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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics | Experimental | Subjects in probiotic group will receive fermented milk containing live cultures Lactobacillus casei Shirota (LcS), 3 x 10^10 CFU/bottle (80 ml) |
|
| Placebo | Placebo Comparator | Subjects in placebo group will receive milk drink without LcS (80 ml). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotics | Other | Participants will be requested to consume the drinks (80 ml) twice a day - after lunch and dinner for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | From week 0 to week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From week 0 to week 16 |
| Changes in waist circumference (cm) over 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Assoc Prof Dr Rosita Jamaluddin | Universiti Putra Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teaching Hospital Universiti Putra Malaysia | Serdang | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40250564 | Derived | Chang WL, Akiyama T, Wang JS, Yong HY, Hassan F, Abu Saad H, Jamaluddin R, Sabran MR. Impact of Probiotic Lacticaseibacillus paracasei Strain Shirota (LcS) on Aflatoxin Exposure among Healthy Malaysian Adults: A Randomized, Double-Blind, Placebo-Controlled Intervention Study. J Nutr. 2025 Jul;155(7):2110-2121. doi: 10.1016/j.tjnut.2025.04.014. Epub 2025 Apr 16. |
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| ID | Term |
|---|---|
| D000096702 | Aflatoxin Poisoning |
| ID | Term |
|---|---|
| D015651 | Mycotoxicosis |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Randomized , double-blind, placebo-controlled, parallel trial
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Participants, care provider, and investigators will be blinded for the treatment assignment. A controller will be recruited to determine the two groups into probiotic and placebo groups.
| Placebo | Other | Participants will be requested to consume the drinks (80 ml) twice a day - after lunch and dinner for 12 weeks. |
|
The parameter will be measured using measuring tape. |
| 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. | 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). | 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. | From week 0 to week 16 |
| D019602 |
| Food and Beverages |