Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-25 @ 9:42 PM
Study NCT ID:
NCT06801951
Status:
COMPLETED
Last Update Posted:
2025-01-30
First Post:
2025-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Oral Supplement and Acute Resistance Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2020-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-24', 'studyFirstSubmitDate': '2025-01-24', 'studyFirstSubmitQcDate': '2025-01-24', 'lastUpdatePostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'net whole body protein metabolism synthesis', 'timeFrame': '2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes', 'description': 'Change in whole-body protein synthesis rate and myofibrillar protein breakdown'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['oral nutrition supplement', 'resistance exercise'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Our central hypothesis is that improving the metabolic response to resistance exercise via targeted nutritional modulation with EAA enriched with HMB (EAA+HMB) will increase the gain in muscle function and exercise performance by positively influencing skeletal muscle protein homeostasis among severe COPD patients. Our rationale for the proposed research is that detailed insight in the mechanisms by which resistance exercise induces metabolic deregulations in severe COPD patients, and demonstration of the effectiveness of targeted nutritional intervention will provide opportunities for the development of innovative safe and effective nutritional approaches to improve their training response and skeletal muscle repair, leading to increased daily life physical activity. Furthermore, the proposed studies will provide supportive data of, and focus for a subsequent phase 2b/3 clinical trial to improve quality of life, and clinical outcomes of severe COPD patients. We propose to study simultaneously the following specific aim:\n\nInvestigate the metabolic mechanisms by which resistance exercise induces protein catabolism in severe COPD patients as compared to healthy age and gender matched control subjects. Our working hypothesis is that patients with severe COPD (GOLD II-IV) have a metabolic signature that relates to their late (24h) post-exercise catabolic response. We will utilize an innovative IV tracer pulse approach of \\> 15 labeled amino acids to enable kinetic analysis of their intracellular production, disposal and interconversion rates (fluxomics), and quantify the rates of muscle protein synthesis and breakdown.\n\nThe liquid nutrition supplement will be either targeted amino acid formulation (7.0 g EAA and 1.5 g HMB (EAA+HMB)) or placebo (7.0 gram non-essential amino acids). Liquid nutrition supplement will be given to subjects according to a randomized, placebo controlled, double blind, cross-over design.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria COPD subjects:\n\nAbility to walk, sit down and stand up independently\n\nAge 45 - 100 years\n\nWilling to lay in bed for 4 hours during study visits\n\nDiagnosis of moderate to very severe chronic airflow limitation and compliant to the following criteria: FEV1 \\< 70% of reference FEV1\n\nClinically 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\n\nShortness of breath on exertion\n\nWillingness and ability to comply with the protocol\n\nInclusion criteria control subjects:\n\nHealthy male or female according to the investigator's or appointed staff's judgment\n\nAbility to walk, sit down and stand up independently\n\nAge 45 - 100 years\n\nWilling to lay in bed for 4 hours during long study visits\n\nNo diagnosis of COPD\n\nWillingness and ability to comply with the protocol\n\nExclusion Criteria all subjects:\n\nAny condition that may interfere with the definition 'healthy subject' according to the investigator's judgment (healthy subjects only)\n\nSubjects 86 years and older that fail to get physician eligibility confirmation\n\nEstablished diagnosis of Insulin dependent diabetes mellitus\n\nEstablished diagnosis of malignancy\n\nHistory of untreated metabolic diseases including hepatic or renal disorder\n\nPresence of acute illness or metabolically unstable chronic illness\n\nPresence of fever within the last 3 days\n\nUse of short course of oral corticosteroids within 4 weeks preceding study day\n\nDietary or lifestyle characteristics:\n\nUse of protein or amino acid containing nutritional supplements within 5 days of first test day\n\nIndications related to interaction with study products:\n\nKnown allergy or sensitivity to milk or milk products\n\nPrevious injury that could interfere with participation in resistance exercise protocol\n\nFailure to give informed consent or Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements\n\n(Possible) pregnancy\n\nAlready enrolled in another clinical trial and that clinical trial interferes with participating in this study\n\nAny 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"}, 'identificationModule': {'nctId': 'NCT06801951', 'acronym': 'HMB exercise', 'briefTitle': 'Oral Supplement and Acute Resistance Exercise', 'organization': {'class': 'OTHER', 'fullName': 'Texas A&M University'}, 'officialTitle': 'Effects of Oral Nutritional Supplement and Acute Resistance Exercise in Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': '2017-0655'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EAA + HMB', 'description': 'Targeted amino acid formulation (7.0 g EAA and 1.5 g HMB (EAA+HMB))', 'interventionNames': ['Other: acute resistance exercise with oral nutrition supplementation', 'Other: stable tracer infusion']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '7.0 gram non-essential amino acids', 'interventionNames': ['Other: acute resistance exercise with oral nutrition supplementation', 'Other: stable tracer infusion']}], 'interventions': [{'name': 'acute resistance exercise with oral nutrition supplementation', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['EAA + HMB', 'Placebo']}, {'name': 'stable tracer infusion', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['EAA + HMB', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77843-4253', 'city': 'College Station', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas A&M University-CTRAL', 'geoPoint': {'lat': 30.62798, 'lon': -96.33441}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Texas A&M University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Marielle PKJ Engelen, PhD', 'investigatorAffiliation': 'Texas A&M University'}}}}