Effect of E Balance Pro Therapy on Diabetes and Related Complications

Inclusion criteria

• Male or female adults > 18 years of age.
• HbA1c 7.0% to 11.0% (inclusive).
• Body mass index 40.0kg/m2 or less.
• Non-smoker, or ex-smoker ≥3 months.
• Female participants of childbearing potential [i.e. not surgically sterilized or post-menopausal (greater than one year since last menses)] must have negative urine pregnancy test and must be using an effective birth control method, defined as:

• Continuous use of oral or long acting injected contraceptive for at least 2 months prior to study entry, or
• Use of an intra-uterine device or implantable contraceptive, or
• Use of double barrier methods of birth control, or
• Abstinence from heterosexual intercourse.
• Currently on lifestyle management and/or standard treatment for diabetes.
• Currently under the care of a physician.
• Able and willing to perform self-monitoring of plasma glucose regularly.
• Willing to avoid alcohol consumption for 24 h prior to every clinic visit.
• Willing to maintain a stable body weight, activity level, and dietary pattern, except for use of the study products, as directed.
• Willing and able to provide informed written consent prior to any study procedures.

Exclusion criteria

• Pregnancy or lactation, or participant unwilling to take appropriate contraceptives for the duration of the study
• History of significant cardiovascular or coronary heart disease (CVD or CHD) as defined by having had a coronary artery bypass procedure, coronary stent or angioplasty, or myocardial infarction in the past six (6) months.
• Current or recent (within six month of Visit 1) history of significant gastrointestinal, renal, pulmonary, hepatic or biliary disease, other endocrine diseases or invasive weight loss treatment.
• Subjects currently using pacemakers.
• History of epilepsy.
• Uncontrolled hypertension (blood pressure SBP > 180 and/or DBP ≥ 105 mm Hg) and unstable use (i.e. initiation or change in dose) of antihypertensive medications or thyroid hormone replacement medications within 3 months prior to Visit 1.
• Plasma creatinine above 130µmol/L or ALT more than twice (2x) upper limit of normal.
• Use of anticoagulants such as (not exhaustive):warfarin (Coumadin), dabigatran (Pradaxa), apixaban (Eliquis) or rivaroxaban (Xarelto). NOTE: Anti-platelet agents such as Plavix are allowed.
• Use of prescription non-steroidal anti-inflammatory drugs (or daily use of over the counter non-steroidal anti-inflammatory drugs >1month), steroids, corticosteroids, or any other prescription anti-inflammatory drugs within three (3) months prior to Visit 1.
• Use of any weight-loss programs or weight-loss medications (prescription or over- the counter) including, but not limited to, lipase inhibitors, within three (3) months prior to Visit 1.
• History of cancer (excluding non-melanoma skin cancer and basal cell carcinoma) in the past five (5) years.
• Presence or history (past 6 months) of alcohol or drug abuse; alcohol use of >2 standard alcoholic drinks per day (one drink= 12oz. beer, 4 oz. wine, 1.5 oz. hard liquor).
• Subject planning to undergo surgery during the study period or up to one (1) month after the study.
• Participant has a known allergy or intolerance to the test products or placebo.
• Participant is unwilling or unable to abide by the requirements of the protocol.
• Any condition that would interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study, or put the participant at risk
• Participant has taken an investigational health product or has participated in a research study within 30 days prior to first study visit.