None listed
Conditions
Brief summary
This study will investigate a nutritional, targeted refined supplement, to see if this product reduces inflammation in adults with IBD. We hypothesize that the targeted nutritional supplement is able to reduce inflammation in a patient population which has IBD, as well as increasing serum Vitamin D, increasing availability of omega-3 PUFA, and reducing symptoms associated with IBD.
Interventions
This study will investigate the a nutritional, targeted refined supplement, to see if this product reduces inflammation, as well as signs and symptoms in adults with IBD. This supplement is made up of Omega – 3 fish oil, (more than 500mg); vitamin D:25-OH (500IU); CoQ10 (50mg); zeaxanthin (0.82mg); ,lutein (3mg) and astaxanthin (500mcg). It also contains natural mixed tocopherols, vitamin E with ascorbyl palmitate (1mg). It will be taken orally - 2 capsules a day with the main meal. Adherence is
This study will investigate the a nutritional, targeted refined supplement, to see if this product reduces inflammation, as well as signs and symptoms in adults with IBD. This supplement is made up of Omega – 3 fish oil, (more than 500mg); vitamin D:25-OH (500IU); CoQ10 (50mg); zeaxanthin (0.82mg); ,lutein (3mg) and astaxanthin (500mcg). It also contains natural mixed tocopherols, vitamin E with ascorbyl palmitate (1mg). It will be taken orally - 2 capsules a day with the main meal. Adherence is monitored by supplement capsule return. This trial will be conducted as a controlled, double blinded, randomized, cross-over intervention trial over 18 weeks. The duration of the nutritional supplement is 6 weeks, The washout period is 6 weeks.
Sponsors
University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Have a diagnosis of Crohn's disease.
Exclusion criteria
Have had a history of cancer in the last 5 years excluding non- melanoma skin cancers. Have smoked (the equivalent of more than 10 pack years) or are smoking Have changes in medicine in the last 3 months, Have taken antibiotics in the last three months, Are on blood thinners, Are not willing to stop taking similar nutrient supplements 4 weeks before the trial begins, Would eat 4 meals or more each week of oily fish through the trial Would use a sunbed during the trial Are not willing to give Doctors name and contact details
Outcome results
None listed