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

Not Applicable

Completed

• Conditions: Bread; Hematologic Tests; Dietary Modification; Gastrointestinal Microbiome; Body Weight Changes

• Registration Number: NCT02936362
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Primary Completion: 2016-05
• Study Completion: 2016-09
• Status Verified: 2016-10
• Study First Submitted: 2016-10-13
• Study First Submitted QC: 2016-10-14
• Last Update Submitted: 2016-10-14
• Study First Posted: 2016-10-18
• Last Update Posted: 2016-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Changes to glycemic control	One week	Measured as blood glucose levels at wake-up (mg/dl).

Secondary Outcome Measures

Name	Time	Method
Changes to triglycerides levels (mg/dl)	One week	Measured by a blood test.
Changes to Creatinine levels (mg/dl)	One week	Measured by a blood test.
Changes to LDL 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 blood pressure (mmHg)	One week
Changes to Alanine Transaminase (ALT) levels (IU/l)	One week	Measured by a blood test.
Changes to Aspartate Transaminase (AST) levels (IU/I)	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 Urea 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 HDL cholesterol levels (mg/dl)	One week	Measured by a blood test.
Changes to Basal Metabolic Rate (BMR; J)	One week
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 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)

Trial Locations

Locations (2)

Weizmann Institute of Science; 🇮🇱 Rehovot, Israel

Department of Gastroentherology; 🇮🇱 Tel Aviv, Israel