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

Primary Purpose

Dietary Modification, Bread, Gastrointestinal Microbiome

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Consumption of sourdough bread
Consumption of white bread
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Dietary Modification focused on measuring Bread, Microbiome, Blood tests, Sourdough bread, Dietary intervention

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Weizmann Institute of Science
  • Department of Gastroentherology

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Sourdough bread, white bread

White bread, sourdough bread

Arm Description

Consumption of sourdough bread for one week, 2 week washout, consumption of white bread for one week

Consumption of white bread for one week, 2 week washout, consumption of sourdough bread for one week

Outcomes

Primary Outcome Measures

Changes to glycemic control
Measured as response to an Oral Glucose Tolerance Test (OGTT; mg/dl*h).
Changes to glycemic control
Measured as blood glucose levels at wake-up (mg/dl).

Secondary Outcome Measures

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

Full Information

First Posted
October 13, 2016
Last Updated
October 14, 2016
Sponsor
Tel-Aviv Sourasky Medical Center
Collaborators
Weizmann Institute of Science
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1. Study Identification

Unique Protocol Identification Number
NCT02936362
Brief Title
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

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
Collaborators
Weizmann Institute of Science

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dietary Modification, Bread, Gastrointestinal Microbiome, Hematologic Tests, Body Weight Changes
Keywords
Bread, Microbiome, Blood tests, Sourdough bread, Dietary intervention

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sourdough bread, white bread
Arm Type
Other
Arm Description
Consumption of sourdough bread for one week, 2 week washout, consumption of white bread for one week
Arm Title
White bread, sourdough bread
Arm Type
Other
Arm Description
Consumption of white bread for one week, 2 week washout, consumption of sourdough bread for one week
Intervention Type
Other
Intervention Name(s)
Consumption of sourdough bread
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Consumption of white bread
Intervention Description
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)
Primary Outcome Measure Information:
Title
Changes to glycemic control
Description
Measured as response to an Oral Glucose Tolerance Test (OGTT; mg/dl*h).
Time Frame
One week
Title
Changes to glycemic control
Description
Measured as blood glucose levels at wake-up (mg/dl).
Time Frame
One week
Secondary Outcome Measure Information:
Title
Changes to total cholesterol levels (mg/dl)
Description
Measured by a blood test.
Time Frame
One week
Title
Changes to HDL cholesterol levels (mg/dl)
Description
Measured by a blood test.
Time Frame
One week
Title
Changes to LDL cholesterol levels (mg/dl)
Description
Measured by a blood test.
Time Frame
One week
Title
Changes to triglycerides levels (mg/dl)
Description
Measured by a blood test.
Time Frame
One week
Title
Changes to C-Reactive Protein (CRP) levels (mg/l)
Description
Measured by a blood test.
Time Frame
One week
Title
Changes to weight (Kg.)
Time Frame
One week
Title
Changes to Basal Metabolic Rate (BMR; J)
Time Frame
One week
Title
Changes to blood pressure (mmHg)
Time Frame
One week
Title
Changes to Alanine Transaminase (ALT) levels (IU/l)
Description
Measured by a blood test.
Time Frame
One week
Title
Changes to Aspartate Transaminase (AST) levels (IU/I)
Description
Measured by a blood test.
Time Frame
One week
Title
Changes to Gamma-Glutamyl Transpeptidase (GGT) levels (IU/l)
Description
Measured by a blood test.
Time Frame
One week
Title
Changes to Creatinine levels (mg/dl)
Description
Measured by a blood test.
Time Frame
One week
Title
Changes to Magnesium levels (mg/dl)
Description
Measured by a blood test.
Time Frame
One week
Title
Changes to Calcium levels (mg/dl)
Description
Measured by a blood test.
Time Frame
One week
Title
Changes to Iron levels (mg/dl)
Description
Measured by a blood test.
Time Frame
One week
Title
Changes to Urea levels (mg/dl)
Description
Measured by a blood test.
Time Frame
One week
Title
Changes to Lactate Dehydrogenase (LDH) levels
Description
Measured by a blood test (IU/l)
Time Frame
One week
Title
Changes to Thyroid Stimulating Hormone (TSH)
Description
Measured by a blood test (mIU/ml)
Time Frame
One week D
Other Pre-specified Outcome Measures:
Title
Changes to gut microbiome composition and function
Description
Measured by metagenomic sequencing
Time Frame
One week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Weizmann Institute of Science
City
Rehovot
Country
Israel
Facility Name
Department of Gastroentherology
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel

12. IPD Sharing Statement

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

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