Health Effects of Different Types of Bread

Not Applicable

Completed

• Conditions: IBS
• Interventions: Other: Intervention group

• Registration Number: NCT04677881
• Lead Sponsor: Oslo Metropolitan University

Brief Summary

Dietary fiber is well known to have health promoting effects, including reduced blood glucose and cholesterol levels. Bread is the most important source of dietary fiber in the Norwegian diet. Production of bread has changed from the traditionally use of sourdough, to yeast (Saccharomyces cerevisiae) as the dominating leavening agent in modern industrial production. Sourdough naturally contains bacteria, and through the fermentation process these bacteria release several components that are not found in modern bread using yeast. It has been shown that sourdough may have positive health effects, including on blood glucose regulation. The aim of the project is to investigate if intake of sourdough may give positive health effects compared to beard with yeast.

Detailed Description

The investigators aim to include approximately 20 participants in this randomized controlled double-blind cross-over study lasting for 5 weeks.

All participants will be given bread baked with yeast for a 2 weeks run-in period. The participants will then be randomly assigned to either 1 week intervention with bread baked with yeast or sourdough, before a 1 week wash-out period with yeast bread. During the last 1 week intervention period the participants starting with bread baked with yeast will be given sourdough and vice versa.

Questionnaires (GSRS-IBS, BSC, FFQ), blood samples, and feces samples will be collected before and after the intervention periods.

Study Timeline

• Study Start: 2020-09-01
• Status Verified: 2020-10
• Study First Submitted: 2020-11-26
• Study First Submitted QC: 2020-12-16
• Primary Completion: 2020-12-20
• Study First Posted: 2020-12-21
• Study Completion: 2020-12-31
• Last Update Submitted: 2021-05-11
• Last Update Posted: 2021-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• healthy adults who restrict their intake of bread due to stomach ache.

Exclusion Criteria

• Chronic metabolic diseases, such as diabetes type 1 or 2, cardiovascular diseases and cancer last 6 months
• Gut diseases, including Chron's disease, ulcers colitis
• Food allergies or intolerance
• Pregnant and/or lactating
• Smokers
• BMI <18,5 and >27 kg/m2
• Planed weight reduction and/or ± 5% weight change last 3 months
• Blood donor last 2 months and during the study period
• Not willing to quit taking dietary supplements, including probiotics, cod liver oil etc., 4 weeks prior to study start and during the study
• Use of antibiotics <3 months prior to study start and during the study
• Alcohol intake >40 g/day
• Hormone treatment (except contraceptives)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Wholegrain bread with sourdough	Intervention group	The experimental group will be given min. 5 slices of bread baked with sourdough per day.
Wholegrain bread with yeast	Intervention group	The control group will be given min. 5 slices of bread baked with yeast per day.

Primary Outcome Measures

Name	Time	Method
Gastrointestinal Symptom Rating Scale-irritable bowl syndrome (GSRS-IBS)	5 weeks	GSRS-IBS analysis after intervention with bread baked with yeast versus sourdough with the following response scale: 1 (no discomfort at all) to 7 (very severe discomfort)

Secondary Outcome Measures

Name	Time	Method
Blood C-peptide, total cholesterol, triglycerides, fatty acid profile, and short chain fatty acids	5 weeks	Blood analyses of C-peptide, total cholesterol, triglycerides, fatty acid profile, and short chain fatty acids after intervention with bread baked with yeast versus sourdough
Bristol stool chart (BSC)	5 weeks	BSC analyses after intervention with bread baked with yeast versus sourdough with a scale from 1 (separate hard lumps, like nuts) to 7 (watery, no solid pieces)
Iron, selenium and zinc in blood	5 weeks	Blood analysis of iron, selenium and zinc after intervention with bread baked with yeast versus sourdough
Feces microbiota analysis performed with Bio-Me's Precision Microbiome Profiling platform (PMP™)	5 weeks	Feces analyses of microbiota after intervention with bread baked with yeast versus sourdough

Trial Locations

Locations (1)

Vibeke Telle-Hansen; 🇳🇴 Oslo, Norway