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

NCT00640757 | Completed Phase 2

• 1 other identifier: PBRC 26009
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metabolic Syndrome

Keywords

Methionine; Metabolic syndrome; Glucose Metabolism; Amino acid; Insulin clamp

Outcome Measures

Primary Outcomes (1)

• Weight loss

  Every 2 weeks

Secondary Outcomes (1)

• Improve glucose metabolism

  Baseline and end of study

Study Arms (2)

Low Methionine 1

ACTIVE COMPARATOR

Methionine deficient diet

Dietary Supplement: Methionine deficient diet

Placebo 2

PLACEBO COMPARATOR

Placebo comparator methionine complete diet

Dietary Supplement: Methionine sufficient diet

Interventions

Methionine deficient diet DIETARY_SUPPLEMENT

Hominex with a low protein diet

Also known as: Hominex, Methionine

Low Methionine 1

Methionine sufficient diet DIETARY_SUPPLEMENT

Hominex, low protein diet and methionine capsules

Also known as: Hominex, Methionine capsules, Low protein diet

Placebo 2

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• Orentreich Foundation for the Advancement of Science, Inc.: collaborator

Related Publications (1)

• Plaisance EP, Greenway FL, Boudreau A, Hill KL, Johnson WD, Krajcik RA, Perrone CE, Orentreich N, Cefalu WT, Gettys TW. Dietary methionine restriction increases fat oxidation in obese adults with metabolic syndrome. J Clin Endocrinol Metab. 2011 May;96(5):E836-40. doi: 10.1210/jc.2010-2493. Epub 2011 Feb 23.

  PMID: 21346062 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Methionine; Diet, Protein-Restricted

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids, Essential; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Neutral; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Thomas W Gettys, Ph.D.

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 18, 2008
• First Posted: March 21, 2008
• Study Start: July 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: December 18, 2015

Record last verified: 2015-12