NCT03409926

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable heart-failure

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 24, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

September 13, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2022

Completed
Last Updated

August 18, 2022

Status Verified

August 1, 2022

Enrollment Period

3.3 years

First QC Date

January 18, 2018

Last Update Submit

August 16, 2022

Conditions

Heart Failure

Keywords

Heart DiseaseCardiovascular DiseaseDietFiberMicrobiome

Outcome Measures

Primary Outcomes (1)

  • NT-proBNP

    change in NT-proBNP level

    12 weeks

Secondary Outcomes (6)

  • Composite Clinical Outcomes

    12 weeks

  • Quality of Life

    12 weeks

  • NYHA Functional Class

    12 weeks

  • 6-Minute Walk Test

    12 weeks

  • Fecal Microbiome Characterization

    Baseline, Week 6, Week 12

  • +1 more secondary outcomes

Study Arms (3)

Microcrystalline Cellulose (MCC) 10 grams/day

ACTIVE COMPARATOR

non-fermentable active control

Dietary Supplement: Acacia Gum

Acacia Gum 5 grams/day

EXPERIMENTAL

fermentable dietary fiber

Dietary Supplement: Acacia Gum

Acacia Gum 10 grams/day

EXPERIMENTAL

fermentable dietary fiber

Dietary Supplement: Acacia Gum

Interventions

Acacia GumDIETARY_SUPPLEMENT

dietary supplement will be added to the participant's usual diet

Acacia Gum 10 grams/dayAcacia Gum 5 grams/dayMicrocrystalline Cellulose (MCC) 10 grams/day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

Location

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

Mazankowski Heart Institute

Edmonton, Alberta, T6G 2B7, Canada

Location

Related Publications (1)

  • Colin-Ramirez E, Alemayehu W, McAlister FA, Howlett JG, Willing BP, Forgie A, Madsen K, Dyck JRB, Ezekowitz JA. The Need for Fiber Addition in Symptomatic Heart Failure (FEAST-HF): A Randomized Controlled Pilot Trial. CJC Open. 2023 Jul 18;5(10):760-769. doi: 10.1016/j.cjco.2023.07.005. eCollection 2023 Oct.

    PMID: 37876886DERIVED

MeSH Terms

Conditions

Heart FailureHeart DiseasesCardiovascular Diseases

Interventions

Gum Arabic

Intervention Hierarchy (Ancestors)

Plant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesPlant ExudatesBiological ProductsComplex Mixtures

Study Officials

  • Justin Ezekowitz, MBBCh

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

January 18, 2018

First Posted

January 24, 2018

Study Start

September 13, 2018

Primary Completion

January 10, 2022

Study Completion

January 10, 2022

Last Updated

August 18, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(3)