Atherosclerosis, Diabetes Mellitus, Dyslipidemias, Metabolic Syndrome, Obesity
Conditions
Brief summary
The current study will test the central hypothesis that Glycine supplementation in humans improves Lipid profile and therefore reduces the risk of Atherosclerosis. Secondary outcomes including Insulin sensitivity and parameters related to Metabolic Syndrome (MetS) will also be measured. Furthermore, a mechanistic study in an ex-vivo model will test the hypothesis that Glycine via its key biosynthetic pathway involving Serine Hydroxymethyltransferase 2 (SHMT2), is athero-protective by inhibiting Sterol regulatory element-binding protein 2 (SREBP2)-mediated cholesterol biosynthesis in murine macrophage-like cell line.
Interventions
DIETARY_SUPPLEMENTGlycine
Glycine powder to be dissolved in water.
Sponsors
Prof. Tony hayek MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male between the ages of 40-65 years old. * Fulfill at least three of the five diagnostic criteria for the Metabolic Syndrome. * To be able to give their written consent to participate in this study.
Exclusion criteria
* Abnormal Liver function tests ≥ 3 times upper limit of normal (ULN). * Chronic liver disease other than NAFLD. * Previous gastric or small bowel surgery. * Abnormal Thyroid-stimulating hormone (TSH) level. * Known Tobacco Smoking more than 10 cigarettes per day. * Known alcohol consumption more than 2 drink per day. * Use of medications that include: Insulin or Insulin secretagogues, Thiazolidinediones, Glucocorticosteroids, Hormone replacement therapy. * Fever \> 38.2 °C in the past 2 weeks. * Autoimmune or Auto-inflammatory disease. * Chronic kidney disease ≥ stage III. * Nephrotic syndrome. * Hemoglobin \<12 g/dL. * Metal clips or implants that preclude magnetic resonance imaging.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LDL Cholesterol levels | 12 weeks | Change in LDL Cholesterol levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Triglyceride levels | 12 weeks | Change in Triglyceride levels |
| HDL Cholesterol levels | 12 weeks | Change in HDL Cholesterol levels |
| HbA1C levels | 12 weeks | Change in Glycated hemoglobin (HbA1C) levels |
Contacts
Primary ContactTony Hayek, MD
Outcome results
None listed