Recruiting

Metabolism Research

Sponsor:

Texas A&M University

Code:

NCT05400733

Conditions

Protein Metabolism

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Accepted

Interventions

Total Amino Acids

Essential Amino Acids

Essential Amino Acids + Hydroxy-methylbutyric acid (HMB)

Essential Amino Acids + Leucine

Essential Amino Acids High

Study Details

Brief summary:

Previous studies suggest that changes in metabolism due to the effects of aging might serve as a potential for therapeutic agents. The investigating lab developed a pulse method combining multiple stable isotopes to study multiple metabolic pathways in the same individual simultaneously. By measuring whole-body metabolism in a large group of older adults, the investigators may be able to unravel age-related deterioration in protein turnover (synthesis and breakdown) that contributes to impaired functional capacity. Metabolic profiles could explain differences in pathways in the aging process with special interest in metabolism of amino acids as they have been associated with aging-related disorders.

Conditions

Protein Metabolism

Study ID

NCT05400733

Start date

Jun 24, 2022

Status verified date

Sep, 2025

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age: 60-80, inclusive
  • Stable body-weight (± 5%) for the past 3 months
  • Subject is judged to be in satisfactory health based on medical history, physical examination, and laboratory screening evaluations.
  • Ability to walk, sit down and stand up independently or with walking mobility aids
  • Ability to lie in supine or elevated position for up to 7 hours
  • Willingness and ability to comply with the protocol

Exclusion Criteria:

  • Established diagnosis of current malignancy
  • History of untreated metabolic diseases including hepatic or renal disorder
  • Presence of acute illness or metabolically unstable chronic illness
  • Presence of fever within the last 3 days
  • Use of short course of oral corticosteroids within 4 weeks preceding study day
  • (Possible) pregnancy
  • Failure to give informed consent or Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
  • Already enrolled in another clinical trial and that clinical trial interferes with participating in this study
  • Any other condition according to the PI or nurse that was found during the screening visit, that would interfere with the study or safety of the patient

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Healthy male older adults

Healthy male older adults

other: Healthy female older adults

Healthy female older adults

Interventions

Total Amino Acids

Histidine, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartate, Cystine, Glutamine, Glutamate, Glycine, Proline, Serine, Tyrosine. All supplements are commercially available.

Essential Amino Acids

Histidine, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine. All supplements are commercially available.

Essential Amino Acids + Hydroxy-methylbutyric acid (HMB)

Histidine, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, HMB. All supplements are commercially available.

Essential Amino Acids + Leucine

Histidine, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Extra leucine. All supplements are commercially available.

Essential Amino Acids High

Histidine, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine. All supplements are commercially available.

Placebo Water

Water

Primary outcome measure

  • Feeding related changes in whole-body protein and amino acid metabolism [ Time Frame: up to 6 hours ]

Central Contacts and Locations

Central contacts

Marielle Engelen

9792202282mpkj.engelen@ctral.org

Savanah Knezek

9793186010s.knezek@ctral.org

Locations

Human Clinical Research Facility

Recruiting

College Station, Texas, United States, 77843

Contacts

Marielle Engelen, Ph.D.

hcrf@tamu.edu

Principal Investigator:

Marielle Engelen, Ph.D.

More Information

Sponsor

Texas A&M University

Last update posted

Oct 1, 2025

Last verified

Sep, 2025

Keywords

  • prandial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-29. This information was provided to ClinicalTrials.gov by Texas A&M University on 2025-10-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.