Effect of Barley Supplemented Wheat Bread on Markers of Cardiovascular and Renal Health
July 24, 2024 updated by: Bibi Hajira, Khyber Medical University Peshawar
Effect of Barley Supplemented Wheat Bread on Markers of Cardiovascular and Renal Health: A Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
KPK
-
Peshawar, KPK, Pakistan, 25000
- Khyber Medical University, Peshawar
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Whole wheat bread
Whole wheat bread will be used as control bread.
|
Intervention will involve intake of 50% barley substituted wheat bread.
|
|
Experimental: Barley supplemented wheat bread
Barley supplemented wheat bread (50% substitution) will be used as experimental bread.
|
Intervention will involve intake of 50% barley substituted wheat bread.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in Serum Thiobarbituric acid reactive substances (TBARs) from baseline to 4 weeks
Time Frame: Baseline and after 4 weeks
|
Baseline and after 4 weeks
|
|
Change in Serum Total antioxidant capacity (TAC) from baseline to 4 weeks
Time Frame: Baseline and after 4 weeks
|
Baseline and after 4 weeks
|
|
Change in Serum Nitric oxide from baseline to 4 weeks
Time Frame: Baseline and after 4 weeks
|
Baseline and after 4 weeks
|
|
change in Serum E-selectin from baseline to 4 weeks
Time Frame: Baseline and after 4 weeks
|
Baseline and after 4 weeks
|
|
Change in Serum P-cresyl sulfate from baseline to 4 weeks
Time Frame: Baseline and after 4 weeks
|
Baseline and after 4 weeks
|
|
Change in Serum Indoxyl sulfate from baseline to 4 weeks
Time Frame: Baseline and after 4 weeks
|
Baseline and after 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Sirich TL, Plummer NS, Gardner CD, Hostetter TH, Meyer TW. Effect of increasing dietary fiber on plasma levels of colon-derived solutes in hemodialysis patients. Clin J Am Soc Nephrol. 2014 Sep 5;9(9):1603-10. doi: 10.2215/CJN.00490114. Epub 2014 Aug 21.
- Cosola C, De Angelis M, Rocchetti MT, Montemurno E, Maranzano V, Dalfino G, Manno C, Zito A, Gesualdo M, Ciccone MM, Gobbetti M, Gesualdo L. Beta-Glucans Supplementation Associates with Reduction in P-Cresyl Sulfate Levels and Improved Endothelial Vascular Reactivity in Healthy Individuals. PLoS One. 2017 Jan 20;12(1):e0169635. doi: 10.1371/journal.pone.0169635. eCollection 2017.
- Bacchetti T, Tullii D, Masciangelo S, Gesuita R, Skrami E, Bruge F, Silvestri S, Orlando P, Tiano L, Ferretti G. Effect of a barley-vegetable soup on plasma carotenoids and biomarkers of cardiovascular disease. J Clin Biochem Nutr. 2015 Jul;57(1):66-73. doi: 10.3164/jcbn.15-11. Epub 2015 Jun 5.
- Gaesser GA, Rodriguez J, Patrie JT, Whisner CM, Angadi SS. Effects of Glycemic Index and Cereal Fiber on Postprandial Endothelial Function, Glycemia, and Insulinemia in Healthy Adults. Nutrients. 2019 Oct 6;11(10):2387. doi: 10.3390/nu11102387.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 4, 2022
Primary Completion (Actual)
August 10, 2022
Study Completion (Actual)
August 10, 2022
Study Registration Dates
First Submitted
February 28, 2022
First Submitted That Met QC Criteria
April 1, 2022
First Posted (Actual)
April 6, 2022
Study Record Updates
Last Update Posted (Actual)
July 25, 2024
Last Update Submitted That Met QC Criteria
July 24, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KMU/IBMS/IRBE/2022/9302
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.