High-selenium Lentils Versus Arsenic Toxicity
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|ClinicalTrials.gov Identifier: NCT02429921|
Recruitment Status : Completed
First Posted : April 29, 2015
Last Update Posted : March 31, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Arsenic Poisoning||Dietary Supplement: high-selenium lentils Dietary Supplement: Low-Se lentils||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Mitigating Arsenic Toxicity in Bangladeshi People by Supplementing Their Diets With High Selenium Lentils|
|Study Start Date :||October 2015|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||September 2016|
Experimental: low-Se lentils
50 mg of low-selenium lentils per person consumed as soups
Dietary Supplement: Low-Se lentils
lentils grown on selenium-deficient soils in Idaho, USA.
Other Name: low-selenium lentils
Experimental: high-Se lentils
50 mg of high-selenium lentils per person consumed as soup
Dietary Supplement: high-selenium lentils
lentils grown on naturally selenium-rich soils in the Canadian Prairies
- arsenic body burden [ Time Frame: week 12 ]Urine, feces, and hair samples of participants will be tested for arsenic content.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02429921
|Field Office, International Centre for Diarrhoeal Disease Research, Bangladesh|
|Dhaka, Bangladesh, 1212|
|Principal Investigator:||Judit EG Smits, DVM, PhD||University of Calgary, Calgary, Alberta, Canada|
|Study Director:||Albert Vandenberg, PhD||University of Saskatchewan|