Heart FailureFEAST-HFNCT03409926
The Need for FibEr Addition in SympTomatic Heart Failure
A study testing Acacia Gum in people with Heart Failure, run by University of Alberta at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Acacia Gum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 3 sitesCanada
- Study dates
- 13 Sep 2018to 10 Jan 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
University of Calgary
Calgary, Alberta, T2N 4Z6
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9
Mazankowski Heart Institute
Edmonton, Alberta, T6G 2B7
About this study
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.
- Conditions
- Heart Failure
- Being tested
- Acacia Gum
- Keywords
- Heart Disease, Cardiovascular Disease, Diet, Fiber, Microbiome
- Medical subject headings
- Heart Failure, Heart Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acacia GumDietary supplement
dietary supplement will be added to the participant's usual diet
| Study group | Role | What they receive |
|---|---|---|
| Microcrystalline Cellulose (MCC) 10 grams/day | Active comparator | non-fermentable active control Receives: Dietary Supplement: Acacia Gum |
| Acacia Gum 5 grams/day | Experimental | fermentable dietary fiber Receives: Dietary Supplement: Acacia Gum |
| Acacia Gum 10 grams/day | Experimental | fermentable dietary fiber Receives: Dietary Supplement: Acacia Gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
NT-proBNP
change in NT-proBNP level
Measured: 12 weeks
Secondary outcomes (6)
Composite Clinical Outcomes
All cause death, hospitalizations and emergency department visits
Measured: 12 weeks
Quality of Life
Change in quality of life assessed by the Kansas City Cardiomyopathy Questionnaire
Measured: 12 weeks
NYHA Functional Class
Change in NYHA class treated as a categorical variable
Measured: 12 weeks
6-Minute Walk Test
Change in 6-Minute Walk test
Measured: 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
Measured: Baseline, Week 6, Week 12
ST-2
change in ST-2 level
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start13 Sep 2018
- Primary completion10 Jan 2022
- Study completion10 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justin Ezekowitz, University of Alberta
- Investigators
- Justin Ezekowitz, MBBCh, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03409926
- Sponsor's protocol ID
- Pro00078692
- Acronym
- FEAST-HF
- Status last verified
- Aug 2022
- First submitted
- 18 Jan 2018
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37876886
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Need for FibEr Addition in SympTomatic Heart Failure
- ClinicalTrials.gov ID
- NCT03409926
- Acronym / sponsor ID
- FEAST-HF / Pro00078692
- Conditions
- Heart Failure
- Keywords
- Heart Disease, Cardiovascular Disease, Diet, Fiber, Microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 13 Sep 2018 (actual)
- Primary completion
- 10 Jan 2022 (actual)
- Study completion
- 10 Jan 2022 (actual)
- First posted
- 24 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Microcrystalline Cellulose (MCC) 10 grams/day | Active comparator | Dietary Supplement: Acacia Gumnon-fermentable active control |
| Acacia Gum 5 grams/day | Experimental | Dietary Supplement: Acacia Gumfermentable dietary fiber |
| Acacia Gum 10 grams/day | Experimental | Dietary Supplement: Acacia Gumfermentable dietary fiber |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acacia Gumdietary supplement will be added to the participant's usual diet | Dietary supplement | Acacia Gum 10 grams/day, Acacia Gum 5 grams/day, Microcrystalline Cellulose (MCC) 10 grams/day |
Primary outcome
NT-proBNP
Time frame: 12 weeks
change in NT-proBNP level
6 secondary outcomes
Composite Clinical Outcomes
Time frame: 12 weeks
Quality of Life
Time frame: 12 weeks
NYHA Functional Class
Time frame: 12 weeks
6-Minute Walk Test
Time frame: 12 weeks
Fecal Microbiome Characterization
Time frame: Baseline, Week 6, Week 12
ST-2
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Derived from this study: PubMed 37876886Colin-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin Ezekowitz, MBBCh principal investigator
University of Alberta
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acacia Gum in people with Heart Failure, run by University of Alberta at 3 sites in Canada.
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 3 inclusion and 3 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 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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?
NT-proBNP (time frame: 12 weeks). 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 NCT03409926, which also lists 1 linked publication.
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 18 Aug 2022.