NCT03882294

Probiotics and Its Associated Factors on Aflatoxin Biomarkers

Effect of Probiotics and Its Associated Factors on Aflatoxin Biomarkers Among Healthy Subjects in Serdang and Kajang, Selangor: A Twelve-week Intervention

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: Universiti Putra Malaysia · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The study will be aimed to investigate the effect of probiotic intervention and its associated factors on aflatoxin biomarkers among healthy subjects in Serdang and Kajang, Selangor

Detailed description

The study will be a randomized, double-blind, placebo-controlled, parallel intervention that conducted for 12 weeks and followed-up for 4 weeks among healthy adults under living condition in Serdang and Kajang, Selangor. 164 subjects will be recruited for the intervention study, where 82 subjects will be randomly allocated to the probiotic or placebo group. Probiotic and placebo drinks (80 ml) will be prepared in the form of bottle. Placebo drink will have similar taste, colour, physical appearance, and nutritional value as probiotic drink but contain no LcS. Morning urine samples (15 ml), weight status, and dietary intake will be collected every two weeks from week 0 to week 12 and follow up until week 16 at community centre. Whereas, fasting blood samples (5 ml) and physical activity will be collected every four weeks for 16 weeks at the community centre.

Conditions

• Aflatoxicosis

Interventions

Type	Name	Description
OTHER	Probiotics	Participants will be requested to consume the drinks (80 ml) twice a day - after lunch and dinner for 12 weeks.
OTHER	Placebo	Participants will be requested to consume the drinks (80 ml) twice a day - after lunch and dinner for 12 weeks.

Timeline

• Start date: 2020-09-11
• Primary completion: 2021-10-31
• Completion: 2021-10-31
• First posted: 2019-03-20
• Last updated: 2022-06-21

Locations

1 site across 1 country: Malaysia