Clinical trial NCT02936362: Testing the Effect of Whole-wheat Sourdough Bread Compared to White Bread on Healthy Individuals
Official title: Testing the Effect of Whole-wheat Sourdough Bread Compared to White Bread on Healthy Individuals: Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Modification
Bread
Gastrointestinal Microbiome
Hematologic Tests
Body Weight Changes
Keywords: Bread
Microbiome
Blood tests
Sourdough bread
Dietary intervention
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Weizmann Institute of Science
First posted: 2016-10-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes to glycemic control
timeFrame: One week
measure: Changes to glycemic control
timeFrame: One week
Secondary outcomes:
measure: Changes to total cholesterol levels (mg/dl)
timeFrame: One week
measure: Changes to HDL cholesterol levels (mg/dl)
timeFrame: One week
measure: Changes to LDL cholesterol levels (mg/dl)
timeFrame: One week
measure: Changes to triglycerides levels (mg/dl)
timeFrame: One week
measure: Changes to C-Reactive Protein (CRP) levels (mg/l)
timeFrame: One week
measure: Changes to weight (Kg.)
timeFrame: One week
measure: Changes to Basal Metabolic Rate (BMR; J)
timeFrame: One week
measure: Changes to blood pressure (mmHg)
timeFrame: One week
measure: Changes to Alanine Transaminase (ALT) levels (IU/l)
timeFrame: One week
measure: Changes to Aspartate Transaminase (AST) levels (IU/I)
timeFrame: One week
measure: Changes to Gamma-Glutamyl Transpeptidase (GGT) levels (IU/l)
timeFrame: One week
measure: Changes to Creatinine levels (mg/dl)
timeFrame: One week
measure: Changes to Magnesium levels (mg/dl)
timeFrame: One week
measure: Changes to Calcium levels (mg/dl)
timeFrame: One week
measure: Changes to Iron levels (mg/dl)
timeFrame: One week
measure: Changes to Urea levels (mg/dl)
timeFrame: One week
measure: Changes to Lactate Dehydrogenase (LDH) levels
timeFrame: One week
measure: Changes to Thyroid Stimulating Hormone (TSH)
timeFrame: One week D
Other outcomes:
measure: Changes to gut microbiome composition and function
timeFrame: One week
Locations:
city: Rehovot
country: Israel
facility: Weizmann Institute of Science
city: Tel Aviv
country: Israel
facility: Department of Gastroentherology
Study officials:
References: