Bread Study: Comparison of the Tolerance of Spelt and Wheat Bread

Non-celiac Gluten Sensitivity Clinical Trial

Official title:

Comparison of the Tolerance of Spelt and Wheat Bread in Humans With Suspected NCWS Considering Different Manufacturing Processes of Bread

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04401956
• Other study ID #: ErnMed-Brot
• Status: Completed
• Phase: N/A
• Start date: May 15, 2020
• Est. completion date: September 7, 2021

Study information

• Verified date: October 2021
• Source: University of Hohenheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project aims to verify the hypothesis that spelt products are more tolerable than bread wheat products in a target group of individuals with self-diagnosed wheat sensitivity. In addition, the influence of different manufacturing processes will be considered.

Description:

Wheat cereals are known to be capable of triggering wheat allergy and celiac disease. The prevalence of both diseases is about 1%. Recently, another clinical entity was described, the non-celiac wheat sensitivity (NCWS). The origin and mechanisms of NCWS are unclear at present, but the existence of this new disease entity has been proven by double-blind placebo-controlled challenge tests. Three different grain components have been proposed as triggers of NCWS, gluten, α-amylase trypsin inhibitors or fermentable carbohydrates (FODMAPs).

It is reported that individuals with self-diagnosed NCWS quite often tolerate spelt products much better, even though spelt shows a higher gluten content than bread wheat products. Therefore, the question arises whether this putative spelt tolerance can be confirmed on an objective basis and whether the underlying molecular mechanisms can be elucidated. So far, human study addressing such questions are lacking.

This project aims to verify the hypothesis that spelt products are more tolerable than bread wheat products in a target group of individuals with self-diagnosed wheat sensitivity. In addition, the influence of different manufacturing processes on wheat sensitivity will be revealed.

For this purpose, the trial involves individuals with self-diagnosed wheat sensitivity and spelt tolerance. Six different kinds of bread will be tested, including 4 wheat and spelt breads, each of them produced following a traditional or a conventional way. Aim of this part is to objective bread wheat and spelt intolerance in a defined population. To find out whether FODMAPs or gluten affect the tolerance of bread, two additional breads will be tested, a gluten-free bread with added gluten and a gluten-free bread with added FODMAPs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 7, 2021
• Est. primary completion date: August 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age =18 =70 years

• Signed declaration of consent

• Willingness to adhere to the prescribed diet for the duration of the study

• Subjective bread wheat intolerance

• No known spelled intolerance

• No acute or chronic gastrointestinal diseases (e.g. celiac disease / wheat allergy)

• No participation in another clinical trial (current or within the past 30 days)

• Gluten-containing diet at least 6 weeks before the start of the study

Exclusion Criteria:

• Taking intestinal therapeutics, antibiotics, immunosuppressants or similar

• Pregnancy / lactation

• Relevant violations of the nutritional protocol

• Occurrence of relevant diseases (possibly individual decision)

• Revocation of consent

• Accommodation in a clinic or similar facility based on an official or judicial order

Related Conditions & MeSH terms

• Hypersensitivity
• Non-celiac Gluten Sensitivity
• Wheat Intolerance

Intervention

Other:
• bread
Different types of bread

Locations

Country	Name	City	State
Germany	University of Hohenheim	Stuttgart

Sponsors (1)

Lead Sponsor	Collaborator
University of Hohenheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of IBS-SSS Total score	IBS-SSS Total score will be collected with a questionnaire	Study examinations are at baseline, after wash out phases (day 3, 10, 17, 24, 31, 38) and after bread intervention phases (day 7, 14, 21, 28, 35, 42).)
Secondary	Extraintestinal Symptoms	The study team will ask the participants for typical extraintestinal symptoms in NCWS like headache, foggy-mind, nausea, heartburn, exhaustion	Study examinations are at baseline, after wash out phases (day 3, 10, 17, 24, 31, 38) and after bread intervention phases (day 7, 14, 21, 28, 35, 42).)
Secondary	Blood and fecal markers	Change of blood- and fecal markers that will reveal inflammation or intestinal permeability (Anti-gliadin Immunglobulin G antibody, lipase, ferritin, zonulin, calprotectin and lactoferrin)	Study examinations are at baseline and after bread intervention phases (day 7, 14, 21, 28, 35, 42).