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Glucose ParametersPhase 214GGHFNCT02322294

Investigating the Effects of Glucodia™ on Glucose Parameters, Triglycerides and Body Weight

A Phase 2 study testing Glucodia™ in people with Glucose Parameters and Triglycerides, run by KGK Science Inc. at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is investigating the effects of 8 weeks of supplementation with Glucodia™, on glucose parameters, triglycerides and body weight as compared to a placebo. Half of the subjects will be administered Glucodia™, while the other half will receive placebo. Read more about this study

Who is it for?
Ages 21 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Glucose Parameters, Triglycerides, Body Weight
What is being tested?
Glucodia™
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteCanada
Study dates
Jan 2015to Mar 2016
Phase
Phase 2
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 21 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy male or female adults, aged 21 to 45 years
  • BMI of 25 kg/m2 to 40 kg/m2 (inclusive)
  • Subjects with Fasting Plasma Glucose 5.56mmol/L to 6.94mmol/L (100mg/dL-125mg/dL) AND EITHER Fasting Insulin 60 pmol/L to 180 pmol/L OR Triglycerides 1.36mmol/L to 3.39 mmol/L (120mg/dL-300mg/dL)
  • Subject is not of child bearing potential. Defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation).
  • OR Female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. 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 (condoms with spermicide or diaphragm with spermacide), Non-hormonal intrauterine devices, Vasectomy of partner, Non-heterosexual lifestyle
  • Subjects who have no plans to change their smoking habits during the trial period.
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  • Subjects who are normally active and are deemed to be healthy by the Medical Director
  • Subjects who agree to maintain their current level of activity throughout the trial period.
  • Subjects who agree to maintain their current dietary habits throughout the trial period.
  • Subjects who have given voluntary, written, informed consent to participate in the study.

Who cannot join

  • Subjects who are pregnant, breastfeeding or planning on becoming pregnant throughout the course of the study.
  • Subjects with Fasting Glucose < 5.56 mmol/L or > 6.94 mmol/L
  • Subjects with Fasting Plasma Glucose 5.56 mmol/L to 6.94 mmol/L who DO NOT have EITHER Fasting Insulin 60 pmol/L to 180 pmol/L OR Triglycerides 1.35 mmol/L to 3.39 mmol/L
  • Subjects with BMI < 25 kg/m2 or > 40 kg/m2
  • Subjects who have experienced weight loss or gain of greater than 4.5 kg (approximately 10 lbs) in the past 3 months
  • Subjects with uncontrolled hypertension ( ≥ 140 mmHg)
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  • Subjects with any major diseases of the cardiovascular, renal, hepatic, gastrointestinal, pulmonary or endocrine systems
  • History of or current diagnosis of any cancer (except for successfully treated basal cell carcinoma) diagnosed less than 5 years prior to screening. Subjects with cancer in full remission more than 5 years after diagnosis are acceptable
  • Subjects with neurological disorders or significant psychiatric illnesses
  • Subjects with unstable thyroid disease
  • Subjects who are immuno-compromised (HIV positive, on anti-rejection medication, rheumatoid arthritis)
  • Subjects who have taken any medication or natural health products intended for the management of diabetes, dyslipidemia or body weight within 3 months of randomization.
  • Subjects who use illicit drugs or have a history of alcohol or drug abuse within the past 6 months
  • Subjects who currently consume greater than 2 standard alcoholic drinks per day.
  • Subjects who have participated in a clinical research trial within 30 days prior to randomization.
  • Subjects with an allergy or sensitivity to the investigational product ingredient.
  • Subjects who are cognitively impaired and/or who are unable to give informed consent
  • Subjects who have abnormal laboratory results or any other medical or psychological condition which, in the opinion of the Principle Investigator, may adversely affect the subjects ability to complete the study or its measures or which may pose significant risk to the subject

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • KGK Synergize Inc.

    London, Ontario, N6A 5R8

Other trials in Canada

About this study

Official title: A Double-Blind, Placebo-Controlled, Parallel Study to Investigate the Effects of 8 Weeks Use of Glucodia™ on Glucose Parameters, Triglycerides and Body Weight as Compared to Placebo

This study is investigating the effects of 8 weeks of supplementation with Glucodia™, on glucose parameters, triglycerides and body weight as compared to a placebo. Half of the subjects will be administered Glucodia™, while the other half will receive placebo.

Being tested
Glucodia™, Placebo
Keywords
Protein, mung bean, glucose, triglycerides, insulin, body weight,, DXA scan
Medical subject headings
Body Weight, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Glucodia™Dietary supplement

  • PlaceboOther

Study groups in NCT02322294
Study groupRoleWhat they receive
Glucodia™ExperimentalNot described
Receives: Dietary Supplement: Glucodia™
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in glucose response to 2-hour oral glucose tolerance test (OGTT) in subjects taking Glucodia™ versus Placebo

    Assessed by the change in the area under the curve in glucose response

    Measured: Baseline and week 8

Secondary outcomes (10)

  1. Change in insulin response to 2-hour oral glucose tolerance test (OGTT) in subjects taking Glucodia™ versus Placebo

    Assessed by the change in the area under the curve in insulin response

    Measured: Baseline and week 8

  2. Change in fasting glucose in subjects taking Glucodia™ versus Placebo

    Measured: Baseline, week 4 and week 8

  3. Change in fasting insulin in subjects taking Glucodia™ versus Placebo

    Measured: Baseline, week 4 and week 8

  4. Change in HOMA-IR in subjects taking Glucodia™ versus Placebo

    Measured: Baseline, week 4 and week 8

  5. Change in adiponectin levels in subjects taking Glucodia™ versus Placebo

    Measured: Baseline, week 4 and week 8

  6. Change in lipid panel levels in subjects taking Glucodia™ versus Placebo

    Lipid panel includes total cholesterol, triglycerides, HDL, LDL, free fatty acids and non-esterified fatty acids

    Measured: Baseline, week 4 and week 8

  7. Change in body composition in subjects taking Glucodia™ versus Placebo

    Assessed via DXA scan

    Measured: Baseline, week 4 and week 8

  8. Change in body composition in subjects taking Glucodia™ versus Placebo

    Assessed via circumference measurements of the arm, thigh, hip and waist and the hip to waist ratio

    Measured: Baseline, week 4 and week 8

  9. Change in body weight in subjects taking Glucodia™ versus Placebo

    Measured: Baseline, week 4 and week 8

  10. Change in appetite in subjects taking Glucodia™ versus Placebo

    Assessed using a Satiety VAS scale questionnaire

    Measured: Baseline, week 4 and week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2014 (estimated)
  2. Study startJan 2015
  3. Primary completionMar 2016

Resources

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 2
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02322294
Sponsor's protocol ID
14GGHF
Acronym
14GGHF
Status last verified
Jun 2016
First submitted
17 Dec 2014
Last updated
9 Jun 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Glucodia™ in people with Glucose Parameters and Triglycerides, run by KGK Science Inc. 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 10 inclusion and 18 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: finished, as of the sponsor's last update on 9 Jun 2016. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in glucose response to 2-hour oral glucose tolerance test (OGTT) in subjects taking Glucodia™ versus Placebo (time frame: Baseline and week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02322294.

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 9 Jun 2016.

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