None listed
Conditions
Brief summary
There is substantial anecdotal evidence from people with rheumatoid arthritis (RA) that following the autoimmune protocol (AIP) diet, an extension of the paleolithic diet, is associated with alleviation of symptoms, especially pain and fatigue. To date, this diet has not been clinically tested with this group. A pilot AIP intervention and feasibility study was carried out in people with RA. Nine volunteer participants with clinically validated RA completed the 12-week study. They ate their usual diet for 4 weeks, then were given instruction and support from a registered nutritionist to follow the AIP diet for 8 weeks. Assessments included its effect, using validated patient reported outcome questionnaires on quality of life, fatigue, pain, sleep and emotional wellbeing. Biometric measures were taken to assess weight, waist and BMI changes. At the conclusion of the study a semi-structured interview was conducted of to gain insight into participants' experience on the diet. Feasibility measures included adherence, cost, and ease of implementing the diet. Three-day dietary records taken in both the control and AIP phases are being analysed for changes in intakes of macro and micronutrients and nutrient adequacy. A one year follow up assessed to what extent the diet was being maintained. All repeat measures were taken including PRO questionnaires to assess RA activity, and these will be compared to baseline and study end measures. A qualitative interview was conducted with each participant to explore their experiences since the end of the intervention.
Interventions
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.
Sponsors
Study design
Eligibility
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.
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.