The Need for FibEr Addition in SympTomatic Heart Failure (FEAST-HF)

FEAST-HF is a single-centre clinical trial in ambulatory patients with chronic HF to evaluate whether dietary supplementation with acacia gum reduces HF-related biomarkers NT-proBNP and ST2 and how the gut microbiome responds to dietary supplementation with acacia gum. The hypotheses of this study are 1) that changes in the gut microbiome will be correlated with a reduction in NT-proBNP and ST2 in patients with HF after treatment with acacia gum, and 2) gut microbiome configurations (composition, diversity), stability and function (gene content) will be significantly altered in patients with HF in response to acacia gum.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Dietary supplement: Acacia Gum

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • University of Calgary
    • Edmonton, Alberta, Canada, T5H 3V9
      • Royal Alexandra Hospital
    • Edmonton, Alberta, Canada, T6G 2B7
      • Mazankowski Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years of age or older
• Willing and able to provide informed consent
• Patients with established Heart Failure (as per their treating physician) including those with both reduced and preserved ejection fraction

Exclusion Criteria:

• Patients requiring a special diet that would prohibit the intervention (e.g. celiac disease, irritable bowel disease)
• Patients who do not control their own meals (e.g. meals-on-wheels, long-term care)
• Patients with conditions that would interfere with the analysis of the microbiome (e.g. chronic diarrhea, recent antibiotics within the past month)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Microcrystalline Cellulose (MCC) 10 grams/day; non-fermentable active control	Dietary supplement: Acacia Gum; dietary supplement will be added to the participant's usual diet
Experimental: Acacia Gum 5 grams/day; fermentable dietary fiber	Dietary supplement: Acacia Gum; dietary supplement will be added to the participant's usual diet
Experimental: Acacia Gum 10 grams/day; fermentable dietary fiber	Dietary supplement: Acacia Gum; dietary supplement will be added to the participant's usual diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NT-proBNP	change in NT-proBNP level	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Clinical Outcomes	All cause death, hospitalizations and emergency department visits	12 weeks
Quality of Life	Change in quality of life assessed by the Kansas City Cardiomyopathy Questionnaire	12 weeks
NYHA Functional Class	Change in NYHA class treated as a categorical variable	12 weeks
6-Minute Walk Test	Change in 6-Minute Walk test	12 weeks
Fecal Microbiome Characterization	To examine the gut microbiome in a descriptive manner and characterize predominant species and those linked to Short Chain Fatty Acid production	Baseline, Week 6, Week 12
ST-2	change in ST-2 level	12 weeks

Collaborators and Investigators

• Sponsor: University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2018
• Primary Completion (Actual): January 10, 2022
• Study Completion (Actual): January 10, 2022

Study Registration Dates

• First Submitted: January 18, 2018
• First Submitted That Met QC Criteria: January 23, 2018
• First Posted (Actual): January 24, 2018

Study Record Updates

• Last Update Posted (Actual): August 18, 2022
• Last Update Submitted That Met QC Criteria: August 16, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Microbiome; Cardiovascular Disease; Fiber; Diet; Heart Disease
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: Pro00078692

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No