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

Not Applicable

Completed

• Conditions: Cardiovascular Diseases; Kidney Diseases
• Interventions: Other: Effect of Barley Supplemented Wheat Bread on markers of Cardiovascular and Renal Health

• Registration Number: NCT05312788
• Lead Sponsor: Khyber Medical University Peshawar

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-28
• Study First Submitted QC: 2022-04-01
• Study First Posted: 2022-04-06
• Study Start: 2022-05-04
• Primary Completion: 2022-08-10
• Study Completion: 2022-08-10
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-24
• Last Update Posted: 2024-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Whole wheat bread	Effect of Barley Supplemented Wheat Bread on markers of Cardiovascular and Renal Health	Whole wheat bread will be used as control bread.
Barley supplemented wheat bread	Effect of Barley Supplemented Wheat Bread on markers of Cardiovascular and Renal Health	Barley supplemented wheat bread (50% substitution) will be used as experimental bread.

Primary Outcome Measures

Name	Time	Method
Change in Serum Nitric oxide from baseline to 4 weeks	Baseline and after 4 weeks
change in Serum E-selectin from baseline to 4 weeks	Baseline and after 4 weeks
Change in Serum P-cresyl sulfate from baseline to 4 weeks	Baseline and after 4 weeks
Change in Serum Thiobarbituric acid reactive substances (TBARs) from baseline to 4 weeks	Baseline and after 4 weeks
Change in Serum Total antioxidant capacity (TAC) from baseline to 4 weeks	Baseline and after 4 weeks
Change in Serum Indoxyl sulfate from baseline to 4 weeks	Baseline and after 4 weeks

Trial Locations

Locations (1)

Khyber Medical University, Peshawar; 🇵🇰 Peshawar, KPK, Pakistan