Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06338189
Status:
RECRUITING
Last Update Posted:
2024-03-29
First Post:
2024-03-15
Brief Title:
The 5Ad Diet for Functional Bowel Disorders
Sponsor:
University of Suffolk
Organization:
University of Suffolk
Study Overview
Official Title:
The 5Ad Diet for Functional Bowel Disorders A Randomised Controlled Trial Against the Low FODMAP Diet
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this randomised controlled trial RCT is to compare the efficacy of the newly developed 5Ad diet against the widely researched low fermentable oligo- di- monosaccharide and polyols FODMAP diet in reducing gastrointestinal symptoms associated with functional bowel disordersfood intolerances
The primary aims of this RCT are to determine
Whether the 5Ad diet is at least as effective as the low FODMAP diet in reducing gastrointestinal symptoms associated with FBDsfood intolerances
Whether either the 5Ad diet or the low FODMAP diet are effective in reducing mental and physical fatigue
To achieve the above aims an RCT will be conducted with the 5Ad diet in one arm vs the active phase of the low FODMAP diet in the other arm in a cross-over design with a 7 days washout phase in between Both dietary protocols will be followed by each participant for 7 days
Researchers will compare the results from the 2 dietary protocols in order to ascertain the superiority of one over the other in regards to 6 gastrointestinal symptoms abdominal pain bloating flatulence bowel urgency straining and incomplete defecation stool form and frequency of defecation
The primary aims of this RCT are to determine
Whether the 5Ad diet is at least as effective as the low FODMAP diet in reducing gastrointestinal symptoms associated with FBDsfood intolerances
Whether either the 5Ad diet or the low FODMAP diet are effective in reducing mental and physical fatigue
To achieve the above aims an RCT will be conducted with the 5Ad diet in one arm vs the active phase of the low FODMAP diet in the other arm in a cross-over design with a 7 days washout phase in between Both dietary protocols will be followed by each participant for 7 days
Researchers will compare the results from the 2 dietary protocols in order to ascertain the superiority of one over the other in regards to 6 gastrointestinal symptoms abdominal pain bloating flatulence bowel urgency straining and incomplete defecation stool form and frequency of defecation
Detailed Description:
Functional Bowel Disorders FBDs are characterised by chronic gastrointestinal symptoms including abdominal pain constipation bloating diarrhoea alternating abdominal symptoms and irregular frequency of bowel movements among others in the absence of any intestinal abnormality The prevalence of FBDs ranges from 15 - 20 worldwide with remarkable economic burden on health systems and significant impact on the quality of life of sufferers It is estimated that between 60 - 89 of individuals that suffer from FBDs find that foods exacerbate their symptoms Therefore dietary therapies are frequently implemented to assist with symptom relief in these individuals
Although the low FODMAP diet is the most commonly followed diet for the treatment of FBDs there are concerns regarding its complexity restrictiveness nutritional adequacy and effectiveness Therefore the 5Ad diet was designed to fill a gap in the existing research and to overcome the limitations associated with existing dietary approaches
Preliminary findings from the first study in 2019 suggested that the 5Ad diet might be a promising universal approach for varying forms and severities of FBDs Therefore an RCT is needed to substantiate these previous results Thus this RCT aims to determine whether the 5Ad diet is at least as effective as the low FODMAP diet in reducing gastrointestinal symptoms associated with FBDsfood intolerances
Although the low FODMAP diet is the most commonly followed diet for the treatment of FBDs there are concerns regarding its complexity restrictiveness nutritional adequacy and effectiveness Therefore the 5Ad diet was designed to fill a gap in the existing research and to overcome the limitations associated with existing dietary approaches
Preliminary findings from the first study in 2019 suggested that the 5Ad diet might be a promising universal approach for varying forms and severities of FBDs Therefore an RCT is needed to substantiate these previous results Thus this RCT aims to determine whether the 5Ad diet is at least as effective as the low FODMAP diet in reducing gastrointestinal symptoms associated with FBDsfood intolerances
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None