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Completed

NCT Number: NCT04677881

Health Effects 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.

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Key information

Conditions

IBS

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vibeke Telle-Hansen

Oslo, 0130, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Intervention group

Other

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

Primary outcomes

  1. Gastrointestinal Symptom Rating Scale-irritable bowl syndrome (GSRS-IBS)

    Time frame: 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 outcomes

  1. Bristol stool chart (BSC)

    Time frame: 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)

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

    Time frame: 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

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

    Time frame: 5 weeks

    Feces analyses of microbiota after intervention with bread baked with yeast versus sourdough

  4. Iron, selenium and zinc in blood

    Time frame: 5 weeks

    Blood analysis of iron, selenium and zinc after intervention with bread baked with yeast versus sourdough

Sponsors and collaborators

Lead sponsor

Oslo Metropolitan University

Other

Collaborators

  • Mesterbakeren
  • University of Oslo

Registry information

Official study title

Health Effects and Consumer Aspects of Different Types of Bread

Acronym: HELFAB

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 21, 2020
Registry last updated
May 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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