Clinical trial NCT04677881: Health Effects of Different Types of Bread
Official title: Health Effects and Consumer Aspects of Different Types of Bread
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IBS
Lead sponsor: Oslo Metropolitan University
Sponsor class: OTHER
Collaborators: name: University of Oslo
name: Mesterbakeren
First posted: 2020-12-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Gastrointestinal Symptom Rating Scale-irritable bowl syndrome (GSRS-IBS)
timeFrame: 5 weeks
Secondary outcomes:
measure: Bristol stool chart (BSC)
timeFrame: 5 weeks
measure: Blood C-peptide, total cholesterol, triglycerides, fatty acid profile, and short chain fatty acids
timeFrame: 5 weeks
measure: Feces microbiota analysis performed with Bio-Me's Precision Microbiome Profiling platform (PMP™)
timeFrame: 5 weeks
measure: Iron, selenium and zinc in blood
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Vibeke Telle-Hansen
Study officials:
affiliation: Oslo and Akershus University College
name: Vibeke Telle-Hansen, PhD
role: PRINCIPAL_INVESTIGATOR
References: