The study drug was not provided resulting in termination for unacceptable delays

The primary objective is to determine if subjects taking the natural product AphoelineBrake™ in addition to their standard treatment experience differences in metabolic disease control, gastrointestinal hormones and inflammatory markers diet, hunger, satiety, weight, compared to patients taking a placebo in addition to their standard treatment. The secondary objective is to study the effect of Aphoeline Brake on oxidative and inflammatory stress markers.

Inclusion Criteria:

• Age ≥21 years
• Diagnosis of T2DM
• Metformin as first line treatment
• HbA1c ≥7
• Calculated HOMA-IR ≥3.0,
• BMI 25-45
• Triglyceride level ≥ 2.26 mmol/L

Exclusion Criteria:

• Age <21 years of age
• BMI ≤ 25
• Pregnant
• Subjects on chronic nonsteroidal anti-inflammatory drugs or systemic corticosteroids.
• Subjects treated with Liraglutide (Victoza®).
• Renal, hepatic or cardiac failure.
• Subjects with a significant clinical illness within a month before the first administration of Aphoeline Brake™
• Subjects diagnosed with Irritable Bowel Syndrome.
• Subjects diagnosed with Ulcerative Colitis or Crohn's disease.
• History of significant gastrointestinal disease.
• Poor venous access.
• Poor likelihood to adhere with study procedures, as documented during the MyFitnessPal procedures prior to use of Aphoeline Brake™