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Tracking Information | |
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First Received Date † | March 18, 2008 |
Last Updated Date | March 18, 2008 |
Start Date † | July 2006 |
Current Primary Outcome Measures † |
Weight loss [ Time Frame: Every 2 weeks ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures † | Same as current |
Change History | No Changes Posted |
Current Secondary Outcome Measures † |
Improve glucose metabolism [ Time Frame: Baseline and end of study ] [ Designated as safety issue: No ] |
Original Secondary Outcome Measures † | Same as current |
Descriptive Information | |
Brief Title † | Methionine-Restriction Diet (MRD) in Obese Adults With Metabolic Syndrome |
Official Title † | Methionine-Restriction Diet (MRD) in Obese Adults With Metabolic Syndrome |
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 adverse events and with an average weight loss of 8 kg. This study will test the ability of a low methionine diet to cause weight loss and improve the metabolic syndrome. The metabolic syndrome is driven by insulin resistance which is associated with abdominal fat, so this study hopes to reduce visceral fat, body weight and improve insulin resistance. Twenty-four healthy males or females 21 to 60 years of age, inclusive with a stable weight and a waist circumference >40" in men and >35" in women will participate in this study. Subjects will need at least two of the following: 1) HDL cholesterol < 40 mg/dL in men or < 50 mg/dl in women; 2) triglycerides > 150 mg/dL, 3) blood pressure >130/85 mmHg; 4) fasting glucose 110-125 mg/dL. Subjects who have diabetes, a history of heart attack, stroke, have had cancer in the last five years or take chronic medication for a significant illness will be excluded. Subjects will have a medical history, physical examination, chemistry panel, complete blood count (CBC), electrocardiogram, DEXA, abdominal CT scan to quantitate visceral fat, and blood will be sent to Orentreich for glucose, insulin, C-peptide, lipid profile with particle size, free fatty acids, adiponectin, leptin, high-sensitivity C-reactive protein, and insulin-like growth factor-1. Subjects will also undergo a hyperinsulinemic, euglycemic clamp to quantitate insulin resistance during an 18 hr inpatient stay, and will spend 24 hours in the metabolic chamber to measure metabolic rate. Subjects will then be placed on a diet of Hominex-2, a drink that will give them their protein in an amount based on their body weight, and they will see a dietitian who will give them a list of food they can eat consisting mainly of fruits, vegetables and a small amount of grains. Calories will not be restricted and subjects will receive a choline supplement of 500 mg/d. Subjects will be randomized to receive capsules containing methionine or placebo based on their body weight. The two groups will be on 2mg/kg/d or 23 mg/kg/d of methionine. Participants will return to PBRC every 2 weeks throughout the 16-week diet period to meet with the dietician, have weight and vital signs recorded, and have fasting blood drawn every 4 weeks to be sent to Orentreich for compliance measures. The physical exam, multi-slice CT scan, DEXA, inpatient admission for euglycemic hyperinsulinemic clamp, metabolic chamber stay, and the blood testing obtained at screening and baseline will be repeated at the completion of the 16 week diet period. There are no known risks to the low methionine diet, but some people may have gastrointestinal upsets when they change their diet. The risk of the CT scan is exposure to x-radiation equivalent to a front and side view chest x-ray. The risk of the DEXA is the exposure to x-irradiation equivalent to spending 12 hours in the sunshine. There are no risks to staying in the metabolic chamber. The hyperinsulinemic, euglycemic clamp could cause low blood sugar. This will be avoided by frequent monitoring of blood sugar, and if the low blood sugar were to occur, the test would be stopped and sugar given through the intravenous line. The testing of blood involves the discomfort of a needle going into an arm vein, bruising and rarely fainting or infection. These risks will be minimized by trained technicians using sterile needles. |
Study Phase | Phase II |
Study Type † | Interventional |
Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Condition † | Metabolic Syndrome |
Intervention † |
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Study Arms / Comparison Groups |
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Publications * | |
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |
Recruitment Status † | Active, not recruiting |
Enrollment † | 60 |
Estimated Completion Date | September 2008 |
Estimated Primary Completion Date | September 2008 (final data collection date for primary outcome measure) |
Eligibility Criteria † | Inclusion Criteria:
HDL cholesterol
Exclusion Criteria:
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Gender | Both |
Ages | 21 Years to 60 Years |
Accepts Healthy Volunteers | Yes |
Contacts †† | |
Location Countries † | United States |
Expanded Access Status | |
Administrative Information | |
NCT ID † | NCT00640757 |
Responsible Party | Thomas Gettys, Ph.D., Pennington Biomedical Research Center |
Secondary IDs †† | |
Study Sponsor † | Pennington Biomedical Research Center |
Collaborators †† | |
Investigators † | |
Information Provided By | Pennington Biomedical Research Center |
Verification Date | March 2008 |
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |