Health Effects of Different Types of Bread (HELFAB)

Health Effects and Consumer Aspects of Different Types of Bread

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.

Study Overview

• Status: Completed
• Conditions: IBS
• Intervention / Treatment: Other: Intervention group

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0130
    • Vibeke Telle-Hansen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Wholegrain bread with yeast; The control group will be given min. 5 slices of bread baked with yeast per day.	Other: Intervention group; intervention group: bread with sourdough control group: bread with yeast
Experimental: Wholegrain bread with sourdough; The experimental group will be given min. 5 slices of bread baked with sourdough per day.	Other: Intervention group; intervention group: bread with sourdough control group: bread with yeast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Iron, selenium and zinc in blood	Blood analysis of iron, selenium and zinc after intervention with bread baked with yeast versus sourdough	5 weeks

Collaborators and Investigators

• Sponsor: Oslo Metropolitan University
• Collaborators: University of Oslo; Mesterbakeren
• Investigators: Principal Investigator: Vibeke Telle-Hansen, PhD, Oslo and Akershus University College

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): December 20, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: November 26, 2020
• First Submitted That Met QC Criteria: December 16, 2020
• First Posted (Actual): December 21, 2020

Study Record Updates

• Last Update Posted (Actual): May 12, 2021
• Last Update Submitted That Met QC Criteria: May 11, 2021
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 96264

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No