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Trial registered on ANZCTR


Registration number
ACTRN12624001391561
Ethics application status
Approved
Date submitted
4/11/2024
Date registered
25/11/2024
Date last updated
25/11/2024
Date data sharing statement initially provided
25/11/2024
Date results provided
25/11/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot study to assess the effect of the auto-immune protocol (AIP) diet in people with rheumatoid arthritis, with a one year follow-up.
Scientific title
A pilot feasibility, mixed methods, single arm, two-phase, open-label dietary intervention study to test the effect of the autoimmune protocol (AIP) diet in people with rheumatoid arthritis. A one-year mixed methods follow-up of all participants.
Secondary ID [1] 313292 0
Nil
Universal Trial Number (UTN)
U1111-1261-8728
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid arthritis 335638 0
Condition category
Condition code
Inflammatory and Immune System 332195 332195 0 0
Rheumatoid arthritis
Diet and Nutrition 332314 332314 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After a 4-week phase where participants consume their usual diet, they are given instructions on how to follow the autoimmune protocol (AIP) diet which they adhere to for an 8-week intervention phase.
The AIP diet is a version of the paleolithic diet originally described by Professor Loren Cordain, which is theorised to help people with auto immune disease by excluding foods which act increase gut inflammation or act as antigens. It excludes all grains and pseudo grains, legumes, dairy, nightshade vegetables and fruit, seeds, nuts, eggs, alcohol, food additives (e.g. synthetic colours, flavours, emulsifiers, and preservatives), and processed foods containing additives. Allowed foods included all unprocessed meat, poultry, seafood, all vegetables and fruit (except nightshades), and fats such as avocado, olive, coconut oils, and animal fats. Participants source and prepare all their own meals and eat ad libitum.
At the end of the control phase each person meets with the researcher, a New Zealand registered nutritionist for a 1-hour meeting, either in person at AUT Albany or over a video call in the event of a pandemic lockdown. Participants receive verbal instructions, as well as a detailed instruction booklet with information on how to follow the AIP diet. All participants are given the same information, there is no dietary individualisation. The booklet includes lists of foods to avoid and eat, meal and snack ideas, recipes, and shopping resources. The material was developed specifically for this trial, for New Zealand based participants, using the resources from the AIP coach training programme and the book "The Paleo Approach" by Sarah Ballantyne PhD. The instructional session is in person at AUT Millennium or via a video call.
Ongoing support is provided by the registered nutritionist, via email or phone. Participants are able to contact the researcher at any time during the the intervention if they have questions regarding the implementation of the diet. An optional, researcher moderated, private Facebook group is created for additional guidance, shared recipes, resources and Q&A. A 30-minute support video or in person meeting is carried out at week 8, halfway through the intervention phase with each participant.
In person meetings are at AUT Millennium, Albany Auckland, NZ, In the event of pandemic lockdown all meetings are shifted online to zoom video calls.
Adherence is monitored, each person fills in a daily checklist and documents any food they consume that is on the excluded list. Completed lists are returned weekly to the researcher via email.

After the 8-week intervention participants are given verbal and written instructions to reintroduce excluded foods and monitor the effect, however participants are free to consume any diet without restriction.

In the one-year post diet study investigation, participants are invited to complete a one-off set of repeat measures, without any further dietary intervention. They fill in the online PRO questionnaires which take approximately 5 minutes. They complete a 3-day diet record on the phone app 'Easy diet diary'. They fill in a 7-day checklist of the number of portions of foods they currently consume that were excluded during the intervention, in a table in a word document ( a few minutes each day), They take their own weight and measure waist circumference. They each take part in a semi-structured interview for approximately 30-45 minutes. All these are conducted over the course of one week.
Intervention code [1] 329871 0
Lifestyle
Intervention code [2] 329968 0
Treatment: Other
Comparator / control treatment
The first 4 weeks the participants consume their usual diet, followed by an eight week intervention where participants follow the autoimmune protocol diet.
Control group
Active

Outcomes
Primary outcome [1] 339779 0
Assessment of rheumatoid arthritis (RA) disease activity.
Assessment method [1] 339779 0
Patient reported outcome (PRO) questionnaire Rapid3, (Routine Assessment of Patient Index Data 3). This is completed online via Question Pro platform
Timepoint [1] 339779 0
Baseline and weekly, week 1,2,3,4,5,6,7,8,9,10,11,12. Control 4 weeks (mean of baseline and week 1,2,3, 4) is compared to week 12 (primary timepoint). The questionnaire is repeated once 1 year post study and compared to control and week 12 intervention.
Primary outcome [2] 339780 0
An assessment of domains of the highest importance to RA patients (pain, function, fatigue, sleep disturbance, emotional well-being, physical well-being and coping). This is a composite outcome, with one measure from 0 to 10.
Assessment method [2] 339780 0
PRO questionnaire RAID (Rheumatoid Arthritis Impact of Disease) developed by the European League Against Rheumatism (EULAR) completed online via QuestionPro platform.
Timepoint [2] 339780 0
Baseline and weekly, week 1,2,3,4,5,6,7,8,9,10,11,12. Control 4 weeks (mean of baseline and week 1,2,3, 4) compared to week 12 (primary timepoint). The questionnaire is repeated once 1 year post study and compared to control and week 12 intervention.
Secondary outcome [1] 441274 0
Participant requirement for discretionary pain relief.
Assessment method [1] 441274 0
Daily documenting discretionary pain or anti-inflammatory medication used, Filled in on a word document daily and submitted to researcher at the end of each week
Timepoint [1] 441274 0
Baseline and weekly, week 1,2,3,4,5,6,7,8,9,10,11,12. Control 4 weeks (baseline and week 1,2,3, 4) compared to week 12 . Documented again for 1 week, 1 year post study end.
Secondary outcome [2] 441275 0
Nutrition analysis of baseline and AIP diet, and one year post study diet, to assess for nutrient adequacy and changes in diet and nutrient intakes. This will be assessed as a composite outcome.
Assessment method [2] 441275 0
3-day diet records, three consecutive days; two workdays, and one weekend or non-work day, using the phone app “Easy Diet Dairy” (Xyris Software). Participants photographed all meals and snacks using either Easy Diet Diary or “See What You Eat” (Health Revolution Ltd.) phone app, to allow for cross-checking of dietary records. Photographed meals are not assessed, they are used solely to check that the diary is recorded accurately.
Timepoint [2] 441275 0
Baseline and week 4 of control period, and weeks 8 and 12 of the AIP phase. Control phase compared to AIP phase. The 3-day diary is also completed once at 1 year post study end, to be compared to diet study usual diet and AIP phase.
Secondary outcome [3] 441276 0
Participant experience on the difficulty or ease of implementing AIP compared to participant's usual diet
Assessment method [3] 441276 0
A 5-point Likert scale is completed each week via the online questionnaire, the scale ranges from much more difficult to much easier when AIP is compared to usual diet
Timepoint [3] 441276 0
Post commencement of the AIP phase, weeks 5,6,7,8,9,10,11,12.
Secondary outcome [4] 441277 0
The cost of implementing AIP compared to participant's usual diet
Assessment method [4] 441277 0
5-point Likert scale and reported each week via the online questionnaire, the cost (money spent) for AIP compared to usual diet, ranging from much more expensive to much cheaper.
Timepoint [4] 441277 0
Post commencement of the AIP phase, weeks 5,6,7,8,9,10,11,12.
Secondary outcome [5] 441278 0
The effect of the diet on body weight, BMI and body composition.
Assessment method [5] 441278 0
Body composition and weight is measured using Tanita bioelectrical impedance analysis (BIA) scales, In the event of Covid lockdown this is changed to participant using own home scales, in light clothes at the same time of day.
Timepoint [5] 441278 0
Baseline and week 4 of control period, and weeks 8 and 12 (primary endpoint) of the AIP phase. Also repeated at 1 year post study end and compared to both timepoints in study.
Secondary outcome [6] 441279 0
The effect of the diet on waist circumference
Assessment method [6] 441279 0
Waist circumference is measured at the naval level, with tape measure level on bare skin or light clothes, at the same time of day each time. In the event of Covid lockdown this is changed to participant self-measure at home.
Timepoint [6] 441279 0
Baseline and week 4 of control period, and weeks 8 and 12 (primary endpoint) of the AIP phase. Also repeated at 1 year post study end.
Secondary outcome [7] 441280 0
The effect of AIP diet on grip strength
Assessment method [7] 441280 0
Bilateral grip strength assessment (using a dynamometer).
Timepoint [7] 441280 0
Baseline and week 4 of control period, and weeks 8 and 12 of the AIP phase. One year post study.
Secondary outcome [8] 441281 0
The participant experience of the AIP diet and being in a clinical study, in order to enrich and explain study findings
Assessment method [8] 441281 0
Qualitative individual semi-structured interviews approximately 45-60 minutes long, video and audio recorded via zoom platform. The study uses an explanatory sequential mixed methods design. The interviews will be analysed using inductive, then abductive thematic analysis in a qualitative descriptive approach.
Timepoint [8] 441281 0
At the end of the AIP intervention, i.e. after week 12, and again 1 year post study end.
Secondary outcome [9] 441282 0
Participant adherence to AIP diet.
Assessment method [9] 441282 0
A weekly checklist, where any foods eaten that are excluded on AIP are documented daily, and the checklist is sent to researcher at the end of each week.
Timepoint [9] 441282 0
Post commencement of the AIP phase, weeks 5,6,7,8,9,10,11,12.
Secondary outcome [10] 441283 0
Foods eaten one year post study that were restricted on AIP
Assessment method [10] 441283 0
A one-week checklist, filled in daily with the portion numbers of foods currently eaten that were restricted on the AIP diet intervention.
Timepoint [10] 441283 0
Approximately one year from the end of AIP intervention
Secondary outcome [11] 441284 0
Adverse effects of diet observed by participants
Assessment method [11] 441284 0
A weekly open-ended question in the online questionnaire asking, "Have you noticed any negative effects related to diet in the last 7 days?"
Timepoint [11] 441284 0
Weekly: End week 1,2,3,4 (control phase), End week 5,6,7,8,9,10,11,12 (AIP phase)
Secondary outcome [12] 441285 0
Participant observations of any positive effects related to diet.
Assessment method [12] 441285 0
A weekly open-ended question in the online questionnaire asking "Have you noticed any positive effects related to diet in the last 7 days?"
Timepoint [12] 441285 0
Weekly: End week 1,2,3,4 (control phase), End week 5,6,7,8,9,10,11,12 (AIP phase)
Secondary outcome [13] 441286 0
The effect of diet on blood pressure
Assessment method [13] 441286 0
Blood pressure is taken in person with Omron automatic blood pressure monitor
Timepoint [13] 441286 0
Baseline, and weeks 4 (control phase), week 8 and 12 (AIP phase). One year post study.

Eligibility
Key inclusion criteria
Inclusion criteria are individuals aged 18 years or over, with clinically confirmed RA of a duration of 6 months or more, on stable medication, including supplements, of > 8 weeks. Participants are conversant in English, have access to a computer and smart phone, are computer literate, able to drive or come to 4-in person appointments at AUT Albany, and able to commit to the study for 12 weeks.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria included being pregnant, having diagnosed health conditions such as diabetes mellitus, renal impairment, or liver disease. Being on a diet that restricts any food group. Have changed medication dose or type in the last 8 weeks, or had started using or stopped supplements that mediate inflammation in the previous 8 weeks.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Due to a small sample size and being a pilot study, quantitative data is presented as individual responses.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
25/06/2021
Date of last participant enrolment
Anticipated
Actual
12/08/2021
Date of last data collection
Anticipated
Actual
5/12/2022
Sample size
Target
10
Accrual to date
Final
9
Recruitment outside Australia
Country [1] 26669 0
New Zealand
State/province [1] 26669 0
Auckland

Funding & Sponsors
Funding source category [1] 317743 0
University
Name [1] 317743 0
Auckland University of Technology AUT (PhD fund)
Country [1] 317743 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology AUT
Country
New Zealand
Secondary sponsor category [1] 320068 0
None
Name [1] 320068 0
Country [1] 320068 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316430 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 316430 0
Ethics committee country [1] 316430 0
New Zealand
Date submitted for ethics approval [1] 316430 0
26/02/2021
Approval date [1] 316430 0
03/05/2021
Ethics approval number [1] 316430 0
21/NTB/55 and 2022 AM 10311 (for 1 year follow-up amendment, 30 August 2022)
Ethics committee name [2] 316437 0
Auckland University of Technology Ethics Committee
Ethics committee address [2] 316437 0
Ethics committee country [2] 316437 0
New Zealand
Date submitted for ethics approval [2] 316437 0
26/05/2021
Approval date [2] 316437 0
31/05/2021
Ethics approval number [2] 316437 0
21/168

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 137870 0
Mrs Julianne McNeill
Address 137870 0
School of Sport & Recreation. Human Potential Centre, Faculty of Health and Environmental Sciences, Auckland University of Technology, Auckland 0632
Country 137870 0
New Zealand
Phone 137870 0
+64 21 680703
Email 137870 0
jultay90@autuni.ac.nz
Contact person for public queries
Name 137871 0
Julianne McNeill
Address 137871 0
School of Sport & Recreation. Human Potential Centre, Faculty of Health and Environmental Sciences, Auckland University of Technology, Auckland 0632,
Country 137871 0
New Zealand
Phone 137871 0
+64 21 680703
Email 137871 0
jultay90@autuni.ac.nz
Contact person for scientific queries
Name 137872 0
Julianne McNeill
Address 137872 0
School of Sport & Recreation. Human Potential Centre, Faculty of Health and Environmental Sciences, Auckland University of Technology, Auckland 0632
Country 137872 0
New Zealand
Phone 137872 0
+64 21 680703
Email 137872 0
jultay90@autuni.ac.nz

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers that contact the primary researcher / author after publication, requesting raw data will be granted access in a case-by-case basis at the discretion of the primary researcher.

Conditions for requesting access:
• -

What individual participant data might be shared?
• All individual data collected, de-identified

What types of analyses could be done with individual participant data?
• Researchers requesting data will need to specify how they intend to use it. The primary researchers will evaluate the request to ensure the proposed use aligns with the data’s scope and any ethical considerations.

When can requests for individual participant data be made (start and end dates)?
From:
Following publication. No end date.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• If approved, data will be provided from the primary research / author. Primary researcher Julianne McNeill, email: jultay90@autuni.ac.nz


Are there extra considerations when requesting access to individual participant data?
No


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.