Clinical trial NCT06338189: The 5Ad Diet for Functional Bowel Disorders
Official title: The 5Ad Diet for Functional Bowel Disorders: A Randomised Controlled Trial Against the Low FODMAP Diet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Bowel Disorder
Irritable Bowel Syndrome
Food Intolerance
Food Intolerance Syndromes
Keywords: The 5Ad Diet
The Low FODMAP Diet
Irritable Bowel Syndrome
Functional Constipation
Functional Diarrhoea
Functional Bloating
Lead sponsor: University of Suffolk
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 disorders/food 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 FBDs/food 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 it's 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 FBDs/food intolerances.

Eligibility criteria: Inclusion Criteria:

Individuals are eligible for the study if all of the following criteria are met:

* Suffers chronically from either constipation, diarrhoea, or an alternation of both, bloating, flatulence or abdominal pain, incomplete defecation, straining and bowel urgency.
* Symptoms must be present for ≥ 2 times per week, with symptom onset occurring at least 3 months prior to participation.
* Participants taking prescribed medications which may affect bowel function are included only if the intake is maintained throughout the entire intervention period.

Exclusion Criteria:

Individuals are excluded from the study if any of the following criteria are met:

* Pregnant.
* Known underlying pathology (e.g., Crohn's disease, ulcerative colitis, celiac disease).
* History of abdominal/gastrointestinal surgery within 1 year prior to participation.
* History of antibiotic use in the last 6 weeks prior to participation.
* Allergic to the foods specified in both the 5Ad diet and the low FODMAP diet.

Primary outcomes:
measure: Abdominal Pain
timeFrame: Assessed daily throughout both dietary protocols (7 days for each dietary protocol)
measure: Abdominal Bloating
timeFrame: Assessed daily throughout both dietary protocols (7 days for each dietary protocol)
measure: Flatulence
timeFrame: Assessed daily throughout both dietary protocols (7 days for each dietary protocol)
measure: Bowel Urgency
timeFrame: Assessed daily throughout both dietary protocols (7 days for each dietary protocol)
measure: Straining
timeFrame: Assessed daily throughout both dietary protocols (7 days for each dietary protocol)
measure: Incomplete Defecation
timeFrame: Assessed daily throughout both dietary protocols (7 days for each dietary protocol)
measure: Stool Form
timeFrame: Assessed daily throughout both dietary protocols (7 days for each dietary protocol)
measure: Frequency of defecation
timeFrame: Assessed daily throughout both dietary protocols (7 days for each dietary protocol)
Secondary outcomes:
measure: Fatigue
timeFrame: Assessed on the last day of both dietary protocols (Day 7 of each dietary protocol)
measure: Mental Fatigue
timeFrame: Assessed on the last day of both dietary protocols (Day 7 of each dietary protocol)
measure: Physical Fatigue
timeFrame: Assessed on the last day of both dietary protocols (Day 7 of each dietary protocol)
Other outcomes:
Locations:
city: Ipswich
country: United Kingdom
facility: University of Suffolk
state: Suffolk
Study officials:
affiliation: University of Suffolk
name: Camilla Bunn
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ibrahim F, Stribling P. A 5Ad Dietary Protocol for Functional Bowel Disorders. Nutrients. 2019 Aug 17;11(8):1938. doi: 10.3390/nu11081938.
citation: Ibrahim F, Stribling P. Reply to "A Gluten Reduction Is the Patients' Choice for a Dietary 'Bottom Up' Approach in IBS-A Comment on "A 5Ad Dietary Protocol for Functional Bowel Disorders" Nutrients 2019, 11, 1938". Nutrients. 2020 Jan 3;12(1):140. doi: 10.3390/nu12010140.
citation: Gibson PR, Shepherd SJ. Personal view: food for thought--western lifestyle and susceptibility to Crohn's disease. The FODMAP hypothesis. Aliment Pharmacol Ther. 2005 Jun 15;21(12):1399-409. doi: 10.1111/j.1365-2036.2005.02506.x.
citation: Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol. 1997 Sep;32(9):920-4. doi: 10.3109/00365529709011203.
citation: Michielsen HJ, De Vries J, Van Heck GL. Psychometric qualities of a brief self-rated fatigue measure: The Fatigue Assessment Scale. J Psychosom Res. 2003 Apr;54(4):345-52. doi: 10.1016/s0022-3999(02)00392-6.