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OpenTrials
Completed

NCT Number: NCT05312788

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

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.

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Key information

Conditions

Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Khyber Medical University, Peshawar

Peshawar, KPK, 25000, Pakistan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

Intervention will involve intake of 50% barley substituted wheat bread.

Primary outcomes

  1. Change in Serum Thiobarbituric acid reactive substances (TBARs) from baseline to 4 weeks

    Time frame: Baseline and after 4 weeks

  2. Change in Serum Total antioxidant capacity (TAC) from baseline to 4 weeks

    Time frame: Baseline and after 4 weeks

  3. Change in Serum Nitric oxide from baseline to 4 weeks

    Time frame: Baseline and after 4 weeks

  4. change in Serum E-selectin from baseline to 4 weeks

    Time frame: Baseline and after 4 weeks

  5. Change in Serum P-cresyl sulfate from baseline to 4 weeks

    Time frame: Baseline and after 4 weeks

  6. Change in Serum Indoxyl sulfate from baseline to 4 weeks

    Time frame: Baseline and after 4 weeks

Sponsors and collaborators

Lead sponsor

Khyber Medical University Peshawar

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 6, 2022
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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