<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02192437</url>
  </required_header>
  <id_info>
    <org_study_id>03-13-2014</org_study_id>
    <nct_id>NCT02192437</nct_id>
  </id_info>
  <brief_title>Dietary Methionine and Cysteine Restriction in Healthy Adults</brief_title>
  <official_title>Dietary Methionine and Cysteine Restriction in Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Milton S. Hershey Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Orentreich Foundation for the Advancement of Science, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Milton S. Hershey Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Studies in laboratory models indicate that dietary methionine restriction (MR) enhances&#xD;
      longevity and produces short- and long-term metabolic changes that are consistent with a&#xD;
      healthy lifespan. The present study was designed to establish levels of dietary methionine or&#xD;
      methionine and cysteine that induce physiological changes in healthy adults like those&#xD;
      observed in rodent studies .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this controlled feeding study, subjects will be randomized to one of two experimental.&#xD;
      Group A (N=10): will start with control diet (31 mg/kg/day Met; 31 mg/kg/day Cys) for 4 weeks&#xD;
      followed by a washout for 3-4 weeks, then a 70% MR diet (9.3 mg/kg/day Met; 40.3 mg/kg/day&#xD;
      SAA) for 4 weeks, followed by 3-4 weeks washout period and then a 90% MR diet (3.1 mg/kg/day&#xD;
      Met; 34.1 mg/kg/day SAA) for 4 weeks. Group B (N=10): will start with control diet (31&#xD;
      mg/kg/day Met; 31 mg/kg/day Cys) for 4 weeks followed by a washout for 3-4 weeks then a 50%&#xD;
      methionine and cysteine restricted (M/CR) diet (15.5 mg/kg/day Met; 15.5 mg/kg/day Cys; 31&#xD;
      mg/kg/day SAA), followed by 3-4 weeks washout period and then a 65% M/CR diet (10.8 mg/kg/day&#xD;
      Met; 10.8 mg/kg/day Cys; 21.6 mg/kg/day SAA) for 4 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 16, 2014</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">July 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Body weight, plasma sulfur amino acids</measure>
    <time_frame>Baseline, four weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Biomarkers of oxidative stress, blood lipids</measure>
    <time_frame>Baseline, four weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Plasma IGF1, insulin</measure>
    <time_frame>Baseline, four weeks</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Methionine restricted diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention will be a Sulfur amino acid restricted diet (methionine). Control diet for 4 weeks followed by a washout for 3-4 weeks, then a methionine restricted diet (70%) for 4 weeks, followed by 3-4 weeks washout period and then a methionine restricted diet (90%) for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Methionine and cysteine restricted diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention will be a Sulfur amino acid restricted diet (methionine and cysteine). Control diet for 4 weeks followed by a washout for 3-4 weeks then a methionine and cysteine restricted diet (50%) followed by 3-4 weeks washout period and then a methionine and cysteine restricted diet (65%) for 4 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sulfur amino acid restricted diet</intervention_name>
    <description>Methionine restricted diet: 70% or 90% restriction Methionine and cysteine restricted diet: 50% or 65% restriction</description>
    <arm_group_label>Methionine and cysteine restricted diet</arm_group_label>
    <arm_group_label>Methionine restricted diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy English speaking male and female volunteers&#xD;
&#xD;
          -  May or may not be students&#xD;
&#xD;
          -  Age range 24-65 years&#xD;
&#xD;
          -  Subjects will need to be of normal weight or moderately overweight (BMI 18.5-35 kg/m2)&#xD;
&#xD;
          -  Subjects will be non-smokers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No use of medications known to impact the biomarkers of interest&#xD;
&#xD;
          -  Pregnancy and lactating women&#xD;
&#xD;
          -  Persons with documented diabetes&#xD;
&#xD;
          -  No use of high dose dietary antioxidant supplements or fish oil/flax seed oil for&#xD;
             n-acetylcysteine for at least 1 month prior to the study&#xD;
&#xD;
          -  Use of tobacco products over the past 6 months&#xD;
&#xD;
          -  Unstable weight&#xD;
&#xD;
          -  Individuals with allergies to eggs, wheat, nuts, soy and latex&#xD;
&#xD;
          -  Individuals with phenylketonuria (PKU)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>24 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John P Richie, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Penn State University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sailendra Nichenametla, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Orentreich Foundation for the Advancement of Science, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Penn State University</name>
      <address>
        <city>State College</city>
        <state>Pennsylvania</state>
        <zip>16802</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>September 4, 2020</last_update_submitted>
  <last_update_submitted_qc>September 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Milton S. Hershey Medical Center</investigator_affiliation>
    <investigator_full_name>John P. Richie</investigator_full_name>
    <investigator_title>Professor of Public Health Sciences &amp; Pharmacology</investigator_title>
  </responsible_party>
  <keyword>methionine</keyword>
  <keyword>cysteine</keyword>
  <keyword>sulfur amino acid restriction</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02192437
org study id: 03-13-2014
nct id: NCT02192437
lead sponsor: 
collaborator: 
has dmc: Yes
Studies in laboratory models indicate that dietary methionine restriction (MR) enhances
      longevity and produces short- and long-term metabolic changes that are consistent with a
      healthy lifespan. The present study was designed to establish levels of dietary methionine or
      methionine and cysteine that induce physiological changes in healthy adults like those
      observed in rodent studies .
In this controlled feeding study, subjects will be randomized to one of two experimental.
      Group A (N=10): will start with control diet (31 mg/kg/day Met; 31 mg/kg/day Cys) for 4 weeks
      followed by a washout for 3-4 weeks, then a 70% MR diet (9.3 mg/kg/day Met; 40.3 mg/kg/day
      SAA) for 4 weeks, followed by 3-4 weeks washout period and then a 90% MR diet (3.1 mg/kg/day
      Met; 34.1 mg/kg/day SAA) for 4 weeks. Group B (N=10): will start with control diet (31
      mg/kg/day Met; 31 mg/kg/day Cys) for 4 weeks followed by a washout for 3-4 weeks then a 50%
      methionine and cysteine restricted (M/CR) diet (15.5 mg/kg/day Met; 15.5 mg/kg/day Cys; 31
      mg/kg/day SAA), followed by 3-4 weeks washout period and then a 65% M/CR diet (10.8 mg/kg/day
      Met; 10.8 mg/kg/day Cys; 21.6 mg/kg/day SAA) for 4 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Body weight, plasma sulfur amino acids
time frame: Baseline, four weeks
measure: Biomarkers of oxidative stress, blood lipids
time frame: Baseline, four weeks
measure: Plasma IGF1, insulin
time frame: Baseline, four weeks
arm group label: Methionine restricted diet
arm group type: Experimental
description: Intervention will be a Sulfur amino acid restricted diet (methionine). Control diet for 4 weeks followed by a washout for 3-4 weeks, then a methionine restricted diet (70%) for 4 weeks, followed by 3-4 weeks washout period and then a methionine restricted diet (90%) for 4 weeks.
arm group label: Methionine and cysteine restricted diet
arm group type: Experimental
description: Intervention will be a Sulfur amino acid restricted diet (methionine and cysteine). Control diet for 4 weeks followed by a washout for 3-4 weeks then a methionine and cysteine restricted diet (50%) followed by 3-4 weeks washout period and then a methionine and cysteine restricted diet (65%) for 4 weeks.
intervention type: Other
intervention name: Sulfur amino acid restricted diet
description: Methionine restricted diet: 70% or 90% restriction Methionine and cysteine restricted diet: 50% or 65% restriction
arm group label: Methionine and cysteine restricted diet
arm group label: Methionine restricted diet
criteria: 
gender: All
minimum age: 24 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: John P Richie, PhD
role: Principal Investigator
affiliation: Penn State University
last name: Sailendra Nichenametla, Ph.D.
role: Principal Investigator
affiliation: Orentreich Foundation for the Advancement of Science, Inc.
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Milton S. Hershey Medical Center
investigator full name: John P. Richie
investigator title: Professor of Public Health Sciences & Pharmacology