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Chronic Heart FailureNCT01787682

Nutritional and Functional Changes in Heart Failure and COPD

A study testing BOOST High Protein in people with Chronic Heart Failure and Chronic Obstructive Pulmonary Disorder, run by Texas A&M University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Weight loss commonly occurs in patients with chronic heart failure (CHF) and chronic obstructive pulmonary disorder (COPD), negatively influencing their quality of life, treatment response and survival. Read more about this study

Who is it for?
Ages 20 years and olderHealthy volunteers can take part
What is being tested?
BOOST High Protein
Could I receive a placebo?
No, everyone receives an active treatment
How many people
99 participants
Where
1 siteUnited States
Study dates
Dec 2012to 17 Sep 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Ability to walk, sit down and stand up independently
  • Age 45 years or older
  • Ability to lie in supine or elevated position for 7 hours
  • Diagnosis of Chronic Heart Failure; under regular care by cardiologist
  • NYHA class II-IV
  • Reduced ejection fraction (<45%) assessed in the past 2 years
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  • Clinically stable condition; no hospitalization 4 weeks preceding first study day
  • Willingness and ability to comply with the protocol
  • Ability to walk, sit down and stand up independently
  • Age 45 years or older
  • Ability to lie in supine or elevated position for 8 hours
  • 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 years or older (older control group)
  • Age between 20-30 years old (young group)
  • Ability to lay in supine or elevated position for 7 hours
  • No diagnosis of CHF
  • Willingness and ability to comply with the protocol

Who cannot join

  • Any condition that may interfere with the definition 'healthy subject' according to the investigator's judgment (healthy subjects only)
  • 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
  • Body mass index >40 kg/m2 (healthy subjects only)
  • 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
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  • Use of protein or amino acid containing nutritional supplements within 5 days of first study day
  • Current use of long-term oral corticosteroids (CHF only)
  • Use of short course of oral corticosteroids within 4 weeks preceding first study day
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Texas A&M University

    College Station, Texas, 77843

Other trials in United States

About this study

Official title: Metabolic and Functional Changes in Relation to Nutritional Status in Chronic Heart Failure and Chronic Obstructive Pulmonary Disorder

Weight loss commonly occurs in patients with chronic heart failure (CHF) and chronic obstructive pulmonary disorder (COPD), negatively influencing their quality of life, treatment response and survival. Loss of muscle protein is generally a central component of weight loss in CHF and COPD patients but patients also have reductions in fat mass and bone density, independent of the severity of the disease state. The purpose of this cross-sectional study is to provide detailed insight in disease related gut function by obtaining information on gut permeability, digestion and absorption of glucose, fat and protein in CHF and COPD patients compared to matched healthy controls. This will provide required information that is necessary to implement new strategies to develop optimal nutritional regimen in CHF and COPD. The hypothesis is that CHF and COPD are related to decreased gut function and absorption, leading to decreased anabolic response. Second, this decreased nutritional status is linked to reduced muscle functioning and possibly decreased cognition. In addition, we will examine the effect of aging on by comparing gut function digestion and absorption of the CHF and COPD aged matched healthy controls to a group of young healthy subjects.

Read the detailed description

This study involves one test day of approximately 7-8 hours. On this test day subjects will ingest a sugar drink to assess gut permeability and gut function, and a protein meal to measure digestion/absorption and the anabolic response to food intake. Subjects will also receive a mixture of amino acids that are made a little heavier than normal, called stable isotopes. This stable isotopes is used to investigate protein behavior in the body (protein kinetics). Blood (100-120 ml in total) and urine samples will be collected over 7 hours.

Being tested
BOOST High Protein
Keywords
CHF, Protein digestion, Fat digestion, Gut function, Glucose absorption, Muscle function

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BOOST High ProteinDietary supplement

Study groups in NCT01787682
Study groupRoleWhat they receive
Boost High ProteinExperimentalBoost high protein with added spirulina
Receives: Dietary Supplement: BOOST High Protein

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Net whole-body protein synthesis

    change in whole-body protein synthesis rate after intake of meal

    Measured: 0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 min post-meal

Secondary outcomes (15)

  1. Citrulline Rate of appearance

    plasma enrichment of citrulline

    Measured: Postabsorptive state during 2 hours

  2. Glucose absorption

    Recovery of 3-O-Methyl-D-glucose in the urine.

    Measured: 7 hours

  3. Gut permeability

    recovery of rhamnose/lactulose in urine

    Measured: 7 hours

  4. Skeletal and respiratory muscle strength

    Difference in leg strength and fatigue, handgrip strength and fatigue, and inspiratory and expiratory pressure between heart failure patients and healthy controls.

    Measured: 1 day

  5. Cognitive function

    Outcome of neuro-psychological tests in heart failure patients and healthy controls in relation to the tryptophan metabolism

    Measured: 1 day

  6. Fatty acid digestion after feeding

    Enrichment in palmitic acid and tripalmitin fatty acids in plasma

    Measured: 0,15,30,45,60,75,90,105,120,150,180,210 min post-meal

  7. Protein digestion after feeding

    Ratio enrichment free phenylalanine vs phenylalanine from protein spirulina

    Measured: 0,15,30,45,60,75,90,105,120,150,180,210, min post-meal

  8. Arginine turnover rate

    Arginine enrichment in plasma

    Measured: postabsorptive state during 3 hours

  9. Whole body collagen breakdown rate

    Hydroxyproline enrichment in plasma

    Measured: Postabsorptive state during 3 hours

  10. Tryptophan turnover rate

    Tryptophan enrichment in plasma

    Measured: Postabsorptive state during 3 hours

  11. Insulin response to feeding

    Acute change from postabsorptive state after intake of meal

    Measured: during 3 hours after feeding

  12. Fat-free mass

    Characteristics of study subjects

    Measured: postabsorptive state during 15 min

  13. Myofibrillar protein breakdown rate

    3methylhistidine enrichment in plasma

    Measured: 0,15,30,45,60,75,90,105,120,150,180,210 min post-meal

  14. Glycine rate of appearance

    glycine enrichment in plasma

    Measured: Postabsorptive state during 3 hours

  15. Taurine turnover rate

    enrichment of taurine in

    Measured: postabsorptive state during 3 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2013 (estimated)
  2. Study startDec 2012
  3. Primary completion17 Sep 2017
  4. Study completion17 Sep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01787682
Sponsor's protocol ID
2012-0503
Status last verified
Feb 2022
First submitted
4 Feb 2013
Last updated
7 Feb 2022
Results posted
No
Data monitoring committee
No

Publications

  • Huttl VN, Deutz N, Wierzchowska-McNew RA, Ruebush LE, Engelen M. Whole-body and intracellular arginine metabolism in hypertension: role of disease severity and sex. Am J Hypertens. 2026 May 18:hpag047. doi: 10.1093/ajh/hpag047. Online ahead of print.

    PubMed 42149813

  • Kang MC, Deutz NEP, Kirschner SK, Engelen MPKJ. Metabolic kinetics and muscle and brain health markers in older adults, and the role of age and presence of chronic morbidities: A large cross-sectional cohort study. Clin Nutr. 2024 Dec;43(12):36-47. doi: 10.1016/j.clnu.2024.10.015. Epub 2024 Oct 11.

    PubMed 39423760

  • Deutz LN, Wierzchowska-McNew RA, Deutz NE, Engelen MP. Reduced plasma glycine concentration in healthy and chronically diseased older adults: a marker of visceral adiposity? Am J Clin Nutr. 2024 Jun;119(6):1455-1464. doi: 10.1016/j.ajcnut.2024.04.008. Epub 2024 Apr 12.

    PubMed 38616018

  • Engelen MPKJ, Kirschner SK, Coyle KS, Argyelan D, Neal G, Dasarathy S, Deutz NEP. Sex related differences in muscle health and metabolism in chronic obstructive pulmonary disease. Clin Nutr. 2023 Sep;42(9):1737-1746. doi: 10.1016/j.clnu.2023.06.031. Epub 2023 Jul 26.

    PubMed 37542951

  • Wierzchowska-McNew RA, Engelen MPKJ, Thaden JJ, Ten Have GAM, Deutz NEP. Obesity- and sex-related metabolism of arginine and nitric oxide in adults. Am J Clin Nutr. 2022 Dec 19;116(6):1610-1620. doi: 10.1093/ajcn/nqac277.

    PubMed 36166849

  • Pinson MR, Deutz NEP, Harrykissoon R, Zachria AJ, Engelen MPKJ. Disturbances in branched-chain amino acid profile and poor daily functioning in mildly depressed chronic obstructive pulmonary disease patients. BMC Pulm Med. 2021 Nov 7;21(1):351. doi: 10.1186/s12890-021-01719-9.

    PubMed 34743729

  • Engelen MPKJ, Jonker R, Thaden JJ, Ten Have GAM, Jeon MS, Dasarathy S, Deutz NEP. Comprehensive metabolic flux analysis to explain skeletal muscle weakness in COPD. Clin Nutr. 2020 Oct;39(10):3056-3065. doi: 10.1016/j.clnu.2020.01.010. Epub 2020 Jan 29.

    PubMed 32035752

  • Deutz NEP, Thaden JJ, Ten Have GAM, Walker DK, Engelen MPKJ. Metabolic phenotyping using kinetic measurements in young and older healthy adults. Metabolism. 2018 Jan;78:167-178. doi: 10.1016/j.metabol.2017.09.015. Epub 2017 Oct 3.

    PubMed 28986165

Questions about this trial

What is this clinical trial studying?

A study testing BOOST High Protein in people with Chronic Heart Failure and Chronic Obstructive Pulmonary Disorder, run by Texas A&M University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Net whole-body protein synthesis (time frame: 0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 min post-meal). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01787682, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2022.

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