Metabolic SyndromeNCT04488653
A Study to Determine the Safety and Efficacy of Oligopin® on Metabolic Risk Factors in Subjects With Metabolic Syndrome
A study testing Oligopin® in people with Metabolic Syndrome, run by Les Derives Resiniques et Terpeniques at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Oligopin®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 24 Jun 2020to 10 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Show all 21Show fewer
- 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)
Who cannot join
- 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
Show all 28Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Study to Determine the Safety and Efficacy of Oligopin® on Metabolic Risk Factors in Subjects With Metabolic Syndrome
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.
Read the 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 abdominal obesity), high blood pressure, elevated triglycerides, low high-density lipoprotein (HDL) cholesterol, and elevated fasting blood glucose. MetS reflects overnutrition and sedentary lifestyles as the prevalence of MetS increases concomitantly with these lifestyle choices. Most recent estimates suggest that approximately 19.1% of the Canadian population, 34.2% of the US population, and 24.3% of the European population have MetS. Significantly, the prevalence of MetS in adults aged 18-39 has increased dramatically over the last 2 decades.
MetS commonly precedes the development of CVD and is associated with a 2-fold increase in the risk of CVD mortality. MetS also increases the risk of developing T2D and is suggested to be extremely prevalent (90-95%) in Caucasian individuals diagnosed with T2D. Indeed, the presence of even one MetS risk factor early in life increases the chances of developing a chronic disease later in life. Currently, MetS risk factors are estimated to be present in 4.8-7% of individuals from 18 to 30 years of age. Therefore, preventing the development of or treating these risk factors earlier in life could reduce the development of chronic disease.
The pathogenic mechanisms of MetS remain to be fully elucidated, however insulin resistance (IR) appears to play a pivotal role in the initiation and progression of the syndrome. Abdominal obesity is a well-known contributor to IR. Abdominal fat accumulation increases the supply of free fatty acids (FFAs) to the liver and indirectly results in an increase in plasma low-density lipoprotein (LDL) cholesterol and a decrease in HDL cholesterol. IR also elevates fasting blood glucose levels due to the suppression of hepatic glycogen synthesis and impairs postprandial glucose control by reducing insulin stimulated glucose uptake by peripheral tissues.
There is a need for natural interventions that aid in the prevention and treatment of MetS risk factors as the prevalence of overnutrition and sedentary lifestyles continues to increase. This study will assess the ability of Oligopin® to improve abdominal obesity, fasting blood glucose, postprandial glucose and insulin response, and HDL-cholesterol levels as these outcomes reliably predict an individual's MetS risk. Oligopin® is a French Maritime Pine Bark Extract (FMPBE) obtained from the pine tree Pinus pinaster. It is rich in low molecular weight oligomeric procyanidins (OPC) with 20% of OPCs in the form of dimers as compared to the most studied FMPBE Pycogenol®, which contains only 5% of OPCs as dimers.
Recently, Oligopin® supplementation was shown to reduce CVD risk factors. In a randomized, double-blind, placebo-controlled clinical trial, Oligopin® consumption increased HDL cholesterol levels and reduced systolic blood pressure and oxidized LDL (oxLDL) levels in stage 1 hypertensive individuals. This is significant as low HDL was reported to be the most prevalent risk factor for the development of MetS in young adults. FMPBE supplementation has also been shown to reduce fasting glucose levels in individuals with T2D. Interestingly, FMPBE is a potent inhibitor of α-glucosidase, which catalyses the breakdown of oligosaccharides in the small intestine to permit glucose resorption. Therefore, it is possible that Oligopin® may reduce fasting glucose levels and control postprandial hyperglycemia. This randomized, double-blind, placebo-controlled study will determine the efficacy of Oligopin® to improve markers of metabolic risk in subjects with MetS.
- Conditions
- Metabolic Syndrome
- Being tested
- Oligopin®, Placebo
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oligopin®Dietary supplement
French Maritime Pine Bark Extract - 100mg/day
PlaceboDietary supplement
Maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Oligopin® | Experimental | Oligopin® contains French Maritime Pine Bark Extract Receives: Dietary Supplement: Oligopin® |
| Placebo | Placebo comparator | Placebo is a mixture of different inert compounds Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting blood sugar level
Change in fasting blood sugar from baseline to day 84 between Oligopin® and placebo.
Measured: 84 days
Secondary outcomes (35)
Fasting insulin concentration
Change in fasting insulin between Oligopin® and placebo from baseline to day 42, baseline to day 84, and from day 42 to day 84
Measured: Baseline, day 42 and day 84
Fasting glucose level
Change in fasting glucose between Oligopin® and placebo baseline to day 42, baseline to day 84, and from day 42 to day 84
Measured: Baseline, day 42 and day 84
Concentration of fasting low-density lipoprotein (LDL)
Change in fasting LDL between Oligopin® and placebo from baseline to day 42, baseline to day 84, and from day 42 to day 84
Measured: Baseline, day 42 and day 84
Change in fasting oxidized LDL (oxLDL).
Change in fasting oxLDL between Oligopin® and placebo from baseline to day 42, baseline to day 84, and from day 42 to day 84
Measured: Baseline, day 42 and day 84
Change in fasting high-density lipoprotein (HDL)
Change in fasting HDL between Oligopin® and placebo from baseline to day 42, baseline to day 84, and from day 42 to day 84
Measured: Baseline, day 42 and day 84
Change in fasting total cholesterol
Change in fasting total cholesterol between Oligopin® and placebo baseline to day 42, baseline to day 84, and from day 42 to day 84
Measured: Baseline, day 42 and day 84
Postprandial glucose at 20, 30, 90, or 120 min after meal
Change in postprandial glucose between Oligopin® and placebo from baseline to day 42, baseline to day 84, and from day 42 to day 84
Measured: Baseline, day 42 and day 84
Postprandial insulin at 20, 30, 90, or 120 min after meal
Change in postprandial glucose between Oligopin® and placebo from baseline to day 42, baseline to day 84, and from day 42 to day 84
Measured: Baseline, day 42 and day 84
BMI
Change in BMI between Oligopin® and placebo from baseline to day 42, baseline to day 84, and from day 42 to day 84
Measured: Baseline, day 42 and day 84
Waist circumference
Change in waist circumference between Oligopin® and placebo from baseline to day 42, baseline to day 84, and from day 42 to day 84
Measured: Baseline, day 42 and day 84
Blood pressure
Change in systolic and diastolic blood pressure between Oligopin® and placebo from baseline to day 42, baseline to day 84, and from day 42 to day 84
Measured: Baseline, day 42 and day 84
Heart rate
Change in heart rate between Oligopin® and placebo from baseline to day 42, baseline to day 84, and from day 42 to day 84
Measured: 84 days
Alanine aminotransferase (ALT)
Change in ALT between Oligopin® and placebo pre-baseline and day 84.
Measured: Pre-baseline and 84 days
Aspartate transaminase (AST)
Change in AST between Oligopin® and placebo pre-baseline and day 84.
Measured: Pre-baseline and 84 days
Total bilirubin
Change in total bilirubin between Oligopin® and placebo pre-baseline and day 84.
Measured: Pre-baseline and 84 days
Creatinine
Change in creatinine between Oligopin® and placebo pre-baseline and day 84.
Measured: Pre-baseline and 84 days
Sodium ion
Change in sodium ion between Oligopin® and placebo pre-baseline and day 84.
Measured: Pre-baseline and 84 days
Potassium ion
Change in potassium ion between Oligopin® and placebo pre-baseline and day 84.
Measured: Pre-baseline and 84 days
Chloride ion
Change in chloride ion between Oligopin® and placebo pre-baseline and day 84.
Measured: Pre-baseline and 84 days
estimated glomerular filtration rate (eGFR)
Change in eGFR between Oligopin® and placebo pre-baseline and day 84.
Measured: Pre-baseline and 84 days
White blood cell (WBC) count
Change in WBC count between Oligopin® and placebo pre-baseline and day 84.
Measured: Pre-baseline and 84 days
Neutrophils
Change in neutrophil count between Oligopin® and placebo pre-baseline and day 84.
Measured: Pre-baseline and 84 days
Lymphocytes
Change in lymphocyte count between Oligopin® and placebo pre-baseline and day 84.
Measured: Pre-baseline and 84 days
Monocytes
Change in monocyte count between Oligopin® and placebo pre-baseline and day 84.
Measured: Pre-baseline and 84 days
Eosinophils
Change in eosinophil count between Oligopin® and placebo pre-baseline and day 84.
Measured: Pre-baseline and 84 days
Basophils
Change in basophil count between Oligopin® and placebo pre-baseline and day 84.
Measured: Pre-baseline and 84 days
Red blood cell (RBC)
Change in RBC count between Oligopin® and placebo pre-baseline and day 84.
Measured: Pre-baseline and 84 days
Hemoglobin
Change in hemoglobin level between Oligopin® and placebo pre-baseline and day 84.
Measured: Pre-baseline and 84 days
Hematocrit
Change in hematocrit level between Oligopin® and placebo pre-baseline and day 84.
Measured: Pre-baseline and 84 days
Platelet
Change in platelet count between Oligopin® and placebo pre-baseline and day 84.
Measured: Pre-baseline and 84 days
Mean corpuscular volume (MCV)
Change in MCV level between Oligopin® and placebo pre-baseline and day 84.
Measured: Pre-baseline and 84 days
Mean corpuscular hemoglobin (MCH)
Change in MCH level between Oligopin® and placebo pre-baseline and day 84.
Measured: Pre-baseline and 84 days
Mean corpuscular hemoglobin concentration (MCHC)
Change in MCHC level between Oligopin® and placebo pre-baseline and day 84.
Measured: Pre-baseline and 84 days
Mean platelet volume (MPV)
Change in MPV level between Oligopin® and placebo pre-baseline and day 84.
Measured: Pre-baseline and 84 days
Red cell distribution width (RDW)
Change in RDW level between Oligopin® and placebo pre-baseline and day 84.
Measured: Pre-baseline and 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start24 Jun 2020
- Primary completion19 Oct 2021 (estimated)
- Study completion10 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Les Derives Resiniques et Terpeniques
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- David Crowley, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488653
- Sponsor's protocol ID
- 19PMHD
- Status last verified
- Aug 2021
- First submitted
- 23 Jul 2020
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel Study to Determine the Safety and Efficacy of Oligopin® on Metabolic Risk Factors in Subjects With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT04488653
- Acronym / sponsor ID
- 19PMHD
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Les Derives Resiniques et TerpeniquesIndustry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- 24 Jun 2020 (actual)
- Primary completion
- 19 Oct 2021 (estimated)
- Study completion
- 10 Jan 2022 (estimated)
- First posted
- 28 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 abdominal obesity), high blood pressure, elevated triglycerides, low high-density lipoprotein (HDL) cholesterol, and elevated fasting blood glucose. MetS reflects overnutrition and sedentary lifestyles as the prevalence of MetS increases concomitantly with these lifestyle choices. Most recent estimates suggest that approximately 19.1% of the Canadian population, 34.2% of the US population, and 24.3% of the European population have MetS. Significantly, the prevalence of MetS in adults aged 18-39 has increased dramatically over the last 2 decades.
MetS commonly precedes the development of CVD and is associated with a 2-fold increase in the risk of CVD mortality. MetS also increases the risk of developing T2D and is suggested to be extremely prevalent (90-95%) in Caucasian individuals diagnosed with T2D. Indeed, the presence of even one MetS risk factor early in life increases the chances of developing a chronic disease later in life. Currently, MetS risk factors are estimated to be present in 4.8-7% of individuals from 18 to 30 years of age. Therefore, preventing the development of or treating these risk factors earlier in life could reduce the development of chronic disease.
The pathogenic mechanisms of MetS remain to be fully elucidated, however insulin resistance (IR) appears to play a pivotal role in the initiation and progression of the syndrome. Abdominal obesity is a well-known contributor to IR. Abdominal fat accumulation increases the supply of free fatty acids (FFAs) to the liver and indirectly results in an increase in plasma low-density lipoprotein (LDL) cholesterol and a decrease in HDL cholesterol. IR also elevates fasting blood glucose levels due to the suppression of hepatic glycogen synthesis and impairs postprandial glucose control by reducing insulin stimulated glucose uptake by peripheral tissues.
There is a need for natural interventions that aid in the prevention and treatment of MetS risk factors as the prevalence of overnutrition and sedentary lifestyles continues to increase. This study will assess the ability of Oligopin® to improve abdominal obesity, fasting blood glucose, postprandial glucose and insulin response, and HDL-cholesterol levels as these outcomes reliably predict an individual's MetS risk. Oligopin® is a French Maritime Pine Bark Extract (FMPBE) obtained from the pine tree Pinus pinaster. It is rich in low molecular weight oligomeric procyanidins (OPC) with 20% of OPCs in the form of dimers as compared to the most studied FMPBE Pycogenol®, which contains only 5% of OPCs as dimers.
Recently, Oligopin® supplementation was shown to reduce CVD risk factors. In a randomized, double-blind, placebo-controlled clinical trial, Oligopin® consumption increased HDL cholesterol levels and reduced systolic blood pressure and oxidized LDL (oxLDL) levels in stage 1 hypertensive individuals. This is significant as low HDL was reported to be the most prevalent risk factor for the development of MetS in young adults. FMPBE supplementation has also been shown to reduce fasting glucose levels in individuals with T2D. Interestingly, FMPBE is a potent inhibitor of α-glucosidase, which catalyses the breakdown of oligosaccharides in the small intestine to permit glucose resorption. Therefore, it is possible that Oligopin® may reduce fasting glucose levels and control postprandial hyperglycemia. This randomized, double-blind, placebo-controlled study will determine the efficacy of Oligopin® to improve markers of metabolic risk in subjects with MetS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oligopin® | Experimental | Dietary Supplement: Oligopin®Oligopin® contains French Maritime Pine Bark Extract |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo is a mixture of different inert compounds |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- 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-
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oligopin®French Maritime Pine Bark Extract - 100mg/day | Dietary supplement | Oligopin® |
| PlaceboMaltodextrin | Dietary supplement | Placebo |
Primary outcome
Fasting blood sugar level
Time frame: 84 days
Change in fasting blood sugar from baseline to day 84 between Oligopin® and placebo.
35 secondary outcomes
Fasting insulin concentration
Time frame: Baseline, day 42 and day 84
Fasting glucose level
Time frame: Baseline, day 42 and day 84
Concentration of fasting low-density lipoprotein (LDL)
Time frame: Baseline, day 42 and day 84
Change in fasting oxidized LDL (oxLDL).
Time frame: Baseline, day 42 and day 84
Change in fasting high-density lipoprotein (HDL)
Time frame: Baseline, day 42 and day 84
Change in fasting total cholesterol
Time frame: Baseline, day 42 and day 84
Postprandial glucose at 20, 30, 90, or 120 min after meal
Time frame: Baseline, day 42 and day 84
Postprandial insulin at 20, 30, 90, or 120 min after meal
Time frame: Baseline, day 42 and day 84
BMI
Time frame: Baseline, day 42 and day 84
Waist circumference
Time frame: Baseline, day 42 and day 84
Blood pressure
Time frame: Baseline, day 42 and day 84
Heart rate
Time frame: 84 days
Alanine aminotransferase (ALT)
Time frame: Pre-baseline and 84 days
Aspartate transaminase (AST)
Time frame: Pre-baseline and 84 days
Total bilirubin
Time frame: Pre-baseline and 84 days
Creatinine
Time frame: Pre-baseline and 84 days
Sodium ion
Time frame: Pre-baseline and 84 days
Potassium ion
Time frame: Pre-baseline and 84 days
Chloride ion
Time frame: Pre-baseline and 84 days
estimated glomerular filtration rate (eGFR)
Time frame: Pre-baseline and 84 days
White blood cell (WBC) count
Time frame: Pre-baseline and 84 days
Neutrophils
Time frame: Pre-baseline and 84 days
Lymphocytes
Time frame: Pre-baseline and 84 days
Monocytes
Time frame: Pre-baseline and 84 days
Eosinophils
Time frame: Pre-baseline and 84 days
Basophils
Time frame: Pre-baseline and 84 days
Red blood cell (RBC)
Time frame: Pre-baseline and 84 days
Hemoglobin
Time frame: Pre-baseline and 84 days
Hematocrit
Time frame: Pre-baseline and 84 days
Platelet
Time frame: Pre-baseline and 84 days
Mean corpuscular volume (MCV)
Time frame: Pre-baseline and 84 days
Mean corpuscular hemoglobin (MCH)
Time frame: Pre-baseline and 84 days
Mean corpuscular hemoglobin concentration (MCHC)
Time frame: Pre-baseline and 84 days
Mean platelet volume (MPV)
Time frame: Pre-baseline and 84 days
Red cell distribution width (RDW)
Time frame: Pre-baseline and 84 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Crowley, MD principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oligopin® in people with Metabolic Syndrome, run by Les Derives Resiniques et Terpeniques at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting blood sugar level (time frame: 84 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2021.