The 5Ad Diet for Functional Bowel Disorders

NCT ID: NCT06338189

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-08
• Study Completion Date: 2025-04-01

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.

Conditions

Functional Bowel Disorder; Irritable Bowel Syndrome; Food Intolerance; Food Intolerance Syndromes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

The 5Ad Diet

Participants are required to follow the 5Ad diet for 7 days, followed by a washout phase for 7 days, before crossing over to the active phase of the low FODMAP diet for 7 days.

Group Type: ACTIVE_COMPARATOR

The 5Ad Diet

Intervention Type: OTHER

Participants are to follow the 5Ad diet.

The Low FODMAP Diet

Intervention Type: OTHER

Participants are to follow the active phase of the Low FODMAP diet.

The Low FODMAP Diet

Participants are required to follow the active phase of the low FODMAP diet for 7 days, followed by a washout phase for 7 days, before crossing over to the 5Ad diet for 7 days.

Group Type: ACTIVE_COMPARATOR

The 5Ad Diet

Intervention Type: OTHER

Participants are to follow the 5Ad diet.

The Low FODMAP Diet

Intervention Type: OTHER

Participants are to follow the active phase of the Low FODMAP diet.

Interventions

The 5Ad Diet

Participants are to follow the 5Ad diet.

Intervention Type: OTHER

The Low FODMAP Diet

Participants are to follow the active phase of the Low FODMAP diet.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Suffolk

OTHER

Sponsor Role: lead

Responsible Party

Camilla Bunn

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Camilla Bunn

Role: PRINCIPAL_INVESTIGATOR

University of Suffolk

Locations

University of Suffolk

Ipswich, Suffolk, United Kingdom

Countries

United Kingdom

References

Ibrahim F, Stribling P. A 5Ad Dietary Protocol for Functional Bowel Disorders. Nutrients. 2019 Aug 17;11(8):1938. doi: 10.3390/nu11081938.

Reference Type: BACKGROUND

PMID: 31426496 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31947828 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15948806 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9299672 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12670612 (View on PubMed)

Other Identifiers

USuffolk

Identifier Type: -

Identifier Source: org_study_id