Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000092998
Ethics application status
Approved
Date submitted
23/12/2019
Date registered
3/02/2020
Date last updated
3/02/2020
Date data sharing statement initially provided
3/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Broth & Co Beef Bone Broth on lower gastrointestinal disturbances: The Bone Broth Gut Study
Scientific title
Single-arm pre-post study of 12 weeks duration investigating the effect of the Broth & Co Bone Broth powder on gastrointestinal disturbances in adults
Secondary ID [1] 300030 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
lower gastrointestinal tract disorders 315533 0
inflammatory bowel disease 315971 0
Condition category
Condition code
Oral and Gastrointestinal 313816 313816 0 0
Inflammatory bowel disease
Oral and Gastrointestinal 313817 313817 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single-arm pre-post study of 12 weeks duration investigating the effect of the Broth & Co Bone Broth Powder on lower gastrointestinal disorders in adults. After a run-phase of 4 weeks serving as control phase, the intervention will comprise of 2 x 5g Bone Broth powder (2x 1 tsp from 100g pouch) mixed in 100-150 ml of warm water per day for 8 weeks. Participants will be supplied with 2x4 weeks of Bone Broth Powder for consumption.
The commercially available Broth & Co Bone Broth freeze-dried powder is made from Australian grass fed and free range beef bone and connective tissue containing a nutrient rich mix of amino acids, minerals, collagen/gelatin and glucosamine/chondroitin.
Compliance will be monitored by return of remaining investigational product at the end of the study.
Intervention code [1] 316425 0
Treatment: Other
Comparator / control treatment
Run-in phase of 4 weeks with no intervention will serve as a control phase. Participants are advised to keep to their usual diet and exercise routine during the study, including the run-in phase. Participants are to note any non-routine activities/diet, and to report this at their next appointment.
Control group
Active

Outcomes
Primary outcome [1] 322388 0
Symptoms relief, including constipation, diarrhea, bloating, pain, reflux
measured by questionnaires
Questionnaires: Birmingham IBS Symptom Q, Bristol Stool Chart, Leeds Dyspepsia Q, Tolerability, other symptoms Q
Each validated questionnaire consists of multiple questions re multiple symptoms. Relief of the sum of all symptoms will provide the composite outcome measure studied.
Timepoint [1] 322388 0
Start of run-in phase (-4 weeks), Baseline, (0 weeks), 4 weeks and 8 weeks post-intervention commencement
Primary outcome [2] 322389 0
Quality of Life
assessed by questionnaires:
IBS-QoL, GERD-QoL, GERD-Health related QoL
Timepoint [2] 322389 0
Start of run-in phase (-4 weeks), Baseline, (0 weeks), 4 weeks and 8 weeks post-intervention commencement, etc.
Primary outcome [3] 322390 0
Intestinal permeability/ leaky gut: by urine test kit
Lactulose/Mannitol ratio
Timepoint [3] 322390 0
Baseline (0 weeks) and 8 weeks post-intervention commencement
Secondary outcome [1] 378295 0
Pain
by VAS 10-point Likert scale
Timepoint [1] 378295 0
Start of run-in phase (-4 weeks), Baseline, (0 weeks), 4 weeks and 8 weeks post-intervention commencement
Secondary outcome [2] 378296 0
Food Trigger questionnaire
Timepoint [2] 378296 0
Start of run-in phase (-4 weeks), Baseline, (0 weeks) and 8 weeks post-intervention commencement

Eligibility
Key inclusion criteria
Adults with moderate lower gastrointestinal disturbances
including constipation, diarrhea, bloating, troublesome flatulence, abdominal pain
Participants may experience one or multiple symptoms at least once a week for at least 3 months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Gastrointestinal disturbances due to other causes, e.g. pregnancy, cancer
If applicable, has been on medication for at least 2 months
Planned surgery, medication change in the net 3-4 months/during the study
Intolerance or allergy to any of the ingredients in the Beef Bone Broth

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
No allocation concealment. Run-in phase with no intervention will serve as control phase.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
pre-post study design: 4 week run-in phase will serve as control
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 30 patients was calculated based on the following assumptions:
a) To detect a difference of 0.78% (SD=0.1) in Lactulose levels (Leaky gut test: Lactulose/Mannitol change detected in Gut Relief Study)submitted before and after the active treatment with >90% power and 95% confidence;
b) to account for 20% drop-out or non-attendance at all appointments.

Analysis
Analyses will be performed using SPSS (PASW version 18). Statistical significance will be set at p<0.05. This is a pilot study and differences within the group (pre- and post-intervention) will be analysed with repeated measures ANOVA at 8 and 12 weeks compared to baseline at 4 weeks. The first 3-4 weeks will serve as run-in control phase for comparative analysis of weeks 0 and 4 for questionnaires. Leaky gut analysis at 12 weeks will be compared to baseline (0-4 weeks).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2020
Actual
Date of last participant enrolment
Anticipated
30/06/2020
Actual
Date of last data collection
Anticipated
30/09/2020
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 28925 0
3121 - Burnley
Recruitment postcode(s) [2] 28926 0
3122 - Hawthorn
Recruitment postcode(s) [3] 28927 0
3123 - Auburn

Funding & Sponsors
Funding source category [1] 304485 0
Commercial sector/Industry
Name [1] 304485 0
Broth & Co
Country [1] 304485 0
Australia
Primary sponsor type
Individual
Name
AProf Dr Karin Ried
Address
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn, VIC 3122
Country
Australia
Secondary sponsor category [1] 304752 0
None
Name [1] 304752 0
Address [1] 304752 0
Country [1] 304752 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304917 0
National Institute of Integrative Medicine Human Research Ethics Committee
Ethics committee address [1] 304917 0
Ethics committee country [1] 304917 0
Australia
Date submitted for ethics approval [1] 304917 0
01/11/2019
Approval date [1] 304917 0
23/12/2019
Ethics approval number [1] 304917 0
0059N_2019

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98634 0
A/Prof Karin Ried
Address 98634 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn VIC 3122
Country 98634 0
Australia
Phone 98634 0
+61 03 9912 9545
Fax 98634 0
Email 98634 0
[email protected]
Contact person for public queries
Name 98635 0
Karin Ried
Address 98635 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn VIC 3122
Country 98635 0
Australia
Phone 98635 0
+61 03 9912 9545
Fax 98635 0
Email 98635 0
[email protected]
Contact person for scientific queries
Name 98636 0
Karin Ried
Address 98636 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn VIC 3122
Country 98636 0
Australia
Phone 98636 0
+61 03 9912 9545
Fax 98636 0
Email 98636 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No individual data will be divulged to respect privacy of participants, however summary of de-identified data will be shared in peer-reviewed publications and conferences.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.