A Study to Determine the Safety and Efficacy of Oligopin® on Metabolic Risk Factors in Subjects With Metabolic Syndrome

This is an interventional treatment trial for Metabolic Syndrome Read More

Inclusion Criteria:

• Provided voluntary, written, informed consent to participate in the study
• Males and females between 18 and 55 years of age, inclusive
• Female participant is not of child-bearing potential, defined as females who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, total endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or,

Females of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:

• Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-
• Provera, Lunelle), or hormone implant (Norplant System)
• Double-barrier method
• Intrauterine devices
• Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
• Vasectomy of partner at least 6 months prior to screening
• BMI between 25 to 34.9 kg/m2, inclusive
• Subjects with three or more of the following markers associated with metabolic syndrome:
• Abdominal obesity: waist circumference > 102 cm (40 inches) in men and > 88 cm (35 inches) in women
• Hypertension: systolic blood pressure > 130 mmHg or diastolic blood pressure > 85 mmHg
• Elevated fasting glucose > 5.6 mmol/L (> 100 mg/dL) and < 7.0 mmol/L (< 126 mg/dL) and/or elevated HbA1c (6.0-6.4%)
• Elevated TG: > 150 mg/dL (1.7 mmol/L)
• Low HDL-C: < 40 mg/dL (1.03 mmol/L) in men and < 50 mg/dL (1.29 mmol/L) in women
• Stable weight defined as < 5% change in body weight in six months prior to beginning of study
• Agrees to maintain current diet and exercise routine during the study
• Agrees to comply with all study-related procedures
• Otherwise healthy as determined by medical history, laboratory results, and physical exam as assessed by the Qualified Investigator (QI)

Exclusion Criteria:

• Women who are pregnant, breast feeding, or planning to become pregnant during the trial
• Blood donation 30 days prior to screening, during the study, or a planned donation within 30-days of the last study visit
• Participation in other clinical research trials 30 days prior to screening
• Individuals who are unable to give informed consent
• Current or history of any significant diseases of the gastrointestinal tract that may impact study outcomes as assessed by the QI
• Unstable metabolic disease or chronic diseases as assessed by the QI
• Unstable hypertension as assessed by the QI
• Type I or Type II diabetes
• Individuals with hypercholesterolemia and/or elevated triglycerides who are receiving medications to modulate lipid metabolism, as in Sections 6.3.1 and 6.3.2
• Individuals with an autoimmune disease or who are immune-compromised
• Self-reported HIV-, Hepatitis B- and/or C-positive diagnosis
• History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones symptom free for 6 months
• Self-reported current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
• Self-reported medical or neuropsychological condition and/or cognitive impairment that, in the QI's opinion, could interfere with study participation
• Self-reported blood/bleeding disorder
• Serious cardiovascular or respiratory disease as assessed by the QI.
• Major surgery in the past 3 months or individuals who have planned surgery during the course of the trial. Participants with minor surgery will be considered on a case-by-case basis by the QI
• Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
• Allergy, sensitivity, or intolerance to the investigational product's active or inactive ingredients, or the ingredients in the test meal
• Current use of prescribed medications listed in Section 6.3.1
• Current use of over-the-counter medications, supplements, foods and/or drinks listed in Section 6.3.2
• Medical use of cannabinoid products
• Chronic recreational use of cannabinoid products (>2 times/week). Occasional use will be assessed by the QI on a case-by-case basis
• Use of tobacco or nicotine-containing products within 60 days of screening
• Alcohol or drug abuse within the last 12 months
• High alcohol intake (average of >2 standard drinks per day
• Clinically significant abnormal laboratory results at screening as assessed by the QI
• Any other condition, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant