Effect of Barley Supplemented Wheat Bread on Markers of Cardiovascular and Renal Health
Primary Purpose
Cardiovascular Diseases, Kidney Diseases
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Effect of Barley Supplemented Wheat Bread on markers of Cardiovascular and Renal Health
Sponsored by
About this trial
This is an interventional prevention trial for Cardiovascular Diseases focused on measuring TBARs, TAC, pCS, Barley, Beta-glucan, E-selectin, NO
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
Sites / Locations
- Khyber Medical University, Peshawar
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Whole wheat bread
Barley supplemented wheat bread
Arm Description
Whole wheat bread will be used as control bread.
Barley supplemented wheat bread (50% substitution) will be used as experimental bread.
Outcomes
Primary Outcome Measures
Change in Serum Thiobarbituric acid reactive substances (TBARs) from baseline to 4 weeks
Change in Serum Total antioxidant capacity (TAC) from baseline to 4 weeks
Change in Serum Nitric oxide from baseline to 4 weeks
change in Serum E-selectin from baseline to 4 weeks
Change in Serum P-cresyl sulfate from baseline to 4 weeks
Change in Serum Indoxyl sulfate from baseline to 4 weeks
Secondary Outcome Measures
Full Information
NCT ID
NCT05312788
First Posted
February 28, 2022
Last Updated
April 6, 2023
Sponsor
Khyber Medical University Peshawar
1. Study Identification
Unique Protocol Identification Number
NCT05312788
Brief Title
Effect of Barley Supplemented Wheat Bread 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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
May 4, 2022 (Actual)
Primary Completion Date
August 10, 2022 (Actual)
Study Completion Date
August 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khyber Medical University Peshawar
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Kidney Diseases
Keywords
TBARs, TAC, pCS, Barley, Beta-glucan, E-selectin, NO
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Whole wheat bread
Arm Type
Placebo Comparator
Arm Description
Whole wheat bread will be used as control bread.
Arm Title
Barley supplemented wheat bread
Arm Type
Experimental
Arm Description
Barley supplemented wheat bread (50% substitution) will be used as experimental bread.
Intervention Type
Other
Intervention Name(s)
Effect of Barley Supplemented Wheat Bread on markers of Cardiovascular and Renal Health
Intervention Description
Intervention will involve intake of 50% barley substituted wheat bread.
Primary Outcome Measure Information:
Title
Change in Serum Thiobarbituric acid reactive substances (TBARs) from baseline to 4 weeks
Time Frame
Baseline and after 4 weeks
Title
Change in Serum Total antioxidant capacity (TAC) from baseline to 4 weeks
Time Frame
Baseline and after 4 weeks
Title
Change in Serum Nitric oxide from baseline to 4 weeks
Time Frame
Baseline and after 4 weeks
Title
change in Serum E-selectin from baseline to 4 weeks
Time Frame
Baseline and after 4 weeks
Title
Change in Serum P-cresyl sulfate from baseline to 4 weeks
Time Frame
Baseline and after 4 weeks
Title
Change in Serum Indoxyl sulfate from baseline to 4 weeks
Time Frame
Baseline and after 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Khyber Medical University, Peshawar
City
Peshawar
State/Province
KPK
ZIP/Postal Code
25000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28107445
Citation
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.
Results Reference
background
PubMed Identifier
25147155
Citation
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.
Results Reference
background
PubMed Identifier
26236103
Citation
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.
Results Reference
background
PubMed Identifier
31590437
Citation
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.
Results Reference
background
Learn more about this trial
Effect of Barley Supplemented Wheat Bread on Markers of Cardiovascular and Renal Health
We'll reach out to this number within 24 hrs