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

NCT02322294 | Completed Phase 2

• 1 other identifier: 14GGHF
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Protein; mung bean; glucose; triglycerides; insulin; body weight,; DXA scan

Outcome Measures

Primary Outcomes (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

  Baseline and week 8

Secondary Outcomes (10)

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

  Baseline and week 8

• Change in fasting glucose in subjects taking Glucodia™ versus Placebo

  Baseline, week 4 and week 8

• Change in fasting insulin in subjects taking Glucodia™ versus Placebo

  Baseline, week 4 and week 8

• Change in HOMA-IR in subjects taking Glucodia™ versus Placebo

  Baseline, week 4 and week 8

• Change in adiponectin levels in subjects taking Glucodia™ versus Placebo

  Baseline, week 4 and week 8

Other Outcomes (2)

• Changes in Vital Signs in subjects taking Glucodia™ versus Placebo

  Screening, Baseline, week 4, week 8

• Changes in Blood Hematology and Clinical Chemistry in subjects taking Glucodia™ versus Placebo

  Screening, Baseline, week 4 and week 8

Study Arms (2)

Glucodia™

EXPERIMENTAL

Dietary Supplement: Glucodia™

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Glucodia™ DIETARY_SUPPLEMENT

Glucodia™

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• KGK Science Inc.: lead
• Fuji Oil Co. Ltd.: collaborator

Study Sites (1)

KGK Synergize Inc.

London, Ontario, N6A 5R8, Canada

Location

MeSH Terms

Conditions

Body Weight; Insulin Resistance

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Tetyana Pelipyagina, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2014
• First Posted: December 23, 2014
• Study Start: January 1, 2015
• Primary Completion: March 1, 2016
• Last Updated: June 9, 2016

Record last verified: 2016-06

Locations

CA (1)