Health Effects of Different Types of Bread

IBS Clinical Trial

— HELFAB  

Official title:

Health Effects and Consumer Aspects of Different Types of Bread

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04677881
• Other study ID #: 96264
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2020
• Source: Oslo Metropolitan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2020
• Est. primary completion date: December 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• IBS

Intervention

Other:
• Intervention group
intervention group: bread with sourdough control group: bread with yeast

Locations

Country	Name	City	State
Norway	Vibeke Telle-Hansen	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Oslo Metropolitan University	Mesterbakeren, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastrointestinal Symptom Rating Scale-irritable bowl syndrome (GSRS-IBS)	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)	5 weeks
Secondary	Bristol stool chart (BSC)	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)	5 weeks
Secondary	Blood C-peptide, total cholesterol, triglycerides, fatty acid profile, and short chain fatty acids	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	5 weeks
Secondary	Feces microbiota analysis performed with Bio-Me's Precision Microbiome Profiling platform (PMP™)	Feces analyses of microbiota after intervention with bread baked with yeast versus sourdough	5 weeks
Secondary	Iron, selenium and zinc in blood	Blood analysis of iron, selenium and zinc after intervention with bread baked with yeast versus sourdough	5 weeks