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Completed

NCT Number: NCT02936362

Testing the Effect of Whole-wheat Sourdough Bread Compared to White Bread on Healthy Individuals

Bread is the most common grain product in the world, with consumption surpassing 3 billion individuals per year. Sourdough whole-grain bread is considered a healthy alternative to white, refined-wheat bread.

This cross-over study will test the effect of consumption of sourdough bread compared to white bread following a short dietary intervention period (one week) on multiple clinical parameters and gut microbiota.

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Key information

Conditions

Dietary Modification Body Weight Body Weight Changes Bread Gastrointestinal Microbiome Hematologic Tests Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weizmann Institute of Science, Rehovot, Israel

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Able to provide and signed informed consent form
  • Over 18 years
  • Not in active military service
  • Ability to technically operate a glucometer

Exclusion criteria

  • Prediagnosed type I / type II diabetes mellitus
  • Pregnancy
  • Usage of antibiotics within three months prior to participation
  • Chronically active inflammatory or neoplastic disease in the three years prior to enrollment
  • Skin disease, including contact dermatitis, precluding proper attachment of the continuous glucose monitor

Treatment and study plan

Consumption of sourdough bread

Other

Participants will be given sourdough bread to consume instead of other wheat products. 145g will be consumed every morning in addition to ad libitum consumption throughout the day (matched between first and second intervention periods)

Consumption of white bread

Other

Participants will be given white bread to consume instead of other wheat products. 110g will be consumed every morning in addition to ad libitum consumption throughout the day (matched between first and second intervention periods)

Primary outcomes

  1. Changes to glycemic control

    Time frame: One week

    Measured as response to an Oral Glucose Tolerance Test (OGTT; mg/dl*h).

  2. Changes to glycemic control

    Time frame: One week

    Measured as blood glucose levels at wake-up (mg/dl).

Secondary outcomes

  1. Changes to total cholesterol levels (mg/dl)

    Time frame: One week

    Measured by a blood test.

  2. Changes to HDL cholesterol levels (mg/dl)

    Time frame: One week

    Measured by a blood test.

  3. Changes to LDL cholesterol levels (mg/dl)

    Time frame: One week

    Measured by a blood test.

  4. Changes to triglycerides levels (mg/dl)

    Time frame: One week

    Measured by a blood test.

  5. Changes to C-Reactive Protein (CRP) levels (mg/l)

    Time frame: One week

    Measured by a blood test.

  6. Changes to weight (Kg.)

    Time frame: One week

  7. Changes to Basal Metabolic Rate (BMR; J)

    Time frame: One week

  8. Changes to blood pressure (mmHg)

    Time frame: One week

  9. Changes to Alanine Transaminase (ALT) levels (IU/l)

    Time frame: One week

    Measured by a blood test.

  10. Changes to Aspartate Transaminase (AST) levels (IU/I)

    Time frame: One week

    Measured by a blood test.

  11. Changes to Gamma-Glutamyl Transpeptidase (GGT) levels (IU/l)

    Time frame: One week

    Measured by a blood test.

  12. Changes to Creatinine levels (mg/dl)

    Time frame: One week

    Measured by a blood test.

  13. Changes to Magnesium levels (mg/dl)

    Time frame: One week

    Measured by a blood test.

  14. Changes to Calcium levels (mg/dl)

    Time frame: One week

    Measured by a blood test.

  15. Changes to Iron levels (mg/dl)

    Time frame: One week

    Measured by a blood test.

  16. Changes to Urea levels (mg/dl)

    Time frame: One week

    Measured by a blood test.

  17. Changes to Lactate Dehydrogenase (LDH) levels

    Time frame: One week

    Measured by a blood test (IU/l)

  18. Changes to Thyroid Stimulating Hormone (TSH)

    Time frame: One week D

    Measured by a blood test (mIU/ml)

Other outcomes

  1. Changes to gut microbiome composition and function

    Time frame: One week

    Measured by metagenomic sequencing

Sponsors and collaborators

Lead sponsor

Tel-Aviv Sourasky Medical Center

Other Gov

Collaborators

  • Weizmann Institute of Science

Registry information

Official study title

Testing the Effect of Whole-wheat Sourdough Bread Compared to White Bread on Healthy Individuals: Randomized Trial

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Oct 18, 2016
Registry last updated
Oct 18, 2016

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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