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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

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

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Studies a U.S. FDA-regulated Device Product

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

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

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

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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

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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

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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

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

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