Status:

COMPLETED

Methionine-Restriction Diet (MRD) in Obese Adults With Metabolic Syndrome

Lead Sponsor:

Pennington Biomedical Research Center

Collaborating Sponsors:

Orentreich Foundation for the Advancement of Science, Inc.

Conditions:

Metabolic Syndrome

Eligibility:

All Genders

21-60 years

Phase:

PHASE2

Brief Summary

The purpose of this study is to determine if limiting dietary methionine (MET), one of the 10 essential amino acids (which make up proteins), causes weight loss and/or improves glucose metabolism.

Detailed Description

Methionine deficient diets have been shown to increase metabolic rate, decrease weight and extend lifespan in rodents. A methionine deficient diet has been tested for 17 weeks in humans without advers...

Eligibility Criteria

Inclusion

  • Male or female between the ages of 21 to 60, inclusive
  • Waist greater than 40 inches for men and 35 inches for women
  • Weight has been stable for at least 6 months (no more than 5 pounds gained or lost)
  • For women of childbearing potential: subject must be willing to use acceptable form of contraception (pill, condom, diaphragm etc.)
  • At least 2 of the following:
  • HDL cholesterol
  • Men \< 40 mg/dL
  • Women \< 50 mg/dL Triglycerides ≥150 mg/dL Blood pressure ≥130/≥ 85 mmHg Fasting glucose ≥110-125 mg/dL

Exclusion

  • Type 1 or Type 2 diabetes
  • History of heart attack or stroke
  • Pregnant or breastfeeding or planning to become pregnant during the study
  • Cancer (other than non-melanoma skin) within the last 5 years
  • Significant illness requiring medication
  • Inability to read and follow directions in English
  • Donated blood in the last 2 months.

Key Trial Info

Start Date :

July 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2008

Estimated Enrollment :

56 Patients enrolled

Trial Details

Trial ID

NCT00640757

Start Date

July 1 2006

End Date

December 1 2008

Last Update

December 18 2015

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