Nutritional Supplement Impact on Metabolic Parameters

NCT02349555 | Completed

• 1 other identifier: 14-PHX-0001
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Other Endocrine/Nutritional/Metabolic Disorder

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Serum Triglycerides at 2 months and 4 months

  Baseline, 2 months, 4 months

Secondary Outcomes (17)

• 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

• 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

Study Arms (1)

Nutritional Supplement Blend

EXPERIMENTAL

The nutritional supplement contains a proprietary blend consisting of 15 unique nutritional ingredients.

Dietary Supplement: Nutritional Supplement Blend

Interventions

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.

Nutritional Supplement Blend

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Abdominal obesity defined by \>102 cm (\>40in) waist circumference in men and \>88cm (\>35in) waist circumference in women, or
• Triglycerides ≥ 150mg/dL, or
• HDL cholesterol \<40 mg/dL in men and \<50 mg/dL in women
• 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.

You may not qualify if:

• Subject has a known allergy or intolerance to any of the ingredients contained in the nutritional supplement.
• Subject currently uses nicotine or has not quit using for at least 1 year.
• Subject is taking an unapproved medication or has not been on a stable dose, for at least 8 weeks, of approved medication.
• Subject who has undergone any type of surgery on their intestines that would interfere with product absorption, in the opinion of the investigator.
• Subject is not willing to stop taking dietary/nutritional supplements for duration of study.
• Subject is taking any dietary/nutritional supplements, not provided by the sponsor, within 30 days prior to investigational product administration.
• Abnormalities in screening laboratory samples that the investigator would consider unstable/unsafe.

Sponsors & Collaborators

• Pharmanex: lead
• Texas Diabetes & Endocrinology, P.A.: collaborator
• Utah State University: collaborator

Study Sites (2)

Texas Diabetes & Endocrinology

Austin, Texas, 78731, United States

Location

Utah State University

Logan, Utah, 84322, United States

Location

Related Publications (6)

• 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.

  PMID: 18757090 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.

  PMID: 22811376 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.

  PMID: 19593941 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.

  PMID: 17490962 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.

  PMID: 15217806 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.

  PMID: 17299483 BACKGROUND

Study Officials

• Thomas Blevins, MD

  Founder

  PRINCIPAL INVESTIGATOR

• Michael Lefevre, PhD

  Scientific Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2015
• First Posted: January 29, 2015
• Study Start: January 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 27, 2016

Record last verified: 2016-09

Locations

US (2)