Probiotics and Its Associated Factors on Aflatoxin Biomarkers

Aflatoxicosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03882294
• Other study ID #: PRO001
• Status: Completed
• Phase: N/A
• Start date: September 11, 2020
• Est. completion date: October 31, 2021

Study information

• Verified date: June 2022
• Source: Universiti Putra Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• Malaysian healthy male or female adults (BMI <30kg/m2) aged 20 to 60 years who have regular bowel movement (at least 4 times/week), AFB1 >4.71 pg/mg albumin, and AFM1 > 0.88 ng/ml

Exclusion Criteria:

1. History or presence of any clinically important disease or disorder (eg. cardiovascular disease, kidney disease, diabetes mellitus, etc.) which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study

2. Mental status that is incompatible with the proper conduct of the study

3. Functional constipation [based on Rome III diagnostic criteria with a five-point symptoms based diagnosing tool (0=never or rarely, 1=sometimes, 2=often, 3=most of the time, 4=always)]

4. Diarrhoea within 2 months prior to the study start

5. Allergic reaction towards probiotic, milk and with gastric problem

6. Lactose intolerance

7. Use of medications or/and antibiotics

8. Use of probiotic, prebiotic and fibre supplements or/and laxatives during the two weeks prior to study start.

9. Drug/alcohol abuse (for alcohol 4 times/day or 20 times/week)

10. Pregnant

11. Reported special diets such as vegetarian, vegan, or macrobiotic

12. Festive (eg. Ramadan, Chinese New Year etc) 3 months before and during the study

13. Participation in another intervention study one month prior to the present study

Related Conditions & MeSH terms

• Aflatoxicosis

Intervention

Other:
• Probiotics
Participants will be requested to consume the drinks (80 ml) twice a day - after lunch and dinner for 12 weeks.
• Placebo
Participants will be requested to consume the drinks (80 ml) twice a day - after lunch and dinner for 12 weeks.

Locations

Country	Name	City	State
Malaysia	Teaching Hospital Universiti Putra Malaysia	Serdang

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Putra Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	Changes in waist circumference (cm) over 16 weeks	The parameter will be measured using measuring tape.	From week 0 to week 16
Secondary	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
Secondary	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
Secondary	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