Dietary Methionine and Cysteine Restriction in Healthy Adults

NCT02192437 | Completed DMC

• 1 other identifier: 03-13-2014
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 .

Conditions

Healthy

Keywords

methionine; cysteine; sulfur amino acid restriction

Outcome Measures

Primary Outcomes (1)

• Body weight, plasma sulfur amino acids

  Baseline, four weeks

Secondary Outcomes (1)

• Biomarkers of oxidative stress, blood lipids

  Baseline, four weeks

Other Outcomes (1)

• Plasma IGF1, insulin

  Baseline, four weeks

Study Arms (2)

Methionine restricted diet

EXPERIMENTAL

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 and cysteine restricted diet

EXPERIMENTAL

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

Interventions

Sulfur amino acid restricted diet OTHER

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

Methionine and cysteine restricted diet; Methionine restricted diet

Eligibility Criteria

• Age: 24 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• Orentreich Foundation for the Advancement of Science, Inc.: collaborator

Study Sites (1)

Penn State University

State College, Pennsylvania, 16802, United States

Location

Study Officials

• John P Richie, PhD

  Penn State University

  PRINCIPAL INVESTIGATOR

• Sailendra Nichenametla, Ph.D.

  Orentreich Foundation for the Advancement of Science, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Public Health Sciences & Pharmacology

Study Record Dates

• First Submitted: July 14, 2014
• First Posted: July 16, 2014
• Study Start: July 16, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2017
• Last Updated: September 7, 2020

Record last verified: 2020-09

Locations

US (1)