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

October 26, 2021 updated by: Stephan C. Bischoff, MD, Professor, University of Hohenheim

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

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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Stuttgart, Germany, 70599
        • University of Hohenheim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Gluten free bread with added gluten
Bread will be eaten by the participants for 4 consecutive days.
Different types of bread
Active Comparator: Gluten free bread with added FODMAPs
Bread will be eaten by the participants for 4 consecutive days.
Different types of bread
Experimental: Traditional manufactured wheat bread
Bread will be eaten by the participants for 4 consecutive days.
Different types of bread
Experimental: Traditional manufactured spelt bread
Bread will be eaten by the participants for 4 consecutive days.
Different types of bread
Experimental: Conventional manufactured wheat bread
Bread will be eaten by the participants for 4 consecutive days.
Different types of bread
Experimental: Conventional manufactured spelt bread
Bread will be eaten by the participants for 4 consecutive days.
Different types of bread

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of IBS-SSS Total score
Time Frame: 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).)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extraintestinal Symptoms
Time Frame: 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).)
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).)
Blood and fecal markers
Time Frame: Study examinations are at baseline and after bread intervention phases (day 7, 14, 21, 28, 35, 42).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2020

Primary Completion (Actual)

August 10, 2021

Study Completion (Actual)

September 7, 2021

Study Registration Dates

First Submitted

May 14, 2020

First Submitted That Met QC Criteria

May 20, 2020

First Posted (Actual)

May 26, 2020

Study Record Updates

Last Update Posted (Actual)

October 27, 2021

Last Update Submitted That Met QC Criteria

October 26, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ErnMed-Brot

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non-celiac Gluten Sensitivity

Clinical Trials on bread

3
Subscribe