The Effects of Glycine on Atherosclerosis and Metabolic Syndrome-related Parameters.

Study Overview
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Brief Summary
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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.

Official Title
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The Effects of Glycine on Atherosclerosis and Metabolic Syndrome-related Parameters: A Clinical and Ex-vivo Study.

Conditions
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Metabolic Syndrome, Dyslipidemias, Diabetes Mellitus, Obesity, Atherosclerosis

Intervention / Treatment
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* Dietary Supplement: Glycine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glycine<br>Glycine total daily dose of 150mg/kg divided three times daily with meals (powder dissolved in 1 cup of water) for 12 weeks. | Dietary Supplement: Glycine<br>* Glycine powder to be dissolved in water.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL Cholesterol levels | Change in LDL Cholesterol levels | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglyceride levels | Change in Triglyceride levels | 12 weeks | 
| HDL Cholesterol levels | Change in HDL Cholesterol levels | 12 weeks | 
| HbA1C levels | Change in Glycated hemoglobin (HbA1C) levels | 12 weeks |