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

NCT ID: NCT02322294

Last Updated: 2016-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31

Brief 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.

Conditions

Glucose Parameters; Triglycerides; Body Weight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: QUADRUPLE

Study Groups

Glucodia™

Group Type: EXPERIMENTAL

Glucodia™

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Interventions

Glucodia™

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.
• 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.

Exclusion Criteria

• 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)
• 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fuji Oil Co. Ltd.

UNKNOWN

Sponsor Role: collaborator

KGK Science Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tetyana Pelipyagina, MD

Role: PRINCIPAL_INVESTIGATOR

KGK Science Inc.

Locations

KGK Synergize Inc.

London, Ontario, Canada

Countries

Canada

Other Identifiers

14GGHF

Identifier Type: -

Identifier Source: org_study_id