Prandial Metabolic Phenotype in Adults

NCT05400733 | Recruiting

• 1 other identifier: 83 - Pulse Feeding
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

prandial

Outcome Measures

Primary Outcomes (1)

• Feeding related changes in whole-body protein and amino acid metabolism

  Whole-body production rate measured after stable tracer administration

  up to 6 hours

Study Arms (2)

Healthy male older adults

OTHER

Healthy male older adults

Dietary Supplement: Total Amino Acids; Dietary Supplement: Essential Amino Acids; Dietary Supplement: Essential Amino Acids + Hydroxy-methylbutyric acid (HMB); Dietary Supplement: Essential Amino Acids + Leucine; Dietary Supplement: Essential Amino Acids High; Dietary Supplement: Placebo Water

Healthy female older adults

OTHER

Healthy female older adults

Dietary Supplement: Total Amino Acids; Dietary Supplement: Essential Amino Acids; Dietary Supplement: Essential Amino Acids + Hydroxy-methylbutyric acid (HMB); Dietary Supplement: Essential Amino Acids + Leucine; Dietary Supplement: Essential Amino Acids High; Dietary Supplement: Placebo Water

Interventions

Total Amino Acids DIETARY_SUPPLEMENT

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

Healthy female older adults; Healthy male older adults

Essential Amino Acids DIETARY_SUPPLEMENT

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

Healthy female older adults; Healthy male older adults

Essential Amino Acids + Hydroxy-methylbutyric acid (HMB) DIETARY_SUPPLEMENT

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

Healthy female older adults; Healthy male older adults

Essential Amino Acids + Leucine DIETARY_SUPPLEMENT

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

Healthy female older adults; Healthy male older adults

Essential Amino Acids High DIETARY_SUPPLEMENT

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

Healthy female older adults; Healthy male older adults

Placebo Water DIETARY_SUPPLEMENT

Water

Healthy female older adults; Healthy male older adults

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas A&M University: lead

Study Sites (1)

Human Clinical Research Facility

College Station, Texas, 77843, United States

RECRUITING

Related Publications (1)

• Deutz NEP, Knezek SB, Engelen MPKJ. A novel pulse tracer method to estimate the relationship between amino acid meal composition and its intracellular disposal. Clin Nutr. 2025 Dec;55:196-207. doi: 10.1016/j.clnu.2025.10.002. Epub 2025 Oct 22.

  PMID: 41260190 DERIVED

MeSH Terms

Interventions

Amino Acids, Essential; Leucine

Intervention Hierarchy (Ancestors)

Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Branched-Chain

Central Study Contacts

Marielle Engelen

CONTACT

9792202282; mpkj.engelen@ctral.org

Savanah Knezek

CONTACT

9793186010; s.knezek@ctral.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: June 2, 2022
• Study Start: June 24, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

US (1)