Cardiovascular DiseasesNCT05312788
Effect of Barley Supplemented Wheat Bread on Markers of Cardiovascular and Renal Health
A study testing Effect of Barley Supplemented Wheat Bread on markers of Cardiovascular and Renal Health in people with Cardiovascular Diseases and Kidney Diseases, run by Khyber Medical University Peshawar at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Kidney Diseases
- What is being tested?
- Effect of Barley Supplemented Wheat Bread on markers of Cardiovascular and Renal Health
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 sitePakistan
- Study dates
- 4 May 2022to 10 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy individuals of age 18 years or older
- BMI ranged between 18.5 and 24.9
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Barley Supplemented Wheat Bread on Markers of Cardiovascular and Renal Health: A Randomized Controlled Trial
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.
- Conditions
- Cardiovascular Diseases, Kidney Diseases
- Being tested
- Effect of Barley Supplemented Wheat Bread on markers of Cardiovascular and Renal Health
- Keywords
- TBARs, TAC, pCS, Barley, Beta-glucan, E-selectin, NO
- Medical subject headings
- Cardiovascular Diseases, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effect of Barley Supplemented Wheat Bread on markers of Cardiovascular and Renal HealthOther
Intervention will involve intake of 50% barley substituted wheat bread.
| Study group | Role | What they receive |
|---|---|---|
| Whole wheat bread | Placebo comparator | Whole wheat bread will be used as control bread. Receives: Other: Effect of Barley Supplemented Wheat Bread on markers of Cardiovascular and Renal Health |
| Barley supplemented wheat bread | Experimental | Barley supplemented wheat bread (50% substitution) will be used as experimental bread. Receives: Other: Effect of Barley Supplemented Wheat Bread on markers of Cardiovascular and Renal Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Thiobarbituric acid reactive substances (TBARs) from baseline to 4 weeks
Measured: Baseline and after 4 weeks
Change in Serum Total antioxidant capacity (TAC) from baseline to 4 weeks
Measured: Baseline and after 4 weeks
Change in Serum Nitric oxide from baseline to 4 weeks
Measured: Baseline and after 4 weeks
change in Serum E-selectin from baseline to 4 weeks
Measured: Baseline and after 4 weeks
Change in Serum P-cresyl sulfate from baseline to 4 weeks
Measured: Baseline and after 4 weeks
Change in Serum Indoxyl sulfate from baseline to 4 weeks
Measured: Baseline and after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start4 May 2022
- Primary completion10 Aug 2022
- Study completion10 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khyber Medical University Peshawar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bibi Hajira, Khyber Medical University Peshawar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05312788
- Sponsor's protocol ID
- KMU/IBMS/IRBE/2022/9302
- Status last verified
- Jul 2024
- First submitted
- 28 Feb 2022
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28107445Sirich 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.
PubMed 25147155Bacchetti 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.
PubMed 26236103Gaesser 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.
PubMed 31590437
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Barley Supplemented Wheat Bread on Markers of Cardiovascular and Renal Health: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05312788
- Acronym / sponsor ID
- KMU/IBMS/IRBE/2022/9302
- Conditions
- Cardiovascular Diseases, Kidney Diseases
- Keywords
- TBARs, TAC, pCS, Barley, Beta-glucan, E-selectin, NO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Khyber Medical University PeshawarUniversity, hospital or other
- Study start
- 4 May 2022 (actual)
- Primary completion
- 10 Aug 2022 (actual)
- Study completion
- 10 Aug 2022 (actual)
- First posted
- 6 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole wheat bread | Placebo comparator | Other: Effect of Barley Supplemented Wheat Bread on markers of Cardiovascular and Renal HealthWhole wheat bread will be used as control bread. |
| Barley supplemented wheat bread | Experimental | Other: Effect of Barley Supplemented Wheat Bread on markers of Cardiovascular and Renal HealthBarley supplemented wheat bread (50% substitution) will be used as experimental bread. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy individuals of age 18 years or older
- BMI ranged between 18.5 and 24.9
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Effect of Barley Supplemented Wheat Bread on markers of Cardiovascular and Renal HealthIntervention will involve intake of 50% barley substituted wheat bread. | Other | Barley supplemented wheat bread, Whole wheat bread |
Primary outcome
Change in Serum Thiobarbituric acid reactive substances (TBARs) from baseline to 4 weeks
Time frame: Baseline and after 4 weeks
Change in Serum Total antioxidant capacity (TAC) from baseline to 4 weeks
Time frame: Baseline and after 4 weeks
Change in Serum Nitric oxide from baseline to 4 weeks
Time frame: Baseline and after 4 weeks
change in Serum E-selectin from baseline to 4 weeks
Time frame: Baseline and after 4 weeks
Change in Serum P-cresyl sulfate from baseline to 4 weeks
Time frame: Baseline and after 4 weeks
Change in Serum Indoxyl sulfate from baseline to 4 weeks
Time frame: Baseline and after 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Background: PubMed 28107445Cosola 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.
- Background: PubMed 25147155Sirich 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.
- Background: PubMed 26236103Bacchetti 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.
- Background: PubMed 31590437Gaesser 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Effect of Barley Supplemented Wheat Bread on markers of Cardiovascular and Renal Health in people with Cardiovascular Diseases and Kidney Diseases, run by Khyber Medical University Peshawar at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Thiobarbituric acid reactive substances (TBARs) from baseline to 4 weeks (time frame: Baseline and after 4 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05312788, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.