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

NCT04488653 | Unknown

• 1 other identifier: 19PMHD
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 hypothesized that HDL cholesterol will increase and systolic blood pressure will decrease therefore lowering CVD risk factors after supplementation with Oligopin®. Additionally, it is hypothesized that Oligopin® supplementation will reduce fasting glucose levels.

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Fasting blood sugar level

  Change in fasting blood sugar from baseline to day 84 between Oligopin® and placebo.

  84 days

Secondary Outcomes (35)

• Fasting insulin concentration

  Baseline, day 42 and day 84

• Fasting glucose level

  Baseline, day 42 and day 84

• Concentration of fasting low-density lipoprotein (LDL)

  Baseline, day 42 and day 84

• Change in fasting oxidized LDL (oxLDL).

  Baseline, day 42 and day 84

• Change in fasting high-density lipoprotein (HDL)

  Baseline, day 42 and day 84

Study Arms (2)

Oligopin®

EXPERIMENTAL

Oligopin® contains French Maritime Pine Bark Extract

Dietary Supplement: Oligopin®

Placebo

PLACEBO COMPARATOR

Placebo is a mixture of different inert compounds

Dietary Supplement: Placebo

Interventions

Oligopin® DIETARY_SUPPLEMENT

French Maritime Pine Bark Extract - 100mg/day

Oligopin®

Placebo DIETARY_SUPPLEMENT

Maltodextrin

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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%)

You may not qualify if:

• 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

Sponsors & Collaborators

• Les Derives Resiniques et Terpeniques: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc.

London, Ontario, N6A5R8, Canada

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Oligopin

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• David Crowley, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: July 28, 2020
• Study Start: June 24, 2020
• Primary Completion: October 19, 2021
• Study Completion: January 10, 2022
• Last Updated: August 26, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)