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Other Endocrine/Nutritional/Metabolic DisorderNCT02349555

Nutritional Supplement Impact on Metabolic Parameters

A study testing Nutritional Supplement Blend in people with Other Endocrine/Nutritional/Metabolic Disorder, run by Pharmanex at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 70 yearsHealthy volunteers can take part
What is being tested?
Nutritional Supplement Blend
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
2 sitesUnited States
Study dates
Jan 2015to Aug 2016
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 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Texas Diabetes & Endocrinology

    Austin, Texas, 78731

  • Utah State University

    Logan, Utah, 84322

Other trials in United States

About this study

Official title: An Open-Label Single-Center Study to Determine Safety and Effects of Novel Nutritional Blend on Inflammatory Balance Markers and Metabolic Parameters

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.

Read the detailed description

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.

Being tested
Nutritional Supplement Blend

What participants receive

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

  • Nutritional Supplement BlendDietary supplement

    It is to be taken orally at a dose of 4 capsules per day, 2 capsules with breakfast and 2 capsules with dinner.

Study groups in NCT02349555
Study groupRoleWhat they receive
Nutritional Supplement BlendExperimentalThe nutritional supplement contains a proprietary blend consisting of 15 unique nutritional ingredients.
Receives: Dietary Supplement: Nutritional Supplement Blend

What is being measured

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

  1. Change from Baseline in Serum Triglycerides at 2 months and 4 months

    Measured: Baseline, 2 months, 4 months

Secondary outcomes (17)

  1. Change from Baseline in Abdominal Obesity at 2 months and 4 months

    Measured: Baseline, 2 months, 4 months

  2. Change from Baseline in HDL cholesterol at 2 months and 4 months

    Measured: Baseline, 2 months, 4 months

  3. Change from Baseline in Fasting glucose at 2 months and 4 months

    Measured: Baseline, 2 months, 4 months

  4. Change from Baseline in Total cholesterol at 2 months and 4 months

    Measured: Baseline, 2 months, 4 months

  5. Change from Baseline in LDL density, particle size, and number at 2 months and 4 months

    Measured: Baseline, 2 months, 4 months

  6. Change from Baseline in Hemoglobin A1c at 2 months and 4 months

    Measured: Baseline, 2 months, 4 months

  7. Change from Baseline in Skin glycation (AGEs) at 2 months and 4 months

    Measured: Baseline, 2 months, 4 months

  8. Change from Baseline in Pulse wave velocity measurements at 2 months and 4 months

    Measured: Baseline, 2 months, 4 months

  9. Change from Baseline in Erythrocyte sedimentation rate at 2 months and 4 months

    Measured: Baseline, 2 months, 4 months

  10. 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

    Measured: Baseline, 2 months, 4 months

  11. Change from Baseline in Serum 25(OH)D concentrations at 2 months and 4 months

    Measured: Baseline, 2 months, 4 months

  12. Change from Baseline in Skin carotenoids at 2 months and 4 months

    Measured: Baseline, 2 months, 4 months

  13. Change from Baseline in Weight at 2 months and 4 months

    Measured: Baseline, 2 months, 4 months

  14. Change from Baseline in Red blood cell fatty acid profile at 2 months and 4 months

    Measured: Baseline, 2 months, 4 months

  15. Change from Baseline in Chemistry panel at 2 months and 4 months

    Measured: Baseline, 2 months, 4 months

  16. Change from Baseline in Thyroid panel at 2 months and 4 months

    Measured: Baseline, 2 months, 4 months

  17. Change from Baseline in Vital signs at 2 months and 4 months

    Heart Rate and Blood Pressure

    Measured: Baseline, 2 months, 4 months

Timeline

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

  1. First posted29 Jan 2015 (estimated)
  2. Study startJan 2015
  3. Primary completionAug 2016
  4. Study completionAug 2016

Resources

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
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02349555
Sponsor's protocol ID
14-PHX-0001
Status last verified
Sep 2016
First submitted
15 Jan 2015
Last updated
27 Sep 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 18757090

  • 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.

    PubMed 22811376

  • 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.

    PubMed 19593941

  • 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.

    PubMed 17490962

  • 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.

    PubMed 15217806

  • 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.

    PubMed 17299483

Questions about this trial

What is this clinical trial studying?

A study testing Nutritional Supplement Blend in people with Other Endocrine/Nutritional/Metabolic Disorder, run by Pharmanex at 2 sites 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 15 inclusion and 7 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 27 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. 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?

Change from Baseline in Serum Triglycerides at 2 months and 4 months (time frame: Baseline, 2 months, 4 months). 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 NCT02349555, which also lists 6 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 27 Sep 2016.

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