Dietary Methionine and Cysteine Restriction in Healthy Adults

NCT ID: NCT02192437

Last Updated: 2020-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-16
• Study Completion Date: 2017-07-31

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 .

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Sulfur amino acid restricted diet

Intervention Type: OTHER

Methionine restricted diet: 70% or 90% restriction Methionine and cysteine restricted diet: 50% or 65% restriction

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.

Group Type: EXPERIMENTAL

Sulfur amino acid restricted diet

Intervention Type: OTHER

Methionine restricted diet: 70% or 90% restriction Methionine and cysteine restricted diet: 50% or 65% restriction

Interventions

Sulfur amino acid restricted diet

Methionine restricted diet: 70% or 90% restriction Methionine and cysteine restricted diet: 50% or 65% restriction

Intervention Type: OTHER

Eligibility 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)

• Minimum Eligible Age: 24 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Orentreich Foundation for the Advancement of Science, Inc.

OTHER

Sponsor Role: collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

John P. Richie

Professor of Public Health Sciences & Pharmacology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John P Richie, PhD

Role: PRINCIPAL_INVESTIGATOR

Penn State University

Sailendra Nichenametla, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Orentreich Foundation for the Advancement of Science, Inc.

Locations

Penn State University

State College, Pennsylvania, United States

Countries

United States

Other Identifiers

03-13-2014

Identifier Type: -

Identifier Source: org_study_id