NCT04401956

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

May 15, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 26, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2021

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2021

Completed
Last Updated

October 27, 2021

Status Verified

October 1, 2021

Enrollment Period

1.2 years

First QC Date

May 14, 2020

Last Update Submit

October 26, 2021

Conditions

Non-celiac Gluten SensitivityWheat Intolerance

Keywords

Human NutritionNCWSSpeltWheat Bread

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Extraintestinal Symptoms

    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

    Study examinations are at baseline and after bread intervention phases (day 7, 14, 21, 28, 35, 42).

Study Arms (6)

Gluten free bread with added gluten

ACTIVE COMPARATOR

Bread will be eaten by the participants for 4 consecutive days.

Other: bread

Gluten free bread with added FODMAPs

ACTIVE COMPARATOR

Bread will be eaten by the participants for 4 consecutive days.

Other: bread

Traditional manufactured wheat bread

EXPERIMENTAL

Bread will be eaten by the participants for 4 consecutive days.

Other: bread

Traditional manufactured spelt bread

EXPERIMENTAL

Bread will be eaten by the participants for 4 consecutive days.

Other: bread

Conventional manufactured wheat bread

EXPERIMENTAL

Bread will be eaten by the participants for 4 consecutive days.

Other: bread

Conventional manufactured spelt bread

EXPERIMENTAL

Bread will be eaten by the participants for 4 consecutive days.

Other: bread

Interventions

breadOTHER

Different types of bread

Conventional manufactured spelt breadConventional manufactured wheat breadGluten free bread with added FODMAPsGluten free bread with added glutenTraditional manufactured spelt breadTraditional manufactured wheat bread

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hohenheim

Stuttgart, 70599, Germany

Location

MeSH Terms

Interventions

Bread

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Dr. med.

Study Record Dates

First Submitted

May 14, 2020

First Posted

May 26, 2020

Study Start

May 15, 2020

Primary Completion

August 10, 2021

Study Completion

September 7, 2021

Last Updated

October 27, 2021

Record last verified: 2021-10

Locations

DE(1)