Nutritional Therapy Interventions in Heart Failure

NCT ID: NCT03424265

Last Updated: 2021-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-15
• Study Completion Date: 2019-06-27

Brief Summary

The investigators will examine the effects of 12-weeks of nutritional interventions in older participants who have a symptom of mild to moderate heart failure.

Detailed Description

Heart failure develops when cardiac muscle becomes weakened and consequently is compromised in its ability to contract, relax, or both. Impaired heart function leads to reduced exercise capacity, which in turn leads to progressive muscle weakness and a vicious cycle of sedentary behavior, weight gain, and subsequent development of metabolic abnormalities and sarcopenia. Approximately 6-10% of individuals over the age of 65 suffer from heart failure, and the risk of death is 35% in the first year after diagnosis. In addition, there is a wide range of potential causes of heart failure, including the natural process of aging. Regardless of the specific underlying cause, there are common pathophysiological responses such as impaired exercise capacity, shortness of breath, fatigue and muscle strength, leading to decreased physical function. Moreover, some long-term consequences of reduced exercise tolerance and malabsorption in long-standing heart failure are loss of muscle mass and the development of cardiac cachexia, resulted in progression of sarcopenia. As protein and amino acid supplements are known to prevent loss of muscle mass or maintain muscle mass in alder individuals, in a pilot study 18 overweight/obese subjects with heart failure (all exceeded 40% body fat) were studied. Nine subjects received 12 weeks of dietary supplementation with 20 g of whey protein consumed daily, while the other nine were controls. The findings showed that supplementation with whey protein failed to improve functional performance as well as a limited stimulation of muscle protein synthesis. The lack of a demonstrable effect of whey protein is consistent with the diminished responsiveness to the stimulation of muscle protein synthesis. In contrast, a 2016 University of Arkansas for Medical Sciences (UAMS) pilot study found that the essential amino acid (EAA) mixture is better at overcoming anabolic resistance than Ensure Heart Health. In this study we will perform a randomized clinical trial of a commercially produced nutritional supplement as compared to a placebo in order to determine effects on physical function and health-related quality of life. Subjects will ingest either the EAA mixture product or placebo every day for 12 consecutive weeks. Outcomes will be determined by comparing the results of physical and functional tests from weeks -1 to 6 and 12.

Conditions

Heart Failure NYHA Class II

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

9g of EAA mixture supplement

Twice a day for 12 consecutive weeks.

Group Type: EXPERIMENTAL

EAA mixture

Intervention Type: DIETARY_SUPPLEMENT

Dietary supplement intervention for 12-weeks

9g of placebo (whey protein)

Twice a day for 12 consecutive weeks.

Group Type: EXPERIMENTAL

Placebo (whey protein)

Intervention Type: DIETARY_SUPPLEMENT

Dietary supplement intervention for 12-weeks

Interventions

EAA mixture

Dietary supplement intervention for 12-weeks

Intervention Type: DIETARY_SUPPLEMENT

Placebo (whey protein)

Dietary supplement intervention for 12-weeks

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Essential Blends, Fairbanks, Alaska; Pure Protein, 100% Whey Protein Powder, Bayport, NY

Eligibility Criteria

Inclusion Criteria

• BMI between 18 and 40 kg/m2
• Any ethnicity
• Presence of mild-to-moderate heart failure (NYHA II or III symptomatology) as evidenced by prescribed diuretics or reported shortness of breath upon exertion

Exclusion Criteria

• Allergic to milk or soy products
• Hemoglobin <10 g/dL
• Estimated Glomerular Filtration Rate (eGFR) < 30
• Inability to perform strength and/or functional assessments
• Myocardial infarction in the past 6 months
• Unstable angina
• Moderate-severe heart valve disease
• Atrial fibrillation or other significant (as determined by PI) arrhythmias
• Infiltrative, restrictive or hypertrophic cardiomyopathy
• Dementia -determined by a SLUMS score of <20
• Currently having inflammatory bowel disease
• Received chemotherapy or radiation therapy within the past 12 months
• Currently undergoing tube feeding
• Currently receiving palliative care for end-of-life circumstance
• Unwilling to refrain from using non-study protein/amino acid supplements during their participation in this study
• If deemed medically unstable by the study physician for any other reason.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gohar Azhar, M.D

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Countries

United States

References

Azhar G, Verma A, Zhang X, Pangle A, Patyal P, Zhang W, Che Y, Coker K, Wolfe RR, Wei JY. Differential plasma protein expression after ingestion of essential amino acid-based dietary supplement verses whey protein in low physical functioning older adults. Geroscience. 2023 Jun;45(3):1729-1743. doi: 10.1007/s11357-023-00725-5. Epub 2023 Feb 1.

Reference Type: DERIVED

PMID: 36720768 (View on PubMed)

Azhar G, Wei JY, Schutzler SE, Coker K, Gibson RV, Kirby MF, Ferrando AA, Wolfe RR. Daily Consumption of a Specially Formulated Essential Amino Acid-Based Dietary Supplement Improves Physical Performance in Older Adults With Low Physical Functioning. J Gerontol A Biol Sci Med Sci. 2021 Jun 14;76(7):1184-1191. doi: 10.1093/gerona/glab019.

Reference Type: DERIVED

PMID: 33475727 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

206313

Identifier Type: -

Identifier Source: org_study_id