Body Weight Changes, Bread, Dietary Modification, Gastrointestinal Microbiome, Hematologic Tests
Conditions
Keywords
Bread, Microbiome, Blood tests, Sourdough bread, Dietary intervention
Brief summary
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.
Interventions
OTHERConsumption of sourdough bread
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)
OTHERConsumption of white bread
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)
Sponsors
Weizmann Institute of Science
Tel-Aviv Sourasky Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes to glycemic control | One week | Measured as response to an Oral Glucose Tolerance Test (OGTT; mg/dl\*h). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes to LDL cholesterol levels (mg/dl) | One week | Measured by a blood test. |
| Changes to triglycerides levels (mg/dl) | One week | Measured by a blood test. |
| Changes to total cholesterol levels (mg/dl) | One week | Measured by a blood test. |
| Changes to C-Reactive Protein (CRP) levels (mg/l) | One week | Measured by a blood test. |
| 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) | One week | Measured by a blood test. |
| Changes to HDL cholesterol levels (mg/dl) | One week | Measured by a blood test. |
| Changes to Gamma-Glutamyl Transpeptidase (GGT) levels (IU/l) | One week | Measured by a blood test. |
| Changes to Creatinine levels (mg/dl) | One week | Measured by a blood test. |
| Changes to Magnesium levels (mg/dl) | One week | Measured by a blood test. |
| Changes to Calcium levels (mg/dl) | One week | Measured by a blood test. |
| Changes to Iron levels (mg/dl) | One week | Measured by a blood test. |
| Changes to Urea levels (mg/dl) | One week | Measured by a blood test. |
| Changes to Lactate Dehydrogenase (LDH) levels | One week | Measured by a blood test (IU/l) |
| Changes to Thyroid Stimulating Hormone (TSH) | One week D | Measured by a blood test (mIU/ml) |
| Changes to Aspartate Transaminase (AST) levels (IU/I) | One week | Measured by a blood test. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes to gut microbiome composition and function | One week | Measured by metagenomic sequencing |
Countries
Israel
Outcome results
None listed