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

Study Overview
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Brief Summary
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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.

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

Conditions
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Bread, Dietary Modification, Gastrointestinal Microbiome, Hematologic Tests, Body Weight Changes

Intervention / Treatment
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* Other: Consumption of sourdough bread
* Other: Consumption of white bread


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sourdough bread, white bread<br>Consumption of sourdough bread for one week, 2 week washout, consumption of white bread for one week | Other: Consumption of sourdough bread<br>* 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)<br>Other: Consumption of white bread<br>* 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)<br>|
| Other: White bread, sourdough bread<br>Consumption of white bread for one week, 2 week washout, consumption of sourdough bread for one week | Other: Consumption of sourdough bread<br>* 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)<br>Other: Consumption of white bread<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes to glycemic control | Measured as response to an Oral Glucose Tolerance Test (OGTT; mg/dl*h). | One week | 
| Changes to glycemic control | Measured as blood glucose levels at wake-up (mg/dl). | One week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes to total cholesterol levels (mg/dl) | Measured by a blood test. | One week | 
| Changes to HDL cholesterol levels (mg/dl) | Measured by a blood test. | One week | 
| Changes to LDL cholesterol levels (mg/dl) | Measured by a blood test. | One week | 
| Changes to triglycerides levels (mg/dl) | Measured by a blood test. | One week | 
| Changes to C-Reactive Protein (CRP) levels (mg/l) | Measured by a blood test. | One week | 
| Changes to weight (Kg.) |  | One week | 
| Changes to Basal Metabolic Rate (BMR; J) |  | One week | 
| Changes to blood pressure (mmHg) |  | One week | 
| Changes to Alanine Transaminase (ALT) levels (IU/l) | Measured by a blood test. | One week | 
| Changes to Aspartate Transaminase (AST) levels (IU/I) | Measured by a blood test. | One week | 
| Changes to Gamma-Glutamyl Transpeptidase (GGT) levels (IU/l) | Measured by a blood test. | One week | 
| Changes to Creatinine levels (mg/dl) | Measured by a blood test. | One week | 
| Changes to Magnesium levels (mg/dl) | Measured by a blood test. | One week | 
| Changes to Calcium levels (mg/dl) | Measured by a blood test. | One week | 
| Changes to Iron levels (mg/dl) | Measured by a blood test. | One week | 
| Changes to Urea levels (mg/dl) | Measured by a blood test. | One week | 
| Changes to Lactate Dehydrogenase (LDH) levels | Measured by a blood test (IU/l) | One week | 
| Changes to Thyroid Stimulating Hormone (TSH) | Measured by a blood test (mIU/ml) | One week D | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bread, Microbiome, Blood tests, Sourdough bread, Dietary intervention