Dietary Methionine and Cysteine Restriction in Healthy Adults

• ClinicalTrials.gov Identifier: NCT02192437
• Recruitment Status: Completed
• First Posted: July 16, 2014
• Last Update Posted: September 7, 2020
• Sponsor: Milton S. Hershey Medical Center
• Collaborator: Orentreich Foundation for the Advancement of Science, Inc.
• Information provided by (Responsible Party): John P. Richie, Milton S. Hershey Medical Center

Study Description

Brief Summary:

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 .

Condition or disease	Intervention/treatment	Phase
Healthy	Other: Sulfur amino acid restricted diet	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Dietary Methionine and Cysteine Restriction in Healthy Adults
• Actual Study Start Date: July 16, 2014
• Actual Primary Completion Date: July 2016
• Actual Study Completion Date: July 2017

Arms and Interventions

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.	Other: Sulfur amino acid restricted diet; 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.	Other: Sulfur amino acid restricted diet; Methionine restricted diet: 70% or 90% restriction Methionine and cysteine restricted diet: 50% or 65% restriction

Outcome Measures

Primary Outcome Measures :

1. Body weight, plasma sulfur amino acids [ Time Frame: Baseline, four weeks ]

Secondary Outcome Measures :

1. Biomarkers of oxidative stress, blood lipids [ Time Frame: Baseline, four weeks ]

Other Outcome Measures:

1. Plasma IGF1, insulin [ Time Frame: Baseline, four weeks ]

Eligibility Criteria

• Ages Eligible for Study: 24 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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)

Contacts and Locations

Locations

United States, Pennsylvania

Penn State University

State College, Pennsylvania, United States, 16802

Sponsors and Collaborators

Milton S. Hershey Medical Center

Orentreich Foundation for the Advancement of Science, Inc.

Investigators

• Principal Investigator: John P Richie, PhD; Penn State University
• Principal Investigator: Sailendra Nichenametla, Ph.D.; Orentreich Foundation for the Advancement of Science, Inc.

More Information

• Responsible Party: John P. Richie, Professor of Public Health Sciences & Pharmacology, Milton S. Hershey Medical Center
• ClinicalTrials.gov Identifier: NCT02192437
• Other Study ID Numbers: 03-13-2014
• First Posted: July 16, 2014
• Last Update Posted: September 7, 2020
• Last Verified: September 2020

Keywords provided by John P. Richie, Milton S. Hershey Medical Center:

methionine; cysteine; sulfur amino acid restriction