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Traditional Dietary Advice Vs. Mediterranean Diet in IBS

Primary Purpose

Irritable Bowel Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Traditional Diet
Mediterranean Diet
Sponsored by
Sheffield Teaching Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: IBS Symptom Severity Scale(IBS-SSS) > 75 Online access English literate Exclusion Criteria: Organic gastrointestinal diseases (e.g. inflammatory bowel disease, GI cancer, coeliac disease, microscopic colitis, bile acid diarrhoea) Major abdominal surgery (except laparoscopy, appendectomy, cholecystectomy) History of eating disorder Body mass index <20 Current dietary interventions Current use of opioids/antibiotics Titrating dose of neuromodulators Severe systemic disease (e.g. cardiac, renal, respiratory, psychiatric) necessitating frequent medical consultations/hospitilisations Pregnant Diabetes mellitus Scleroderma Memory impairment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Traditional Dietary Advice

    Mediterranean Diet

    Arm Description

    Its main elements are to adopt sensible eating habits and avoid excess fatty foods, spicy foods, processed foods, caffeine, fizzy drinks and alcohol.

    The principle components is a diet rich in vegetables, pulses, whole grains, and olive oil

    Outcomes

    Primary Outcome Measures

    Proportion of IBS patients experiencing clinical response with traditional dietary advice vs. Mediterranean diet
    IBS symptom severity scale (IBS-SSS) where a 50-point reduction denotes a meaningful clinical response

    Secondary Outcome Measures

    Changes in individual items of the IBS-SSS
    IBS- SSS contains 5 specific questions (pain severity, pain frequency, abdominal distension severity, bowel movement satisfaction, quality of life) with score ranging from 0-100. Change in individual items will be compared within- and between- groups.
    Changes in Anxiety and Depression
    The four-item patient health questionnaire (PHQ-4) for anxiety and depression is a validated questionnaire assessing mood, with higher scores representing worse mood. Change in scores will be compared within- and between- groups
    Changes in Somatic Symptom reporting
    The validated patient health questionnaire-12 assess extra-intestinal somatic symptoms, with higher scores representing greater somatic symptom severity. Change in scores will be compared within- and between- groups
    Changes in quality of life
    The validated Short form 8 Quality of life Questionnaire assesses quality of life, with higher scores representing better quality of life. Change in scores will be compared within- and between- groups
    Dietary satisfaction to assigned intervention
    The Diet Satisfaction Score is a 10-item questionnaire assessing dietary satisfaction to an allocated diet (either Mediterranean diet or traditional diet), with higher scores representing greater satisfaction. Changes in score will be compared between the groups.
    Adherence to the Mediterranean diet
    The 14-point Mediterranean Diet Adherence Screener will check adequate dietary adherence, which we expect will be seen in those assigned a Mediterranean diet compared with traditional diet. Higher scores represent better adherence.
    Changes in nutritional intake
    The Comprehensive Nutritional Assessment Questionnaire assesses macronutrient and micronutrient intake, FODMAPs, fibre, starch, glycaemic index/load. Change in scores will be compared within- and between- groups. Only a subset will complete this

    Full Information

    First Posted
    July 25, 2023
    Last Updated
    August 2, 2023
    Sponsor
    Sheffield Teaching Hospitals NHS Foundation Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05985018
    Brief Title
    Traditional Dietary Advice Vs. Mediterranean Diet in IBS
    Official Title
    A Randomized Trial of Traditional Dietary Advice Versus Mediterranean Diet in Irritable Bowel Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    July 2024 (Anticipated)
    Study Completion Date
    July 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sheffield Teaching Hospitals NHS Foundation Trust

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Irritable bowel syndrome (IBS) affects 5-10% of the population, and incurs substantial health impairment and healthcare utilization. Over 80% of individuals with IBS report food to trigger or aggravate symptoms, with many seeking to undertake dietary modifications. Current guidelines recommend first-line therapy with the relatively straightforward traditional dietary advice, with the more complex and restrictive low FODMAP diet reserved as second-line therapy. There is emerging data suggesting that the Mediterranean diet may also improve the symptoms of IBS, although it has not yet been subject to any head-to-head randomized dietary trials to help position it within the treatment algorithm. Given the relative ease of implementing the Mediterranean diet, alongside its recognized cardio-metabolic and mental health benefits, studying its efficacy in IBS is attractive as it could potentially pave the way for another first-line dietary option being available to patients before escalating to the demanding and resource intensive second-line therapies. The investigators will perform a randomized trial comparing the clinical efficacy of traditional dietary advice vs. a Mediterranean diet in IBS. Following dietary randomization, participants will complete validated questionnaires to assess changes in IBS symptoms, quality of life, mood, somatic symptoms, nutritional status, as well as dietary satisfaction and adherence.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Irritable Bowel Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    134 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Traditional Dietary Advice
    Arm Type
    Active Comparator
    Arm Description
    Its main elements are to adopt sensible eating habits and avoid excess fatty foods, spicy foods, processed foods, caffeine, fizzy drinks and alcohol.
    Arm Title
    Mediterranean Diet
    Arm Type
    Active Comparator
    Arm Description
    The principle components is a diet rich in vegetables, pulses, whole grains, and olive oil
    Intervention Type
    Other
    Intervention Name(s)
    Traditional Diet
    Intervention Description
    Provided as an educational leaflet
    Intervention Type
    Other
    Intervention Name(s)
    Mediterranean Diet
    Intervention Description
    Provided as an educational leaflet
    Primary Outcome Measure Information:
    Title
    Proportion of IBS patients experiencing clinical response with traditional dietary advice vs. Mediterranean diet
    Description
    IBS symptom severity scale (IBS-SSS) where a 50-point reduction denotes a meaningful clinical response
    Time Frame
    Baseline to Week 6
    Secondary Outcome Measure Information:
    Title
    Changes in individual items of the IBS-SSS
    Description
    IBS- SSS contains 5 specific questions (pain severity, pain frequency, abdominal distension severity, bowel movement satisfaction, quality of life) with score ranging from 0-100. Change in individual items will be compared within- and between- groups.
    Time Frame
    Baseline to Week 6
    Title
    Changes in Anxiety and Depression
    Description
    The four-item patient health questionnaire (PHQ-4) for anxiety and depression is a validated questionnaire assessing mood, with higher scores representing worse mood. Change in scores will be compared within- and between- groups
    Time Frame
    Baseline to Week 6
    Title
    Changes in Somatic Symptom reporting
    Description
    The validated patient health questionnaire-12 assess extra-intestinal somatic symptoms, with higher scores representing greater somatic symptom severity. Change in scores will be compared within- and between- groups
    Time Frame
    Baseline to Week 6
    Title
    Changes in quality of life
    Description
    The validated Short form 8 Quality of life Questionnaire assesses quality of life, with higher scores representing better quality of life. Change in scores will be compared within- and between- groups
    Time Frame
    Baseline to Week 6
    Title
    Dietary satisfaction to assigned intervention
    Description
    The Diet Satisfaction Score is a 10-item questionnaire assessing dietary satisfaction to an allocated diet (either Mediterranean diet or traditional diet), with higher scores representing greater satisfaction. Changes in score will be compared between the groups.
    Time Frame
    Week 6
    Title
    Adherence to the Mediterranean diet
    Description
    The 14-point Mediterranean Diet Adherence Screener will check adequate dietary adherence, which we expect will be seen in those assigned a Mediterranean diet compared with traditional diet. Higher scores represent better adherence.
    Time Frame
    Week 6
    Title
    Changes in nutritional intake
    Description
    The Comprehensive Nutritional Assessment Questionnaire assesses macronutrient and micronutrient intake, FODMAPs, fibre, starch, glycaemic index/load. Change in scores will be compared within- and between- groups. Only a subset will complete this
    Time Frame
    Baseline to Week 6

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: IBS Symptom Severity Scale(IBS-SSS) > 75 Online access English literate Exclusion Criteria: Organic gastrointestinal diseases (e.g. inflammatory bowel disease, GI cancer, coeliac disease, microscopic colitis, bile acid diarrhoea) Major abdominal surgery (except laparoscopy, appendectomy, cholecystectomy) History of eating disorder Body mass index <20 Current dietary interventions Current use of opioids/antibiotics Titrating dose of neuromodulators Severe systemic disease (e.g. cardiac, renal, respiratory, psychiatric) necessitating frequent medical consultations/hospitilisations Pregnant Diabetes mellitus Scleroderma Memory impairment
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jemima Clarke
    Phone
    01142265943
    Email
    sth.researchadministration@nhs.net
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Imran Aziz
    Organizational Affiliation
    Sheffield Teaching Hospitals NHS Foundation Trust
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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