An interventional study of Probiotics and Placebo in Aflatoxicosis, sponsored by Universiti Putra Malaysia. Completed at 1 site in Malaysia. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-21.
Sponsored by Universiti Putra Malaysia · Not applicable, Interventional, and Prevention
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
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.
Universiti Putra Malaysia is the lead sponsor of 144 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects in probiotic group will receive fermented milk containing live cultures Lactobacillus casei Shirota (LcS), 3 x 10\^10 CFU/bottle (80 ml)
Other: Probiotics
Subjects in placebo group will receive milk drink without LcS (80 ml).
Other: Placebo
Participants will be requested to consume the drinks (80 ml) twice a day - after lunch and dinner for 12 weeks.
Participants will be requested to consume the drinks (80 ml) twice a day - after lunch and dinner for 12 weeks.
Changes in serum AFB1-lysine adducts (pg/mg albumin) over 16 weeks
Analysis of serum AFB1-lysine adducts will be done using elisa kit through HPLC.
Time frame: From week 0 to week 16
Changes in urinary AFM1 (ng/ml) over 16 weeks
Analysis of urinary AFM1 will be done using elisa kit.
Time frame: From week 0 to week 16
Changes in body mass index (kg/m^2) over 16 weeks
Changes in weight and height will be measured using weighing scale and body meter respectively. Weight and height will be combined to report BMI in kg/m\^2
Time frame: From week 0 to week 16
Changes in waist circumference (cm) over 16 weeks
The parameter will be measured using measuring tape.
Time frame: From week 0 to week 16
Changes in physical activity level (MET-min/week) over 16 weeks
The parameter will be examined using questionnaire based on the Global Physical Activity Questionnaire.
Time frame: From week 0 to week 16
Changes in dietary intake over 16 weeks
Dietary assessment will be recorded via food frequency questionnaire (FFQ). The conversion of food frequency to the amount of food intake is carried out using the following formula: Amount of food (g/day) = frequency of intake (conversion factor) × serving size × total of serving × weight of food in one serving (Wessex Institute of Public Health, 1995).
Time frame: From week 0 to week 16
Changes in knowledge, attitude and practice (KAP) on aflatoxin over 16 weeks
KAP will be examined using questionnaire in bilingual (English and Bahasa Malaysia). Knowledge towards aflatoxin is scored into two groups: know and do not know. Attitudes and practices are categorized using likert scale with 1=strongly disagree, 2=disagree, 3=agree and 4=strongly agree.
Time frame: From week 0 to week 16
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Aflatoxin Poisoning
Universiti Putra Malaysia