CompletedNot Applicable

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

Germany24 participantsStarted 2020-05-15

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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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

What they're measuring

Change of IBS-SSS Total score

Timeframe: 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).)

Trial details

NCT IDNCT04401956

SponsorUniversity of Hohenheim

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-08-10

View on ClinicalTrials.gov More Non-celiac Gluten Sensitivity trials