Nutritional Supplement Impact on Metabolic Parameters



Status:Active, not recruiting
Conditions:Endocrine
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:30 - 70
Updated:5/4/2016
Start Date:January 2015

Use our guide to learn which trials are right for you!

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.

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.

Inclusion Criteria:

1. Subject male or female between the ages of 30-70 at the time of informed consent.

2. 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

3. Hemoglobin A1C less than 6.5% at screening

4. BMI >27kg/m2

5. Blood Pressure <150/90 mm Hg

6. Subject is willing and able to comply with study restrictions, procedures, and
assessments.

7. Subject is able to swallow product without difficulty.

8. Subject is willing to fast for 8h prior to blood draw at screening, baseline, 2
month, and 4 month visits.

9. Subject is willing to maintain usual diet and physical activity for the duration of
the study.

10. Eats 1 or fewer servings of fatty fish per week (e.g. salmon, tuna, mackerel,
herring, anchovies, etc.)

11. 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.

12. 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:

1. Subject has a known allergy or intolerance to any of the ingredients contained in the
nutritional supplement.

2. Subject currently uses nicotine or has not quit using for at least 1 year.

3. Subject is taking an unapproved medication or has not been on a stable dose, for at
least 8 weeks, of approved medication.

4. Subject who has undergone any type of surgery on their intestines that would
interfere with product absorption, in the opinion of the investigator.

5. Subject is not willing to stop taking dietary/nutritional supplements for duration of
study.

6. Subject is taking any dietary/nutritional supplements, not provided by the sponsor,
within 30 days prior to investigational product administration.

7. Abnormalities in screening laboratory samples that the investigator would consider
unstable/unsafe.
We found this trial at
2
sites
Logan, Utah 84322
Principal Investigator: Michael Lefevre, PhD
Phone: 435-797-8262
?
mi
from
Logan, UT
Click here to add this to my saved trials
Austin, Texas 78731
Principal Investigator: Thomas Blevins, MD
Phone: 512-334-3505
?
mi
from
Austin, TX
Click here to add this to my saved trials