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Completed

NCT Number: NCT04401956

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Hohenheim

Stuttgart, 70599, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bread

Other

Different types of bread

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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)

Sponsors and collaborators

Lead sponsor

University of Hohenheim

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 26, 2020
Registry last updated
Oct 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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