None listed
Conditions
Brief summary
Inflammation and disturbances in the gut microbiota (dysbiosis) are hallmarks of a disease affecting the intestine known as Inflammatory Bowel Disease (IBD). IBD is broadly classified into two main subtypes based on the regions of the intestine affected: Crohn’s disease (CD) and Ulcerative colitis (UC). Both subtypes of IBD are likely to be influenced by diet, however, most studies on dietary supplementation show benefit in UC. Apples are an excellent example of a commonly consumed low-cost fruit grown in NZ and globally that could have potential benefits in IBD. Animal studies show that apple extracts can reduce pathological parameters of the disease. In this study, we will be using an apple product created from a heritage apple variety known as Monty's surprise, that has higher phytochemical concentrations compared to commercial apple varieties. We will be conducting a pilot intervention study with UC participants. Aims: - To assess changes in gut inflammation - To assess changes in disease activity and quality of life - To assess changes in the gut microbiota and short chain fatty acid production - To assess whether the participant's genetic profile influences their response to treatment (personalized nutrition)
Interventions
This is an intervention study conducted to assess the effects of apple on gastrointestinal symptoms and disease activity in patients with ulcerative colitis. Eligible participants will be monitored for disease activity and symptoms for 6-weeks. Additionally, for 2-weeks starting from week 3 of the study, An experienced nutrition researcher will ask the participants to consume a ~250g apple study product provided, daily.
The apple study product will be stored in ~250g amounts, pre-prepared in Ma
This is an intervention study conducted to assess the effects of apple on gastrointestinal symptoms and disease activity in patients with ulcerative colitis. Eligible participants will be monitored for disease activity and symptoms for 6-weeks. Additionally, for 2-weeks starting from week 3 of the study, An experienced nutrition researcher will ask the participants to consume a ~250g apple study product provided, daily. The apple study product will be stored in ~250g amounts, pre-prepared in Massey University's product development lab or pilot plant, under strict hygiene conditions and released for consumption. At the beginning of week 3 and Week 4, participants will be given 1-week supply of the study product to store in their freezers and consume the content of one product pack per day. Participants will complete 24-hour recall diaries daily and return all study product packaging to the research unit to assess adherence. Weekly: Participants will be asked to complete online questionnaires through a secure data management platform (RedCAP) and fecal samples will be collected.
Sponsors
Noha Nasef
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
17 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
• Established diagnosis of UC for at least 6-months • Faecal calprotectin of greater than 200 µg/g • male or female aged between 18 and 60 • Ability to complete web-based questionnaires in English • Must have an email address and access to a computer and internet. Must have time to complete online weekly questionnaires (~30 minutes each).
Exclusion criteria
• Those who are in remission (P-SCCAI score less than or equal to 2) and disease inactive (MIBDI score) • Those with severe disease activity • History of colectomy, total colectomy or colostomy • Probiotic use • Pregnant or breast feeding • Known allergies or hypersensitivity to apples. • Any significant comorbidities • Antibiotic therapy in the last 4 weeks prior to inclusion into the study
Outcome results
None listed