Oral Supplement and Acute Resistance Exercise

NCT06801951 | Completed

• 1 other identifier: 2017-0655
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This study should provide the mechanistic basis for and evaluation of a new nutritional formulation to be used alongside exercise training to improve muscle function and exercise performance by minimizing exercise induced metabolic deregulation in patients with Chronic Obstructive Pulmonary Disease.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

oral nutrition supplement; resistance exercise

Outcome Measures

Primary Outcomes (1)

• net whole body protein metabolism synthesis

  Change in whole-body protein synthesis rate and myofibrillar protein breakdown

  2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes

Study Arms (2)

EAA + HMB

EXPERIMENTAL

Targeted amino acid formulation (7.0 g EAA and 1.5 g HMB (EAA+HMB))

Other: acute resistance exercise with oral nutrition supplementation; Other: stable tracer infusion

Placebo

PLACEBO COMPARATOR

7.0 gram non-essential amino acids

Other: acute resistance exercise with oral nutrition supplementation; Other: stable tracer infusion

Interventions

acute resistance exercise with oral nutrition supplementation OTHER

acute bout of resistance exercise on an isokinetic exercise machine of each limb (i.e., right and left arm and right and left leg) allowing control of velocity and force. Immediately upon completion, 1 serving of liquid nutrition supplement will be consumed. An additional serving of the liquid nutrition supplement will be sent home for consumption in the evening.

EAA + HMB; Placebo

stable tracer infusion OTHER

stable isotopes Such as L-\[ring-13C6\]-Phenylalanine, L-\[ring-D4\]Tyrosine, L-\[Methyl-D3\]Tau-Methylhistidine, trans-\[2,5,5-D3\]4-Hydroxy-L-proline, L-\[Guanido-15N2\]-Arginine, L-\[4,4,5,5-D4-5-13C\]Citruline, L-13C5 -Ornithine, L-15N2-Glutamine, L-\[1,2-13C2\]Glutamic Acid, 1-13C-Glycine, L-15N3-Histidine, L-13C6-Leucine, L-\[methyl-D3\]Methionine, α-1-13C-ketoisocaproic acid, L-1-13C-Methionine, DL-\[3,3,4,4-D4\]Homocysteine, L-\[1,2-13C2\]Taurine, L-(Indole-D5)Tryptophan, 13C-Urea, L-1-13C-Isoleucine, L-13C5-Valine, α-\[Dimethyl-13C2\]ketoisovaleric acid, 2-keto-3-methyl-13C6-pentanoate, 3-hydroxy-\[3,4-methyl-13C3\]isovaleric acid, 13C3-glycerol is given IV simultaneously

EAA + HMB; Placebo

Eligibility Criteria

• Age: 45 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to walk, sit down and stand up independently
• Age 45 - 100 years
• Willing to lay in bed for 4 hours during study visits
• Diagnosis of moderate to very severe chronic airflow limitation and compliant to the following criteria: FEV1 \< 70% of reference FEV1
• Clinically stable condition and not suffering from a respiratory tract infection or exacerbation of their disease (defined as a combination of increased cough, sputum purulence, shortness of breath, systemic symptoms such as fever, and a decrease in FEV1 \> 10% compared with values when clinically stable in the preceding year) at least 4 weeks prior to the first test day
• Shortness of breath on exertion
• Willingness and ability to comply with the protocol
• Healthy male or female according to the investigator's or appointed staff's judgment
• Ability to walk, sit down and stand up independently
• Age 45 - 100 years
• Willing to lay in bed for 4 hours during long study visits
• No diagnosis of COPD
• Willingness and ability to comply with the protocol

You may not qualify if:

• Any condition that may interfere with the definition 'healthy subject' according to the investigator's judgment (healthy subjects only)
• Subjects 86 years and older that fail to get physician eligibility confirmation
• Established diagnosis of Insulin dependent diabetes mellitus
• Established diagnosis of 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
• Dietary or lifestyle characteristics:
• Use of protein or amino acid containing nutritional supplements within 5 days of first test day
• Indications related to interaction with study products:
• Known allergy or sensitivity to milk or milk products
• Previous injury that could interfere with participation in resistance exercise protocol
• Failure to give informed consent or Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
• (Possible) pregnancy

Sponsors & Collaborators

• Texas A&M University: lead

Study Sites (1)

Texas A&M University-CTRAL

College Station, Texas, 77843-4253, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: January 30, 2025
• Study Start: December 11, 2017
• Primary Completion: February 27, 2020
• Study Completion: February 27, 2020
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)