None listed
Conditions
Brief summary
Ulcerative Colitis (UC) is an inflammatory bowel disease (IBD) mainly affecting the lining of the large intestine (colon) and rectum. It is a chronic, progressive condition characterised by periods of acute inflammation and remission. Symptoms may include abdominal pain, bloating, fatigue, frequency, urgency, and bloody stools. Although treatment options have improved in recent years, there exist a need for non-pharmacological options to support medical therapy and improve outcomes. Recent studies demonstrate the positive effects of extra virgin olive oil supplementation in animal models, and it is associated with prevention of the disease in Mediterrannean populations.. Separate lines of research has further demonstrated potential anti inflammatory properties of olive oil in the diet for other chronic inflammatory processes. .
Interventions
The COLONIC Study aims to investigate the impact of replacing a portion of dietary fats with extra virgin olive oil (EVOO) in the diet of community dwelling healthy subjects in comparison to those living with Ulcerative Colitis.
For both subject groups (those with UC and those without IBD), we will randomize participants into 1 of 2 diet groups; 1) total replacement of all free dietary fats with EVOO and 2) usual care, no dietary replacement. As such; participant groups would be divided into 4
The COLONIC Study aims to investigate the impact of replacing a portion of dietary fats with extra virgin olive oil (EVOO) in the diet of community dwelling healthy subjects in comparison to those living with Ulcerative Colitis. For both subject groups (those with UC and those without IBD), we will randomize participants into 1 of 2 diet groups; 1) total replacement of all free dietary fats with EVOO and 2) usual care, no dietary replacement. As such; participant groups would be divided into 4 groups: 1) Participants with UC - intervention (replace all free fats with EVOO) 2) Participants with UC - usual care 3) Participants without UC - intervention (replace all free fats with EVOO) 4) Participants without UC - usual care Free dietary fats will be defined as fats added into home made meal preparations. Examples of this includes but is not limited to cooking oil, butter, fat based spreads (e.g., margarine), and oils added into sauces and/or dressings. Fats which are an inseparable component to a food product (e.g., fat in milk, cheese, meats, nuts) will not be included in the amount calculated to be replaced. Similarly, meals not prepared at home such as restaurant foods, commercial baked goods and meals prepared by other individuals will not be included in the calculation. Calculation of the replacement will be obtained from three day weighted food diaries to be completed by all participants at baseline. The free fats from these diaries will be identified, and the research team will calculate the average daily energy contribution in kJ provided by these food items. The dose of EVOO provided for each participant on a daily basis will be based on the average daily energy contribution of their free fat intake. We will use both nutrition reference databases (AUSNUT2011-13) and EVOO manufacturer's nutrition information as a reference point for the conversion of calories contributed by EVOO into grams. The EVOO used for this study will be a commercially available product in accordance with Food Standards Australia New Zealand (FSANZ) regulations, and not a specially prepared product. Participants will be provided with the replacement EVOO by the research team for home use and will be instructed to only use the replacement oil during the intervention phase. We will aim for participant to use the replacement oil daily over a four week intervention period. All other aspects of the diet will need to be maintained during the study period. Participants will also be requested to maintain all other lifestyle factors including physical activity, intake of food supplements and any medication or therapies. In the event that any changes occur during the study period, this will be captured during a weekly follow up session over the phone. To ensure adherence during the intervention, a session with the study dietitian will be organized prior to commencement of the intervention and at 2 weeks post intervention. The session will focus on coaching, strategies to replace the free fats with the study oil, and identify practical areas where the study fat can be incorporated. Support will be provided in the form of weekly teleconferences and a fortnight face to face session. A study log will also be provided to allow for daily logging of the study oil consumption, identify areas of concern, and record any new clinical symptoms. Pre-filled and measured bottles of EVOO will also be provided to ensure accurate daily dosing during the study period. At the end of the four week intervention, participants will complete an in person assessment at the University of Sydney which will include physical assessments, collection of biospecimens (blood, stool), and completion of a 3 day weighted food diary. After completion of this mid-point assessment, all the EVOO bottles including any unused batches will be collected from the participant's household. At this point participants in the intervention group will undergo a four week washout period. Participants will be requested to resume using their preferred oil and fats for daily use as outlined in their 3 day weighted food diary at baseline. Participants will also be instructed to maintain usual intake and avoid changing their dietary patterns during this time period. The researchers will also have information of the usual diet collected at baseline prior to intervention as a general reference. Weekly teleconferences with the participants will continue during the washout period to identify any changes to behavior or medical therapy.
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
For Individuals with Ulcerative Colitis: 1) Aged >= 18 at the time of recruitment 2) Ulcerative colitis (UC) >3 months duration of any extent . 3) Willingness to participate in the study protocol, randomization and provide informed consent For non-IBD subjects: 1) Aged >= 18 years at the time of recruitment 2.) Willing to be randomized into one of the two study arms and participate in the intervention prescribed 3) Stable medication. All drugs to be held at constant dose during the study and no changes to medication in the preceding 4 weeks.
Exclusion criteria
For individuals with Ulcerative Colitis (UC) 1) Currently living with other Inflammatory Bowel Disease not defined as UC (e.g. Crohn's disease, non specific IBD) 2) History of fecal microbiota transplantation 3) Significant prior gastrointestinal surgery (e.g., colon resection, colectomy) or clinical evidence of any comorbid chronic disease that may interfere with the patient’s ability to enter the trial and undertake the testing 4) Planned major surgery within the first 3 months after randomization 5) Antibiotic/anti-tuberculosis treatment for any reason during the study period or in the preceding 4 weeks 6) Changes to UC medical therapy within 4 weeks of study initiation 7) Pregnant or female planning pregnancy for the first 3 months post randomisation 8) Diagnosed allergy or intolerance towards olives or olive based products, or avoidance of olive based products for any other reason 9) Daily consumption of olives or olive based products including spreads, oils, marinated olives, tapenade, or supplements such as olive leaf extract 10) Those undertaking a specialized diet in which the intervention would be deemed inappropriate (e;g;, fat reduction or low fat diet) or those whose diet is currently under the supervision of a relevant medical professional 11) Medical nutrition therapy under supervision of a healthcare professional (e.g., texture modifciation, progression to a full diet post hospitaliation, FODMAP or RPA elimination diet challenge phase) 12) Use of tube or enteral feeding, elemental diet, or parenteral nutrition within 4 weeks of study initiation. 13) Regular consumption of takeaway or restaurant meals more than 3 days a week or 9 meals a week.. 14) Participation in another clinical trial for with concurrent participation is deemed inappropriate. For participants in the non-IBD group: 1) History of Inflammatory Bowel Disease of any description (including remission) 2) History of fecal microbiota transplantation 3) Significant prior gastrointestinal surgery (e.g., colon resection, colectomy) or clinical evidence of any comorbid chronic disease that may interfere with the patient’s ability to enter the trial and undertake the testing 4) Planned major surgery within the first 3 months after randomization 5) Antibiotic/anti-tuberculosis treatment for any reason during the study period or in the preceding 4 weeks 6) Changes to UC medical therapy within 4 weeks of study initiation 7) Pregnant or female planning pregnancy for the first 3 months post randomisation 8) Diagnosed allergy or intolerance towards olives or olive based products, or avoidance of olive based products for any other reason 9) Daily consumption of olives or olive based products including spreads, oils, marinated olives, tapenade, or supplements such as olive leaf extract 10) Those undertaking a specialized diet in which the intervention would be deemed inappropriate (e;g;, fat reduction or low fat diet) or those whose diet is currently under the supervision of a relevant medical professional 11) Medical nutrition therapy under supervision of a healthcare professional (e.g., texture modifciation, progression to a full diet post hospitaliation, FODMAP or RPA elimination diet challenge phase) 12) Use of tube or enteral feeding, elemental diet, or parenteral nutrition within 4 weeks of study initiation. 13) Regular consumption of takeaway or restaurant meals more than 3 days a week or 9 meals a week.. 14) Participation in another clinical trial for with concurrent participation is deemed inappropriate.
Outcome results
None listed