Effect of Probiotics and Its Associated Factors on Aflatoxin Biomarkers Among Healthy Subjects in Serdang and Kajang, Selangor: A Twelve-week Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Changes in serum AFB1-lysine adducts (pg/mg albumin) over 16 weeks
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •Mental status that is incompatible with the proper conduct of the study
- •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)]
- •Diarrhoea within 2 months prior to the study start
- •Allergic reaction towards probiotic, milk and with gastric problem
- •Lactose intolerance
- •Use of medications or/and antibiotics
- •Use of probiotic, prebiotic and fibre supplements or/and laxatives during the two weeks prior to study start.
- •Drug/alcohol abuse (for alcohol 4 times/day or 20 times/week)
- •Reported special diets such as vegetarian, vegan, or macrobiotic
- •Festive (eg. Ramadan, Chinese New Year etc) 3 months before and during the study
- •Participation in another intervention study one month prior to the present study
结局指标
主要结局
Changes in serum AFB1-lysine adducts (pg/mg albumin) over 16 weeks
时间窗: From week 0 to week 16
Analysis of serum AFB1-lysine adducts will be done using elisa kit through HPLC.
Changes in urinary AFM1 (ng/ml) over 16 weeks
时间窗: From week 0 to week 16
Analysis of urinary AFM1 will be done using elisa kit.
次要结局
- Changes in body mass index (kg/m^2) over 16 weeks(From week 0 to week 16)
- Changes in waist circumference (cm) over 16 weeks(From week 0 to week 16)
- Changes in dietary intake over 16 weeks(From week 0 to week 16)
- Changes in knowledge, attitude and practice (KAP) on aflatoxin over 16 weeks(From week 0 to week 16)
- Changes in physical activity level (MET-min/week) over 16 weeks(From week 0 to week 16)
研究者
Assoc. Prof. Dr. Rosita Jamaluddin
Associate Professor
Universiti Putra Malaysia