Prandial Metabolic Phenotype in Adults

Phase

N/A

Condition

N/A

Treatment

Essential Amino Acids + Hydroxy-methylbutyric acid (HMB)

Essential Amino Acids + Leucine

Essential Amino Acids High

Clinical Study ID

NCT05400733

83 - Pulse Feeding

Ages 60-80
All Genders
Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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, physicalexamination, 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

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 willingnessor ability of the subject to comply with the protocol requirements
Already enrolled in another clinical trial and that clinical trial interferes withparticipating in this study
Any other condition according to the PI or nurse that was found during the screeningvisit, that would interfere with the study or safety of the patient

Study Design

Essential Amino Acids + Hydroxy-methylbutyric acid (HMB)

June 24, 2022

September 30, 2026

Study 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.

Connect with a study center

Human Clinical Research Facility
College Station, Texas 77843
United States
Site Not Available
Human Clinical Research Facility
College Station 4682464, Texas 4736286 77843
United States
Active - Recruiting

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