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

Sponsor
Khyber Medical University Peshawar (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05312788
Collaborator
(none)
25
1
2
3
8.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Effect of Barley Supplemented Wheat Bread on markers of Cardiovascular and Renal Health
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Effect of Barley Supplemented Wheat Bread on Markers of Cardiovascular and Renal Health: A Randomized Controlled Trial
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Whole wheat bread

Whole wheat bread will be used as control bread.

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

Experimental: Barley supplemented wheat bread

Barley supplemented wheat bread (50% substitution) will be used as experimental bread.

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

Outcome Measures

Primary Outcome Measures

  1. Change in Serum Thiobarbituric acid reactive substances (TBARs) from baseline to 4 weeks [Baseline and after 4 weeks]

  2. Change in Serum Total antioxidant capacity (TAC) from baseline to 4 weeks [Baseline and after 4 weeks]

  3. Change in Serum Nitric oxide from baseline to 4 weeks [Baseline and after 4 weeks]

  4. change in Serum E-selectin from baseline to 4 weeks [Baseline and after 4 weeks]

  5. Change in Serum P-cresyl sulfate from baseline to 4 weeks [Baseline and after 4 weeks]

  6. Change in Serum Indoxyl sulfate from baseline to 4 weeks [Baseline and after 4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Khyber Medical University, Peshawar Peshawar KPK Pakistan 25000

Sponsors and Collaborators

  • Khyber Medical University Peshawar

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Bibi Hajira, Assistant Professor, Khyber Medical University Peshawar
ClinicalTrials.gov Identifier:
NCT05312788
Other Study ID Numbers:
  • ASRB001313/EB/IBMS
First Posted:
Apr 6, 2022
Last Update Posted:
Apr 6, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Bibi Hajira, Assistant Professor, Khyber Medical University Peshawar
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2022