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

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

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.

Study Overview

• Status: Completed
• Conditions: Body Weight Changes; Dietary Modification; Gastrointestinal Microbiome; Bread; Hematologic Tests
• Intervention / Treatment: Other: Consumption of sourdough bread; Other: Consumption of white bread

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Rehovot, Israel
    • Weizmann Institute of Science
  • Tel Aviv, Israel, 64239
    • Department of Gastroentherology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Sourdough bread, white bread; Consumption of sourdough bread for one week, 2 week washout, consumption of white bread for one week	Other: Consumption 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); Other: Consumption 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)
Other: White bread, sourdough bread; Consumption of white bread for one week, 2 week washout, consumption of sourdough bread for one week	Other: Consumption 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); Other: Consumption 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)

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes to gut microbiome composition and function	Measured by metagenomic sequencing	One week

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center
• Collaborators: Weizmann Institute of Science

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: October 13, 2016
• First Submitted That Met QC Criteria: October 14, 2016
• First Posted (Estimate): October 18, 2016

Study Record Updates

• Last Update Posted (Estimate): October 18, 2016
• Last Update Submitted That Met QC Criteria: October 14, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Microbiome; Bread; Dietary intervention; Blood tests; Sourdough bread
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes
• Other Study ID Numbers: TASMC-12-ZH-658A