Nutritional Supplement Impact on Metabolic Parameters

Completed · Not applicable

Conditions studied: Other Endocrine/Nutritional/Metabolic Disorder

In brief

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.

Key facts

Study ID

NCT02349555

Run by

Pharmanex

People needed

41

Starts

2015-01-01

Expected to finish

2016-08-01

Last updated by the study team

2016-09-27

Who can join

Age: 30 and older, up to 70. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Texas Diabetes & Endocrinology — Austin, Texas, United States
• Utah State University — Logan, Utah, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.