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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05312788
• Other study ID #: ASRB001313/EB/IBMS
• Status: Completed
• Phase: N/A
• Start date: May 4, 2022
• Est. completion date: August 10, 2022

Study information

• Verified date: April 2023
• Source: Khyber Medical University Peshawar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 10, 2022
• Est. primary completion date: August 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Kidney Diseases

Intervention

Other:
• Effect of Barley Supplemented Wheat Bread on markers of Cardiovascular and Renal Health
Intervention will involve intake of 50% barley substituted wheat bread.

Locations

Country	Name	City	State
Pakistan	Khyber Medical University, Peshawar	Peshawar	KPK

Sponsors (1)

Lead Sponsor	Collaborator
Khyber Medical University Peshawar

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

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