Effects of Different Bread Types in NCWS

NCT ID: NCT04084470

Last Updated: 2023-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-17
• Study Completion Date: 2022-12-20

Brief Summary

Although wheat and gluten containing food products are generally considered to be healthy, a large number of individuals in the general population reduces or limits their intake and/or replaces wheat by other grains because of possible symptoms. This non-coeliac wheat sensitivity (NCWS) is accompanied by a range of (extra-)intestinal complaints soon after consuming wheat, which improve after wheat withdrawal. Evidence for a biological mechanism and for the exact contributing compound is limited. Furthermore, the impact of grain type, bread processing and the resulting compositional changes in bread on gastrointestinal tolerability in NCWS is unclear, especially as consumed part of a typical daily human diet.

The objective of this study is to investigate the effects of well-characterised breads on (extra-)intestinal symptoms in individuals with NWGS using two double-blind randomized cross-over design (study A and B). Subjects are required to avoid any products that cause GI symptoms (e.g. wheat products) during the trial. The investigators hypothesize that grain type and processing will have a different effect on the primary outcomes.

In addition, we want to explore the in vitro effect of each bread type on gut microbiota composition and activity.

Conditions

Non-Coeliac Wheat Sensitivity (NCWS)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Bread types 1, 2 and 3

Daily consumption of 5 slices of allocated bread type for three intervention days (separated by a wash-out period of at least 7 days).

Group Type: ACTIVE_COMPARATOR

Different types of bread

Intervention Type: DIETARY_SUPPLEMENT

Two studies comprising a double-blind randomized cross-over study. All subjects start with a run-in period of 3 days, thereafter they will receive three different types of bread in a randomized order for 1 day each, with a wash-out period of at least 7 days in between. Before test days 2 and 3, there is also a run-in period of three days.

Bread types 4, 5 and 6

Daily consumption of 5 slices of allocated bread type for three intervention days (separated by a wash-out period of at least 7 days).

Group Type: ACTIVE_COMPARATOR

Different types of bread

Intervention Type: DIETARY_SUPPLEMENT

Two studies comprising a double-blind randomized cross-over study. All subjects start with a run-in period of 3 days, thereafter they will receive three different types of bread in a randomized order for 1 day each, with a wash-out period of at least 7 days in between. Before test days 2 and 3, there is also a run-in period of three days.

Interventions

Different types of bread

Two studies comprising a double-blind randomized cross-over study. All subjects start with a run-in period of 3 days, thereafter they will receive three different types of bread in a randomized order for 1 day each, with a wash-out period of at least 7 days in between. Before test days 2 and 3, there is also a run-in period of three days.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Develops of self-reported GI symptoms within 12 hours after a single intake of bread;
• Age between 18-70 years;
• Asymptomatic or only mildly symptomatic (overall) GI symptoms score with VAS < 30mm) while on the gluten-free/gluten-restricted diet;
• Must have a freezer (-18ºC) to store the study breads during the study;
• Willing and able to give written informed consent and to understand, participate and comply with the research project requirements.

• (1) NCWS subject: develops GI symptoms within 12 hours after consumption of at least one of the study breads of study A or B (+15 mm on VAS); OR (2) Healthy control (sex matched to NCWS subjects): eats bread regularly (min. 5 days per week)
• Age between 18-70 years;
• Must have a fridge (4-7ºC) to shortly store the collected faecal sample.

Exclusion Criteria

• Medical history of coeliac disease, wheat allergy, inflammatory bowel disease, presence of an organic gastrointestinal (GI) disease (such as inflammatory bowel disease) or other disease which may interfere with NCWS symptoms (upon judgment of the physician-clinical investigator (Dr. Keszthelyi, Gastroenterologist MUMC+));
• Previous major abdominal surgery or radiotherapy interfering with gastrointestinal function:

• Uncomplicated appendectomy, cholecystectomy and hysterectomy allowed unless within the past 6 months;
• Other surgery may be allowed based upon judgment of the physician-clinical investigator (Dr. Keszthelyi, Gastroenterologist MUMC+), who will decide on inor exclusion based upon the surgery applied;
• Use of medication potentially influencing gastrointestinal function and/or NCWS symptoms is allowed, provided that dosing has been stable for ≥ 1 month before enrolment;
• Administration of probiotic, prebiotic supplements, investigational drugs or participation in any scientific intervention study, which may interfere with this study (to be decided by the principle investigator), in the 14 days prior to the study;
• Excessive use of alcohol (>15 alcoholic units per week), or other drugs;
• Plan to lose weight or follow a specific weight loss diet within the study period;
• Current malignancy;
• Pregnancy or breastfeeding;
• Participation in any scientific intervention study, which may interfere with this study;
• Insufficient fluency of the Dutch language.

• Use of antibiotics during the 6 past months prior to faecal sampling;
• Healthy controls: developing GI symptoms after consumption of bread, or following a gluten-free or wheat-free

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wageningen University

OTHER

Sponsor Role: collaborator

Maastricht University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daisy MAE Jonkers, Prof., PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University

Locations

Maastricht University

Maastricht, , Netherlands

Wageningen University

Wageningen, , Netherlands

Countries

Netherlands

References

de Graaf MC, Timmers E, Bonekamp B, van Rooy G, Witteman BJ, Shewry PR, Lovegrove A, America AH, Gilissen LJ, Keszthelyi D, Brouns FJ, Jonkers DMAE. Two randomized crossover multicenter studies investigating gastrointestinal symptoms after bread consumption in individuals with noncoeliac wheat sensitivity: do wheat species and fermentation type matter? Am J Clin Nutr. 2024 Apr;119(4):896-907. doi: 10.1016/j.ajcnut.2024.02.008. Epub 2024 Feb 18.

Reference Type: DERIVED

PMID: 38373694 (View on PubMed)

Other Identifiers

METC18-032

Identifier Type: OTHER

Identifier Source: secondary_id

NL67466.068.18

Identifier Type: -

Identifier Source: org_study_id