Dietary Methionine and Cysteine Restriction in Healthy Adults

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Sulfur amino acid restricted diet

• Registration Number: NCT02192437
• Lead Sponsor: Milton S. Hershey Medical Center

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.

Study Timeline

• Study First Submitted: 2014-07-14
• Study First Submitted QC: 2014-07-14
• Study Start: 2014-07-16
• Study First Posted: 2014-07-16
• Primary Completion: 2016-07
• Study Completion: 2017-07
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-04
• Last Update Posted: 2020-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methionine restricted diet	Sulfur amino acid 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 and cysteine restricted diet	Sulfur amino acid 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.

Primary Outcome Measures

Name	Time	Method
Body weight, plasma sulfur amino acids	Baseline, four weeks

Secondary Outcome Measures

Name	Time	Method
Biomarkers of oxidative stress, blood lipids	Baseline, four weeks

Trial Locations

Locations (1)

Penn State University; 🇺🇸 State College, Pennsylvania, United States