Status:
UNKNOWN
A Study to Determine the Safety and Efficacy of Oligopin® on Metabolic Risk Factors in Subjects With Metabolic Syndrome
Lead Sponsor:
Les Derives Resiniques et Terpeniques
Collaborating Sponsors:
KGK Science Inc.
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
The safety and efficacy of Oligopin® will be compared against a placebo to evaluate the effect on metabolic risk factors in subjects with metabolic syndrome. During the 84-day study period it is hypot...
Detailed Description
Metabolic syndrome (MetS) is a combination of risk factors for chronic conditions such as cardiovascular disease (CVD) and type 2 diabetes (T2D). These risk factors include obesity (particularly abdom...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 10 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04488653
Start Date
June 24 2020
End Date
January 10 2022
Last Update
August 26 2021
Active Locations (1)
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1
KGK Science Inc.
London, Ontario, Canada, N6A5R8