Effect of Barley Supplemented Wheat Bread on Markers of Cardiovascular and Renal Health

Study Overview
=================
Brief Summary
-----------------
The disruption of colonic microbiota has been linked to a number of diseases, mainly cardiovascular and kidney diseases. One possible means to improve the microbiota is to increase dietary fiber intake as the intake of dietary fiber shifts the fermentation from proteolytic saccharolytic fermentation. Beta-glucans are soluble dietary fibers mainly found in oats and barley. Results from previous studies suggest that the consumption of barley reduces the risk of cardiovascular and kidney diseases. Therefore, this study will explore the effect of barley beta-glucans on markers of Cardiovascular and Renal health.

Official Title
-----------------
Effect of Barley Supplemented Wheat Bread on Markers of Cardiovascular and Renal Health: A Randomized Controlled Trial

Conditions
-----------------
Cardiovascular Diseases, Kidney Diseases

Intervention / Treatment
-----------------
* Other: Effect of Barley Supplemented Wheat Bread on markers of Cardiovascular and Renal Health


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy individuals of age 18 years or older BMI ranged between 18.5 and 24.9 Exclusion Criteria: Celiac disease, Cancer, Diabetes , cardiovascular diseases Gastro intestinal tract disease Pregnant women Use of pre-, pro- or antibiotics 15 days before the enrollment into the study Food allergy to food used in the trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Whole wheat bread<br>Whole wheat bread will be used as control bread. | Other: Effect of Barley Supplemented Wheat Bread on markers of Cardiovascular and Renal Health<br>* Intervention will involve intake of 50% barley substituted wheat bread.<br>|
| Experimental: Barley supplemented wheat bread<br>Barley supplemented wheat bread (50% substitution) will be used as experimental bread. | Other: Effect of Barley Supplemented Wheat Bread on markers of Cardiovascular and Renal Health<br>* Intervention will involve intake of 50% barley substituted wheat bread.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Serum Thiobarbituric acid reactive substances (TBARs) from baseline to 4 weeks |  | Baseline and after 4 weeks | 
| Change in Serum Total antioxidant capacity (TAC) from baseline to 4 weeks |  | Baseline and after 4 weeks | 
| Change in Serum Nitric oxide from baseline to 4 weeks |  | Baseline and after 4 weeks | 
| change in Serum E-selectin from baseline to 4 weeks |  | Baseline and after 4 weeks | 
| Change in Serum P-cresyl sulfate from baseline to 4 weeks |  | Baseline and after 4 weeks | 
| Change in Serum Indoxyl sulfate from baseline to 4 weeks |  | Baseline and after 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
E-selectin, TBARs, TAC, pCS, Barley, Beta-glucan, NO