- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02192437
Dietary Methionine and Cysteine Restriction in Healthy Adults
September 4, 2020 updated by: John P. Richie, Milton S. Hershey Medical Center
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 .
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
State College, Pennsylvania, United States, 16802
- Penn State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
24 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy English speaking male and female volunteers
- May or may not be students
- Age range 24-65 years
- Subjects will need to be of normal weight or moderately overweight (BMI 18.5-35 kg/m2)
- Subjects will be non-smokers
Exclusion Criteria:
- No use of medications known to impact the biomarkers of interest
- Pregnancy and lactating women
- Persons with documented diabetes
- No use of high dose dietary antioxidant supplements or fish oil/flax seed oil for n-acetylcysteine for at least 1 month prior to the study
- Use of tobacco products over the past 6 months
- Unstable weight
- Individuals with allergies to eggs, wheat, nuts, soy and latex
- Individuals with phenylketonuria (PKU)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Methionine restricted diet
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.
|
Methionine restricted diet: 70% or 90% restriction Methionine and cysteine restricted diet: 50% or 65% restriction
|
EXPERIMENTAL: Methionine and cysteine restricted diet
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.
|
Methionine restricted diet: 70% or 90% restriction Methionine and cysteine restricted diet: 50% or 65% restriction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Body weight, plasma sulfur amino acids
Time Frame: Baseline, four weeks
|
Baseline, four weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Biomarkers of oxidative stress, blood lipids
Time Frame: Baseline, four weeks
|
Baseline, four weeks
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasma IGF1, insulin
Time Frame: Baseline, four weeks
|
Baseline, four weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: John P Richie, PhD, Penn State University
- Principal Investigator: Sailendra Nichenametla, Ph.D., Orentreich Foundation for the Advancement of Science, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 16, 2014
Primary Completion (ACTUAL)
July 1, 2016
Study Completion (ACTUAL)
July 1, 2017
Study Registration Dates
First Submitted
July 14, 2014
First Submitted That Met QC Criteria
July 14, 2014
First Posted (ESTIMATE)
July 16, 2014
Study Record Updates
Last Update Posted (ACTUAL)
September 7, 2020
Last Update Submitted That Met QC Criteria
September 4, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 03-13-2014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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