Nutritional Supplement Impact on Metabolic Parameters

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Other Endocrine/Nutritional/Metabolic Disorder

Intervention / Treatment
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* Dietary Supplement: Nutritional Supplement Blend


Participation Criteria
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Eligibility Criteria
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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: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutritional Supplement Blend<br>The nutritional supplement contains a proprietary blend consisting of 15 unique nutritional ingredients. | Dietary Supplement: Nutritional Supplement Blend<br>* It is to be taken orally at a dose of 4 capsules per day, 2 capsules with breakfast and 2 capsules with dinner.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Serum Triglycerides at 2 months and 4 months |  | Baseline, 2 months, 4 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |