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

Sponsor
Prof. Tony hayek MD (Other)
Overall Status
Unknown status
CT.gov ID
NCT03850314
Collaborator
(none)
50
Enrollment
1
Arm
15
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Glycine
 Phase 2/Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Effects of Glycine on Atherosclerosis and Metabolic Syndrome-related Parameters: A Clinical and Ex-vivo Study.
Anticipated Study Start Date :
Mar 1, 2019
Anticipated Primary Completion Date :
Dec 1, 2019
Anticipated Study Completion Date :
Jun 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Glycine

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
Glycine powder to be dissolved in water.

Outcome Measures

Primary Outcome Measures

  1. LDL Cholesterol levels [12 weeks]

    Change in LDL Cholesterol levels

Secondary Outcome Measures

  1. Triglyceride levels [12 weeks]

    Change in Triglyceride levels

  2. HDL Cholesterol levels [12 weeks]

    Change in HDL Cholesterol levels

  3. HbA1C levels [12 weeks]

    Change in Glycated hemoglobin (HbA1C) levels

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 65 Years
Sexes Eligible for Study:
Male
Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Prof. Tony hayek MD

Investigators

  • Principal Investigator: Tony Hayek, MD, Rambam Health Care Campus

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Prof. Tony hayek MD, Director, Department of Internal Medicine "E"., Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT03850314
Other Study ID Numbers:
  • RMB-18-0621
First Posted:
Feb 21, 2019
Last Update Posted:
Feb 21, 2019
Last Verified:
Feb 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Atherosclerosis
Metabolic Syndrome
Dyslipidemias
Syndrome
Glycine

Study Results

No Results Posted as of Feb 21, 2019