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Ovagen

Glu-Asp-Leu, Liver Bioregulator Peptide

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Studies 34
Trials 30
Recruiting NA INTERVENTIONAL NCT05400733

Prandial Metabolic Phenotype in Adults

View on ClinicalTrials.gov Updated Dec 15, 2025

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.

Detailed Description

The study involves 1 screening visits of approximately 3 hours and 6 study days of approximately 8 hours. Subjects will be asked to arrive in the fasted state on all study days. Fasting prior to screening is not required. On the screening day, body weight, height, and body composition by Dual-energy X-ray absorptiometry (DXA) will be measured. In addition, The Six-Minute Walk Test (6MWT) and skeletal muscle function tests will be assessed at the end of each screening visit. Each study visit will begin with vital signs. Before administration of the feeding or the tracer solution, baseline blood will be collected for measurement of the natural enrichment of metabolites. After the baseline sample is collected, feeding will begin and will be followed by tracers of several compounds that may be administered by IV pulse. Next, the subjects will be fed one of six liquid nutritional supplement every 20 minutes for 6 hours. The liquid nutrition supplement will target the amino acid formulation in the following meals (1) total amino acid, (2) Essential Amino Acids (EAA), (3) EAA + -hydroxy -methylbutyric acid (HMB), (4) EAA + leucine (LEU), (5) EAA high, and (6) Placebo.

Interventions

Name: Total Amino Acids
Type: DIETARY_SUPPLEMENT
Description: Histidine, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartate, Cystine, Glutamine, Glutamate, Glycine, Proline, Serine, Tyrosine. All supplements are commercially available.
Name: Essential Amino Acids
Type: DIETARY_SUPPLEMENT
Description: Histidine, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine. All supplements are commercially available.
Name: Essential Amino Acids + Hydroxy-methylbutyric acid (HMB)
Type: DIETARY_SUPPLEMENT
Description: Histidine, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, HMB. All supplements are commercially available.
Name: Essential Amino Acids + Leucine
Type: DIETARY_SUPPLEMENT
Description: Histidine, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Extra leucine. All supplements are commercially available.
Name: Essential Amino Acids High
Type: DIETARY_SUPPLEMENT
Description: Histidine, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine. All supplements are commercially available.
Name: Placebo Water
Type: DIETARY_SUPPLEMENT
Description: Water

Primary Outcomes

Measure: Feeding related changes in whole-body protein and amino acid metabolism
TimeFrame: up to 6 hours
Description: Whole-body production rate measured after stable tracer administration

Trial Information

NCT ID

NCT05400733

Status

Recruiting

Study Type

INTERVENTIONAL

Phases

NA

Sponsor

Texas A&M University

Last Updated

December 15, 2025

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