Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000540819
Ethics application status
Approved
Date submitted
6/04/2021
Date registered
7/05/2021
Date last updated
9/12/2021
Date data sharing statement initially provided
7/05/2021
Date results information initially provided
9/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The actions of apples on gut microbiota and bowel health in healthy adults
Scientific title
The actions of apples on gut microbiota and bowel health in healthy adults: a randomised cross-over clinical trial
Secondary ID [1] 303876 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gut dysbiosis 321449 0
Condition category
Condition code
Oral and Gastrointestinal 319213 319213 0 0
Normal oral and gastrointestinal development and function
Diet and Nutrition 319214 319214 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a 17-week cross-over study, which includes three intervention periods of three weeks each, separated by 2-week wash-out periods.

During each intervention period, participants will consume a different variety of apple. Dazzle and Jazz (red apples) will be compared to Granny Smith (green apple). The red varieties have higher total concentrations of polyphenols and different polyphenol profiles from the green apple.

During each of the three intervention periods, participants will eat 2 apples per day for three weeks.

At the end of each trial period, participants will return uneaten apples to the trial coordinators as a measure of compliance. Participants will also be directly asked whether or not they adhered to the protocol.
Intervention code [1] 320180 0
Lifestyle
Intervention code [2] 320445 0
Treatment: Other
Comparator / control treatment
Our comparator is the green Granny Smith apple.

Participants will eat 2 apples per day for three weeks during their Granny Smith intervention period.
Control group
Active

Outcomes
Primary outcome [1] 327082 0
Complete Spontaneous Bowel Movement (CSBM) Frequency (CSBM/week) as a measure of overall bowel function.
Timepoint [1] 327082 0
CSBM will be measured daily using a Daily Bowel Habit Diary during the lead-in and three intervention periods.
Secondary outcome [1] 393704 0
Stool consistency as indicated by Bristol Stool Scale
Timepoint [1] 393704 0
Measured daily during the lead-in and three intervention periods
Secondary outcome [2] 393707 0
Assessment of diet as measured using a three-day Food Diary
Timepoint [2] 393707 0
At end of lead-in, end of intervention 1, end of washout 1, end of intervention 2, end of washout 2 and end of intervention 3
Secondary outcome [3] 393708 0
Gastrointestinal Symptom Rating Scale (GSRS)
Timepoint [3] 393708 0
Completed weekly by the participants during the lead-in and three intervention periods
Secondary outcome [4] 394895 0
Assessment of diet as measured using Fructan Food Frequency Questionnaire
Timepoint [4] 394895 0
At end of lead-in, end of intervention 1, end of washout 1, end of intervention 2, end of washout 2 and end of intervention 3

Eligibility
Key inclusion criteria
Healthy adults between ages of 18-65 years inclusive with a BMI between 18-35 kg/m2.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Alarm features associated with bowel habit (recent changes in bowel habit (<3 months), rectal bleeding, weight loss, occult blood in stools, anaemia), anal fissures, bleeding haemorrhoids, and family history of Gastrointestinal (GI) cancer or Inflammatory Bowel Disease (IBD).

Chronic disease (cardiovascular, cancer, renal failure, previous gastrointestinal surgery (not including appendectomy or cholecystectomy), neurological conditions (e.g. multiple sclerosis, spinal cord injury, stroke).

Fasting blood glucose greater than 6.0 mmol/l

Women who are pregnant, breastfeeding or planning a pregnancy during the study period

Allergies to apple, alder or birch pollen and latex

Screening blood test results outside of the normal range which are deemed to be clinically significant

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be enrolled by researcher after a face to face screening visit and will be given a unique identifying number (ID) for labelling all further trial data. The ID number will be provided to an independent biostatistician who will randomise the participants to the treatment schedule
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The study is designed to detect an increase of 1.0 or more CSBM per week in healthy individuals.
An initial calculation has been completed using available data. Based on previous studies, the standard deviation for the primary outcome (number of CSBM per week) is 1.41. In order to detect an increase in CSBM of 1.0 per week in the study population, with 80% power and 5% significance, 16 participants are required to complete the trial. In order to allow for an expected 25% dropout, 20 subjects will be recruited.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/05/2021
Actual
26/05/2021
Date of last participant enrolment
Anticipated
4/06/2021
Actual
14/06/2021
Date of last data collection
Anticipated
15/10/2021
Actual
3/11/2021
Sample size
Target
20
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 23582 0
New Zealand
State/province [1] 23582 0
Manawatu

Funding & Sponsors
Funding source category [1] 308270 0
Other
Name [1] 308270 0
Plant and Food Research
Country [1] 308270 0
New Zealand
Primary sponsor type
Other
Name
Plant and Food Research
Address
Batchelar Road
Fitzherbert
Palmerston North
4410
Country
New Zealand
Secondary sponsor category [1] 309066 0
None
Name [1] 309066 0
Address [1] 309066 0
Country [1] 309066 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308246 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 308246 0
133 Molesworth Street
Thorndon
Wellington 6011

Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 308246 0
New Zealand
Date submitted for ethics approval [1] 308246 0
16/04/2021
Approval date [1] 308246 0
18/05/2021
Ethics approval number [1] 308246 0
21/NTB/106

Summary
Brief summary
We hypothesise that undigested bioactive components of apples (fibre and polyphenols) can improve gastrointestinal health by enhancing the elimination of waste, the gut environment, and structure and function of the microbiome.

The proposed study will be a randomised, controlled, cross-over clinical intervention study. The cross-over design will be completed using three interventions of two apples per day. There will be three different varieties (Granny Smith, Jazz and Dazzle) of commercially available apples.

The study duration is a total of 17 weeks; 2-week lead in, 3-week intervention. 2-week washout, 3-week intervention, 2-week washout, 3-week intervention and final 2-week follow-up.

The primary outcome measure will be quantification of CSBM (complete spontaneous bowel movement). Secondary outcome measures will include Daily Bowel Habit Diary, Three-day Food Diary, Fructan Food Frequency Questionnaire and Gastrointestinal Symptom Rating Scale.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110058 0
Dr Christine Butts
Address 110058 0
Plant and Food Research
Batchelar Road
Fitzherbert
Palmerston North
4410
Country 110058 0
New Zealand
Phone 110058 0
+64 6 3556147
Fax 110058 0
Email 110058 0
[email protected]
Contact person for public queries
Name 110059 0
Mrs Hannah Dinnan
Address 110059 0
Plant and Food Research
Batchelar Road
Fitzherbert
Palmerston North
4410
Country 110059 0
New Zealand
Phone 110059 0
+64 6 353 0962
Fax 110059 0
Email 110059 0
[email protected]
Contact person for scientific queries
Name 110060 0
Dr Christine Butts
Address 110060 0
Plant and Food Research
Batchelar Road
Fitzherbert
Palmerston North
4410
Country 110060 0
New Zealand
Phone 110060 0
+64 6 3556147
Fax 110060 0
Email 110060 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
All participant information collected in all parts of the study is confidential and will not be available to anyone other than the PI, the study co-ordinator and the collaborators.


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.