Health Effects of Different Types of Bread

NCT04677881 | Completed

• 1 other identifier: 96264
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

IBS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Bristol stool chart (BSC)

  5 weeks

• Blood C-peptide, total cholesterol, triglycerides, fatty acid profile, and short chain fatty acids

  5 weeks

• Feces microbiota analysis performed with Bio-Me's Precision Microbiome Profiling platform (PMP™)

  5 weeks

• Iron, selenium and zinc in blood

  5 weeks

Study Arms (2)

Wholegrain bread with yeast

PLACEBO COMPARATOR

The control group will be given min. 5 slices of bread baked with yeast per day.

Other: Intervention group

Wholegrain bread with sourdough

EXPERIMENTAL

The experimental group will be given min. 5 slices of bread baked with sourdough per day.

Other: Intervention group

Interventions

Intervention group OTHER

intervention group: bread with sourdough control group: bread with yeast

Wholegrain bread with sourdough; Wholegrain bread with yeast

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Oslo Metropolitan University: lead
• University of Oslo: collaborator
• Mesterbakeren: collaborator

Study Sites (1)

Vibeke Telle-Hansen

Oslo, 0130, Norway

Location

Study Officials

• Vibeke Telle-Hansen, PhD

  Oslo and Akershus University College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: December 21, 2020
• Study Start: September 1, 2020
• Primary Completion: December 20, 2020
• Study Completion: December 31, 2020
• Last Updated: May 12, 2021

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)