 2004 Jun 24. |
| 17299483 | Background | Garg ML, Blake RJ, Clayton E, Munro IA, Macdonald-Wicks L, Singh H, Moughan PJ. Consumption of an n-3 polyunsaturated fatty acid-enriched dip modulates plasma lipid profile in subjects with diabetes type II. Eur J Clin Nutr. 2007 Nov;61(11):1312-7. doi: 10.1038/sj.ejcn.1602650. Epub 2007 Feb 7. |