None listed
Conditions
Brief summary
Irritable bowel syndrome (IBS) is a very common condition that has a big impact on quality of life. IBS and common mental health disorders (like anxiety and depression) are strongly linked. In fact, more than 30% of people with IBS also have anxiety and more than 20% have depression. Changing diet can be very helpful for improving IBS symptoms but some specific diets can be difficult to follow. An alternative dietary approach, which will be investigated in this study, has been found to improve depressive symptoms. The diet may also have positive affects for the gut microbiome (the micro-organisms found in the gut), which is also important in IBS, and for other health outcomes. This study aims to test if this diet can be followed and is acceptable for people with IBS and current symptoms of anxiety or depression. It also aims to understand whether this diet could improve gut as well as mental health symptoms, and how it might do this. The results of this study may contribute to the clinical management of people with IBS and mental health problems.
Interventions
The study aims to recruit 60 individuals with IBS and current anxiety or depressive symptoms aged between 18 and 65 years. This study will be conducted via online Zoom videoconferencing and telephone. There will be no in-person appointments. All screening, study visits and dietary advice will be implemented by the study dietitians (gastrointestinal specialists; 2 and 18 years' experience).
After screening and consent, participants will complete a short online questionnaire about gastrointestina
The study aims to recruit 60 individuals with IBS and current anxiety or depressive symptoms aged between 18 and 65 years. This study will be conducted via online Zoom videoconferencing and telephone. There will be no in-person appointments. All screening, study visits and dietary advice will be implemented by the study dietitians (gastrointestinal specialists; 2 and 18 years' experience). After screening and consent, participants will complete a short online questionnaire about gastrointestinal symptoms daily for seven days and an online food diary daily for 3 days, both prior to allocation to the intervention or control group. Before the first study visit, a stool sample collection kit will be provided for participants to collect a stool sample in their home. First study visit: The first study visit (baseline) will be conducted on Zoom for approximately 60 minutes. During this visit, demographic details and medical history will be collected, and participants will complete online questionnaires about psychological symptoms, gastrointestinal symptoms, and diet. Participants will then be randomly allocated to one of two groups for six weeks: 1. Intervention group – participants receive Mediterranean dietary advice, or; 2. Control group – participants continue regular diet Those randomised to the intervention group will receive Mediterranean dietary advice, including information about food group targets, practical shopping advice, and written resources such as recipes. These resources have been designed specifically for this study. A food hamper will be provided via supermarket delivery in the first week of the intervention to facilitate adherence. The diet will be personalised, depending on food preferences and gastrointestinal (GI) symptoms. Weekly contact: Participants in the intervention and control group will be contacted weekly (by Zoom videoconferencing or telephone) to ask about their current health, medications and adverse events. This is also an opportunity for those in the intervention group to ask questions about the diet. For individuals in the intervention group, weekly goal setting activities will facilitate dietary adherence. The duration of these phone calls will be approximately 10 minutes. Final study visit: The final visit will take place in week 6 on Zoom for approximately 60 minutes. Participants will repeat the questionnaires completed at the first study visit. If participants are in the intervention group, they will also complete one additional questionnaire about their diet. In preparation for the final study visit, participants will complete a short online questionnaire about gastrointestinal symptoms daily for seven days. An online food diary will also be completed daily for 3 days. A second stool sample collection kit will be provided for participants to collect a stool sample in their home. Dietary adherence (for both intervention and control group) will be assessed via the 3-day online food diary and the dietary questionnaire completed at the final study visit.
Sponsors
Deakin University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Inclusion criteria • Aged 18-65 years • IBS diagnosis (Rome IV criteria) of any IBS subtype (diarrhea-predominant, constipation-predominant, mixed, un-subtyped) • Hospital anxiety and depression score (HADS) subscale score of 8-14, indicating mild or moderately severe anxiety or depressive symptoms •Access to computer and internet access
Exclusion criteria
• Known or suspected major medical conditions • Females who report to be pregnant or lactating • Unable to follow Mediterranean diet study recommendations (e.g. veganism, lacto-ovo vegetarians, inability to follow for sociocultural or religious reasons) • Co-existing eating disorder or highly disordered eating • Underweight (BMI <18.5 kg/m2) or obesity (>40 kg/m2) • Change in IBS or anxiety/depression medication or exposure to pre- or probiotic supplements in the last month or antibiotics or bowel preparation for investigative procedures within the past three months
Outcome results
None listed