The 5Ad Diet for Functional Bowel Disorders

NCT06338189 | Completed

• 1 other identifier: USuffolk
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (8)

• Abdominal Pain

  Abdominal pain will be recorded daily in a symptom diary and measured using a 4 point Likert-type scale, coded from 0 - 10 for conversion into continuous variables (None = 0; Mild = 1 - 3; Moderate = 4 - 6 ; Severe = 7 - 10).

  Assessed daily throughout both dietary protocols (7 days for each dietary protocol)

• Abdominal Bloating

  Abdominal bloating will be recorded daily in a symptom diary and measured using a 4 point Likert-type scale, coded from 0 - 10 for conversion into continuous variables (None = 0; Mild = 1 - 3; Moderate = 4 - 6 ; Severe = 7 - 10).

  Assessed daily throughout both dietary protocols (7 days for each dietary protocol)

• Flatulence

  Flatulence will be recorded daily in a symptom diary and measured using a 4 point Likert-type scale, coded from 0 - 10 for conversion into continuous variables (None = 0; Mild = 1 - 3; Moderate = 4 - 6 ; Severe = 7 - 10).

  Assessed daily throughout both dietary protocols (7 days for each dietary protocol)

• Bowel Urgency

  Bowel urgency will be recorded daily in a symptom diary and measured using a 4 point Likert-type scale, coded from 0 - 10 for conversion into continuous variables (None = 0; Mild = 1 - 3; Moderate = 4 - 6 ; Severe = 7 - 10).

  Assessed daily throughout both dietary protocols (7 days for each dietary protocol)

• Straining

  Straining will be recorded daily in a symptom diary and measured using a 4 point Likert-type scale, coded from 0 - 10 for conversion into continuous variables (None = 0; Mild = 1 - 3; Moderate = 4 - 6 ; Severe = 7 - 10).

  Assessed daily throughout both dietary protocols (7 days for each dietary protocol)

• Incomplete Defecation

  Incomplete defection will be recorded daily in a symptom diary and measured using a 4 point Likert-type scale, coded from 0 - 10 for conversion into continuous variables (None = 0; Mild = 1 - 3; Moderate = 4 - 6 ; Severe = 7 - 10).

  Assessed daily throughout both dietary protocols (7 days for each dietary protocol)

• Stool Form

  Stool form will be measured using the Bristol Stool Form Scale. Type 1 - Separate hard lumps, like nuts (hard to pass), Type 2 - Sausage shaped, but lumpy, Type 3 - Like a sausage but with cracks on its surface, Type 4 - Like a sausage or snake, smooth and soft, Type 5 - Soft blobs with clear cut edges (passed easily), Type 6 - Fluffy pieces with ragged edges, a mushy stool, and Type 7 - Watery, no solid pieces, entirely liquid. Stool Types 1 and 2 are associated with constipation, while stool Types 5 - 7 are associated with diarrhoea. Stool Types 3 and 4 are considered normal stools.

  Assessed daily throughout both dietary protocols (7 days for each dietary protocol)

• Frequency of defecation

  Frequency of defecation will be recorded daily in a symptom diary.

  Assessed daily throughout both dietary protocols (7 days for each dietary protocol)

Secondary Outcomes (3)

• Fatigue

  Assessed on the last day of both dietary protocols (Day 7 of each dietary protocol)

• Mental Fatigue

  Assessed on the last day of both dietary protocols (Day 7 of each dietary protocol)

• Physical Fatigue

  Assessed on the last day of both dietary protocols (Day 7 of each dietary protocol)

Study Arms (2)

The 5Ad Diet

ACTIVE COMPARATOR

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.

Other: The 5Ad Diet; Other: The Low FODMAP Diet

The Low FODMAP Diet

ACTIVE COMPARATOR

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.

Other: The 5Ad Diet; Other: The Low FODMAP Diet

Interventions

The 5Ad Diet OTHER

Participants are to follow the 5Ad diet.

The 5Ad Diet; The Low FODMAP Diet

The Low FODMAP Diet OTHER

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

The 5Ad Diet; The Low FODMAP Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Suffolk: lead

Study Sites (1)

University of Suffolk

Ipswich, Suffolk, IP4 1QJ, United Kingdom

Location

Related Publications (5)

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

  PMID: 31426496 BACKGROUND

• 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.

  PMID: 31947828 BACKGROUND

• 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.

  PMID: 15948806 BACKGROUND

• 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.

  PMID: 9299672 BACKGROUND

• 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.

  PMID: 12670612 BACKGROUND

MeSH Terms

Conditions

Irritable Bowel Syndrome; Food Intolerance

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Camilla Bunn

  University of Suffolk

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: March 29, 2024
• Study Start: May 8, 2022
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

GB (1)