Clinical trial NCT02192437: Dietary Methionine and Cysteine Restriction in Healthy Adults
Official title: Dietary Methionine and Cysteine Restriction in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: methionine
cysteine
sulfur amino acid restriction
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: Orentreich Foundation for the Advancement of Science, Inc.
First posted: 2014-07-16
Enrollment: 20
Sex: ALL
Minimum age (years): 24
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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)

Primary outcomes:
measure: Body weight, plasma sulfur amino acids
timeFrame: Baseline, four weeks
Secondary outcomes:
measure: Biomarkers of oxidative stress, blood lipids
timeFrame: Baseline, four weeks
Other outcomes:
measure: Plasma IGF1, insulin
timeFrame: Baseline, four weeks
Locations:
city: State College
country: United States
facility: Penn State University
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: John P Richie, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Orentreich Foundation for the Advancement of Science, Inc.
name: Sailendra Nichenametla, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: