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CompletedNCT03409926FEAST-HFUpdated Aug 18, 2022

The Need for FibEr Addition in SympTomatic Heart Failure

An interventional study of Acacia Gum in Heart Failure, sponsored by University of Alberta. Completed at 3 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-18.

Sponsored by University of Alberta · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Heart Failure

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Keywords

  • Heart Disease
  • Cardiovascular Disease
  • Diet
  • Fiber
  • Microbiome
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
51 participants (actual)

Study arms

  • Active comparator
    Microcrystalline Cellulose (MCC) 10 grams/day

    non-fermentable active control

    Dietary Supplement: Acacia Gum

  • Experimental
    Acacia Gum 5 grams/day

    fermentable dietary fiber

    Dietary Supplement: Acacia Gum

  • Experimental
    Acacia Gum 10 grams/day

    fermentable dietary fiber

    Dietary Supplement: Acacia Gum

Interventions

  • Dietary supplementAcacia Gum

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

05

What researchers measure

Primary outcomes

  1. NT-proBNP

    change in NT-proBNP level

    Time frame: 12 weeks

Secondary outcomes

  1. Composite Clinical Outcomes

    All cause death, hospitalizations and emergency department visits

    Time frame: 12 weeks

  2. Quality of Life

    Change in quality of life assessed by the Kansas City Cardiomyopathy Questionnaire

    Time frame: 12 weeks

  3. NYHA Functional Class

    Change in NYHA class treated as a categorical variable

    Time frame: 12 weeks

  4. 6-Minute Walk Test

    Change in 6-Minute Walk test

    Time frame: 12 weeks

  5. 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

    Time frame: Baseline, Week 6, Week 12

  6. ST-2

    change in ST-2 level

    Time frame: 12 weeks

06

Study locations

3 sites
  • University of Calgary
    Calgary, Alberta T2N 4Z6, Canada
  • Royal Alexandra Hospital
    Edmonton, Alberta T5H 3V9, Canada
  • Mazankowski Heart Institute
    Edmonton, Alberta T6G 2B7, Canada
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03409926
Lead sponsor
University of Alberta
Responsible party
Justin Ezekowitz (Professor of Medicine, University of Alberta) — Principal investigator
First posted
Jan 24, 2018
Start date
Sep 13, 2018
Primary completion
Jan 10, 2022
Completion
Jan 10, 2022
Last update
Aug 18, 2022

Study contacts

Justin Ezekowitz, MBBCh
principal investigator · University of Alberta

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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