Clinical Trial: High-selenium Lentils Versus Arsenic Toxicity

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Mitigating Arsenic Toxicity in Bangladeshi People by Supplementing Their Diets With High Selenium Lentils

Brief Summary:

About 45 million people in Bangladesh are chronically exposed to unacceptable levels of arsenic in their drinking water. Chronic arsenic poisoning leads to cancers, and vascular diseases.

This dietary trial intends to test the potential of high-selenium lentils, consumed as lentil soup, in reducing the arsenic body burden in an exposed Bangladeshi population, and in improving the overall health status.

Arsenic-exposed families will be assigned to one of two groups. One group will eat lentils (50g/person/day) that are naturally high in selenium, the other group will receive lentils with low selenium content. This 6 months trial is randomized and double-blinded.

Detailed Summary:

Chronic arsenic (As) poisoning is a worldwide public health problem. Up to 100 million people worldwide, are chronically exposed to dangerously high concentrations of As in their drinking water and food supply. Bangladesh is facing a major public health challenge - contamination of groundwater by arsenic (As). Since tube well water contamination by As was discovered in Bangladesh in the 1990s, As in drinking water has been reduced by 40%, yet approximately 45 million Bangladeshis remain at risk from high As concentrations greater than the WHO guideline value of 10 µg/L in the well water. The annual cost to treat As related health problems in Bangladesh is currently estimated up to $77.5 million. Micronutrient-deficient (e.g. Selenium) soils lead to less nutritious local foods, which becomes a partner in crime exacerbating the toxic burden incurred by As exposure.

Selenium (Se) is a trace element that is an essential component of several metabolic pathways controlling immune function. Se and As work antagonistically in the body by competing in many biological functions. Arsenic added to animal diets has been known to counteract Se toxicity/activity in animals since the 1930s. Se interacts with As to form a complex; excessive Se excretion can occur as result of Se/As complex formation under condition of chronic As ingestion and low dietary Se ingestion. This scenario may further accelerate Se depletion. Again, since Se can form a complex with As, Se supplementation, in principle, can reduce As toxicity and also decrease effects of As exposure on many other parameters, such as oxidative stress, immunotoxicity etc.

Supplementation of Se as pills is currently used to treat arsenicosis. But pills are not often well received by people and are expensive for low-income families. Lentils are a common food in Bangladesh and the
Sponsor: University of Calgary

Current Primary Outcome: arsenic body burden [ Time Frame: week 12 ]

Original Primary Outcome: arsenic body burden [ Time Frame: at day one, week 12 and week 24 ]

Current Secondary Outcome:

• Antioxidant status [ Time Frame: week 24 ]
  Blood specimen will be tested for glutathione (ox/red) levels.
• oxidative damage [ Time Frame: week 24 ]
  Blood specimen will be tested for 8-OHdG, a marker for oxidative DNA damage.
• serum lipid levels [ Time Frame: week 24 ]
  Serum will be analyzed for triglyceride, total cholesterol, HDL- and LDL-cholesterol.
• Lung inflammation test [ Time Frame: week 12 ]
  Participants will exhale into a NIOX Mino device, which measures the nitric oxide level as marker of lung inflammation
• Health and compliance questionnaires [ Time Frame: biweekly (health) for 6 months ]
  Health questionnaire (and initial sociodemographic questionnaire) will be filled in by participant every two weeks to assess overall health, and lentil consumption will be assessed weekly.
• Body mass index [ Time Frame: week 24 ]
  Examination by health professionals: Body mass index
• Blood pressure [ Time Frame: week 24 ]
  Examination by health professionals: blood pressure

Original Secondary Outcome:

• Antioxidant status [ Time Frame: at day one, week 12 and week 24 ]
  Blood specimen will be tested for glutathione (ox/red) levels.
• oxidative damage [ Time Frame: at day one, week 12 and week 24 ]
  Blood specimen will be tested for 8-OHdG, a marker for oxidative DNA damage.
• serum lipid levels [ Time Frame: at day one, week 12 and week 24 ]
  Serum will be analyzed for triglyceride, total cholesterol, HDL- and LDL-cholesterol.
• Lung inflammation test [ Time Frame: at day one, week 12 and week 24 ]
  Participants will exhale into a NIOX Mino device, which measures the nitric oxide level as marker of lung inflammation
• Health and compliance questionnaires [ Time Frame: weekly (compliance) and biweekly (health) for 6 months ]
  Health questionnaire (and initial sociodemographic questionnaire) will be filled in by participant every two weeks to assess overall health, and lentil consumption will be assessed weekly.
• Body mass index [ Time Frame: at day one, week 12 and week 24 ]
  Examination by health professionals: Body mass index
• Blood pressure [ Time Frame: at day one, week 12 and week 24 ]
  Examination by health professionals: blood pressure

Information By: University of Calgary

Dates:
Date Received: April 21, 2015
Date Started: October 2015
Date Completion:
Last Updated: March 29, 2017
Last Verified: March 2017