Prandial Metabolic Phenotype in Adults

• Sponsor: Texas A&M University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05400733
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 9.5
• Patients Per Site Per Month: 5.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Protein Metabolism	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	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• Official Title: Prandial Metabolic Phenotype in Adults
• Anticipated Study Start Date: Jun 15, 2022
• Anticipated Primary Completion Date: Apr 1, 2023
• Anticipated Study Completion Date: Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Healthy male older adults Healthy male older adults	Dietary Supplement: 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.; Dietary Supplement: Essential Amino Acids; Histidine, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine. All supplements are commercially available.; Dietary Supplement: Essential Amino Acids + Hydroxy-methylbutyric acid (HMB); Histidine, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, HMB. All supplements are commercially available.; Dietary Supplement: Essential Amino Acids + Leucine; Histidine, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Extra leucine. All supplements are commercially available.; Dietary Supplement: Essential Amino Acids High; Histidine, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine. All supplements are commercially available.; Dietary Supplement: Placebo Water; Water
Other: Healthy female older adults Healthy female older adults	Dietary Supplement: 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.; Dietary Supplement: Essential Amino Acids; Histidine, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine. All supplements are commercially available.; Dietary Supplement: Essential Amino Acids + Hydroxy-methylbutyric acid (HMB); Histidine, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, HMB. All supplements are commercially available.; Dietary Supplement: Essential Amino Acids + Leucine; Histidine, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Extra leucine. All supplements are commercially available.; Dietary Supplement: Essential Amino Acids High; Histidine, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine. All supplements are commercially available.; Dietary Supplement: Placebo Water; Water

Outcome Measures

Primary Outcome Measures

1. Feeding related changes in whole-body protein and amino acid metabolism [up to 6 hours]

   Whole-body production rate measured after stable tracer administration

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Human Clinical Research Facility	College Station	Texas	United States	77843

Sponsors and Collaborators

• Texas A&M University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marielle PKJ Engelen, PhD, Professor, Texas A&M University
• ClinicalTrials.gov Identifier: NCT05400733
• Other Study ID Numbers: 83 - Pulse Feeding
• First Posted: Jun 2, 2022
• Last Update Posted: Jun 6, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Marielle PKJ Engelen, PhD, Professor, Texas A&M University: prandial

Study Results

No Results Posted as of Jun 6, 2022