Clinical trial NCT05312788: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Kidney Diseases
Keywords: TBARs
TAC
pCS
Barley
Beta-glucan
E-selectin
NO
Lead sponsor: Khyber Medical University Peshawar
Sponsor class: OTHER
First posted: 2022-04-06
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Change in Serum Thiobarbituric acid reactive substances (TBARs) from baseline to 4 weeks
timeFrame: Baseline and after 4 weeks
measure: Change in Serum Total antioxidant capacity (TAC) from baseline to 4 weeks
timeFrame: Baseline and after 4 weeks
measure: Change in Serum Nitric oxide from baseline to 4 weeks
timeFrame: Baseline and after 4 weeks
measure: change in Serum E-selectin from baseline to 4 weeks
timeFrame: Baseline and after 4 weeks
measure: Change in Serum P-cresyl sulfate from baseline to 4 weeks
timeFrame: Baseline and after 4 weeks
measure: Change in Serum Indoxyl sulfate from baseline to 4 weeks
timeFrame: Baseline and after 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Khyber Medical University, Peshawar
state: KPK
Study officials:
References:
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.
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.
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.
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.