Metabolic Effects of Betaine Supplementation
Condition: Obesity; Dysglycemia
MeSH terms: Obesity
Intervention: Betaine; Placebo
Intervention description: Betaine or placebo administered orally in divided doses over 12 weeks; Placebo administered orally in divided doses over 3 months
Intervention MeSH terms: Betaine; Glycine
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 28.0
Sex: All
Minimum age: 21 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Obesity; Glucose Intolerance

Summary:

      Betaine is important in cellular metabolic pathways. Few epidemiologic studies link betaine
      levels to diabetes and cardiovascular disease. Small human studies suggest benefit for
      non-alcoholic liver disease. In this study we will determine if administration of betaine
      improves metabolic measures, liver fat and/or endothelial function in humans with glucose
      intolerance who are overweight.
    

Eligibility criteria:

        Inclusion Criteria:

          -  1) Men and women aged 21-65 years old;

          -  2) Dysglycemia/prediabetes is defined as impaired fasting glucose (≥100 mg/dl),
             impaired glucose tolerance (2 hour post 75 g oral glucose load 140-200 mg/dl) or HbA1c
             5.7-6.5%);

          -  3) overweight to grade 3 obesity (BMI 25 to 45 kg/m2).

        Exclusion Criteria:

          -  1) cystathionine beta-synthase (CBS deficiency);

          -  2) Presence of liver disease other than NAFLD;

          -  3) Use of medications causing steatosis;

          -  4) Known alcohol consumption ≥ 2 drink per day;

          -  5) Use of medications known to cause insulin resistance;

          -  6) Use of weight loss drugs (or program) within 3 months of screening;

          -  7) Treatment with any experimental drug within the past 6 months;

          -  8) Subjects must be willing to abstain from use of phosphodiesterase type 5 (PDE-5)
             inhibitors;

          -  9) Pregnancy or lactation, and women of child bearing potential must use adequate
             contraception;

          -  10) Surgery within 30 days of screening;

          -  11) Heart disease defined as New York Heart Association Class III or IV cardiac status
             or hospitalization for congestive heart failure, unstable angina, myocardial
             infarction, cerebrovascular accident, transient ischemic attack or any
             revascularization within 6 months;

          -  12) Uncontrolled hypertension;

          -  13) eGFR <60; 14) History of acquired immune deficiency syndrome;

          -  15) History of malignancy within 5 years;

          -  16) Hemoglobin <12 g/dL (males), <10 g/dL (females);

          -  17) Triglycerides (TG) >500 mg/dL;

          -  18) Poor mental function or any other reason to expect patient difficulty in complying
             with study requirements;

          -  19) Metal clips or implants that preclude magnetic resonance imaging.