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

Dietary Modification Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02936362
• Other study ID #: TASMC-12-ZH-658A
• Status: Completed
• Phase: N/A
• First received: October 13, 2016
• Last updated: October 14, 2016
• Start date: February 2016
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Body Weight
• Body Weight Changes
• Bread
• Dietary Modification
• Gastrointestinal Microbiome
• Hematologic Tests

Intervention

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)
• 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)

Locations

Country	Name	City	State
Israel	Weizmann Institute of Science	Rehovot
Israel	Department of Gastroentherology	Tel Aviv

Sponsors (2)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center	Weizmann Institute of Science

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes to gut microbiome composition and function	Measured by metagenomic sequencing	One week	No
Primary	Changes to glycemic control	Measured as response to an Oral Glucose Tolerance Test (OGTT; mg/dl*h).	One week	No
Primary	Changes to glycemic control	Measured as blood glucose levels at wake-up (mg/dl).	One week	No
Secondary	Changes to total cholesterol levels (mg/dl)	Measured by a blood test.	One week	No
Secondary	Changes to HDL cholesterol levels (mg/dl)	Measured by a blood test.	One week	No
Secondary	Changes to LDL cholesterol levels (mg/dl)	Measured by a blood test.	One week	No
Secondary	Changes to triglycerides levels (mg/dl)	Measured by a blood test.	One week	No
Secondary	Changes to C-Reactive Protein (CRP) levels (mg/l)	Measured by a blood test.	One week	No
Secondary	Changes to weight (Kg.)		One week	No
Secondary	Changes to Basal Metabolic Rate (BMR; J)		One week	No
Secondary	Changes to blood pressure (mmHg)		One week	No
Secondary	Changes to Alanine Transaminase (ALT) levels (IU/l)	Measured by a blood test.	One week	No
Secondary	Changes to Aspartate Transaminase (AST) levels (IU/I)	Measured by a blood test.	One week	No
Secondary	Changes to Gamma-Glutamyl Transpeptidase (GGT) levels (IU/l)	Measured by a blood test.	One week	No
Secondary	Changes to Creatinine levels (mg/dl)	Measured by a blood test.	One week	No
Secondary	Changes to Magnesium levels (mg/dl)	Measured by a blood test.	One week	No
Secondary	Changes to Calcium levels (mg/dl)	Measured by a blood test.	One week	No
Secondary	Changes to Iron levels (mg/dl)	Measured by a blood test.	One week	No
Secondary	Changes to Urea levels (mg/dl)	Measured by a blood test.	One week	No
Secondary	Changes to Lactate Dehydrogenase (LDH) levels	Measured by a blood test (IU/l)	One week	No
Secondary	Changes to Thyroid Stimulating Hormone (TSH)	Measured by a blood test (mIU/ml)	One week D	No