NCT02566434

Brief Summary

Participants will receive four different doses of methionine through four month long interventions with a two week wash-out period in between intervention. The dose will increase with each intervention. Two visits during each intervention will also involve receiving stable isotope infusion to determine the metabolism of methionine in the body. Participants will also be monitored via blood work and questionnaires regarding overall health.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 2, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

September 26, 2018

Status Verified

September 1, 2018

Enrollment Period

9 months

First QC Date

September 21, 2015

Last Update Submit

September 25, 2018

Conditions

Healthy

Keywords

Dietary Supplements

Outcome Measures

Primary Outcomes (12)

  • Hepatic Function Panel--10 mg/kg body weight dose

    participants will be followed for the duration of the dose intervention, an expected average of 4 weeks

  • Metabolic Renal Function Panel--10 mg/kg body weight dose

    participants will be followed for the duration of the dose intervention, an expected average of 4 weeks

  • Complete Blood Count (CBC) With Differential--10 mg/kg body weight dose

    participants will be followed for the duration of the dose intervention, an expected average of 4 weeks

  • Hepatic Function Panel--25 mg/kg body weight dose

    participants will be followed for the duration of the dose intervention, an expected average of 4 weeks

  • Metabolic Renal Function Panel--25mg/kg body weight dose

    participants will be followed for the duration of the dose intervention, an expected average of 4 weeks

  • Complete Blood Count (CBC) With Differential--25 mg/kg body weight dose

    participants will be followed for the duration of the dose intervention, an expected average of 4 weeks

  • Hepatic Function Panel--50 mg/kg body weight dose

    participants will be followed for the duration of the dose intervention, an expected average of 4 weeks

  • Metabolic Renal Function Panel--50 mg/kg body weight dose

    participants will be followed for the duration of the dose intervention, an expected average of 4 weeks

  • Complete Blood Count (CBC) With Differential--50 mg/kg body weight dose

    participants will be followed for the duration of the dose intervention, an expected average of 4 weeks

  • Hepatic Function Panel--100 mg/kg body weight dose

    participants will be followed for the duration of the dose intervention, an expected average of 4 weeks

  • Metabolic Renal Function Panel--100 mg/kg body weight dose

    participants will be followed for the duration of the dose intervention, an expected average of 4 weeks

  • Complete Blood Count (CBC) With Differential--100 mg/kg body weight dose

    participants will be followed for the duration of the dose intervention, an expected average of 4 weeks

Secondary Outcomes (12)

  • Complete Aminogram--10 mg/kg body weight dose

    participants will be followed for the duration of the dose intervention, an expected average of 4 weeks

  • Glutathione ratio--10 mg/kg body weight dose

    participants will be followed for the duration of the dose intervention, an expected average of 4 weeks

  • Plasma Homocysteine concentration--10 mg/kg body weight dose

    participants will be followed for the duration of the dose intervention, an expected average of 4 weeks

  • Complete Aminogram--25 mg/kg body weight dose

    participants will be followed for the duration of the dose intervention, an expected average of 4 weeks

  • Glutathione ratio--25 mg/kg body weight dose

    participants will be followed for the duration of the dose intervention, an expected average of 4 weeks

  • +7 more secondary outcomes

Study Arms (1)

Methionine

EXPERIMENTAL

All participants will consume free methionine at 10 mg/kg body weight/day (=requirement), 25 mg/kg body weight/day, 50 mg/kg body weight/day and 100 mg/kg body weight/day for the duration of a 4-week intervention period. Participants will cease intake when signs of toxicity are measured in blood work.

Dietary Supplement: methionine

Interventions

methionineDIETARY_SUPPLEMENT

4 weeks intervention and 2 to 4 weeks washout in healthy volunteers with free methionine at 10 mg/kg body weight/day (=requirement), 25 mg/kg body weight/day, 50 mg/kg body weight/day and 100 mg/kg body weight/day.

Methionine

Eligibility Criteria

Age40 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be a healthy male or female according to the investigator's or appointed staff's judgment
  • Age 40 - 79 years.
  • Must be willing to lay in bed for 4 hours on the long study days (LD)
  • Have a stable body weight within the past 3 months (\< 5% change)

You may not qualify if:

  • History of cardiovascular disease
  • Metabolic diseases including hepatic or renal disorder
  • Presence of acute illness or metabolically unstable chronic illness
  • Unwilling to stop taking nutritional supplements containing proteins or free amino acids within 5 days of the first study day until study completion
  • Have not taken or participated in any nutritional supplement study program within the past 4 weeks
  • Any other condition according to the PI or nurse that would interfere with the study or safety of the subject or influence the results
  • Pregnancy
  • Unwilling to comply with any other rules set forth in the Informed Consent Form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas A&M University-CTRAL

College Station, Texas, 77845-4253, United States

Location

Related Publications (1)

  • Deutz NE, Simbo SY, Ligthart-Melis GC, Cynober L, Smriga M, Engelen MP. Tolerance to increased supplemented dietary intakes of methionine in healthy older adults. Am J Clin Nutr. 2017 Aug;106(2):675-683. doi: 10.3945/ajcn.117.152520. Epub 2017 Jun 21.

    PMID: 28637772DERIVED

MeSH Terms

Interventions

Methionine

Intervention Hierarchy (Ancestors)

Amino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino Acids, EssentialAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Neutral

Study Officials

  • Marielle Engelen

    Texas A&M University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 21, 2015

First Posted

October 2, 2015

Study Start

July 1, 2015

Primary Completion

April 1, 2016

Study Completion

October 1, 2017

Last Updated

September 26, 2018

Record last verified: 2018-09

Locations

US(1)