Association of Intake and Nutritional Status With Total Microbiota and Metabolic Marker in Minangkabau and Sundanese Women in Urban and City: A Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 360
- 主要终点
- Dietary or nutritional intake
研究概览
简要总结
Many provinces in Indonesia have some well known traditional foods that are widely consumed, but it remains unknown whether traditional ethnic dietary patterns can confirm healthy diets. High quality diet is associated with reduced risk of metabolic diseases and modulated gut microbiota. Moreover, the relationship between dietary quality and microbiota, a potential mediator of metabolic disease, has not been studied.
详细描述
This study was conducted in specific villages and hamlets that were randomly selected by multi-stage random cluster sampling in 2 provinces. The investigators randomly selected 36 villages (18 villages in each provinces) by using probability proportional to size cluster sampling to admit the total 360 women who met the criteria and consented. While Bifidobacterium, Advanced Glycation End Products (AGE) and lipid profile were examined in a subgroup of 120 participants from each province (n=240).
Field enumerators were trained to standardize 24 hours food recall, food frequency questionnaire for 1 month back, and for stool sampling technique procedure.
Anthropometric measurement was performed by performing weight and height measurement. Fasting blood sampling and fecal Bifidobacterium examination were done in collaboration with professional laboratories. Hemoglobin was assessed by using hemocue. Lipid profile was quantified using calorimetric method, fasting blood glucose (FBG) was quantified using enzymatic colorimetric method glucose oxidase - phenol aminophenazone, HbA1c was using high performance liquid chromatography (HPLC) hexokinase, malondialdehyde level was quantified using will's spectrophotometry, blood advance glycation end products was done by using enzyme linked immunosorbent assay (ELISA), carboxymethyl lysine plasma was done by ultra performance liquid chromatography-tandem mass spectometry (UPLC-MS/MS), and plasma tumor necrosis factor-alpha was done by ELISA. Fecal sample were collected in 2 pots, each contain 5-10 gram of stool, and store in cooler box (2-9 degree celcius) until sample was transported to laboratory as soon as possible to store in -80 degree celcius freezer.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •healthy reproductive women aged 19-50 years old
- •having both parents from the same ethnicities (Minangkabau or Sundanese)
- •willing to participate voluntarily signed a written informed-consent.
排除标准
- •not being pregnant or lactating
- •not having symptoms of gastrointestinal disturbance such as diarrhea, dysentery, constipation more than 3 days, and/or abdominal pain for the last 2 weeks
- •not having nausea or vomiting or lost appetite for the last 2 days
- •no history of malignancy
- •not consuming antibiotics in the last 1 week before fecal collection
- •not consuming alcohol more than 3 times a week
结局指标
主要结局
Dietary or nutritional intake
时间窗: September - November 2016
Usual dietary intake was done by using semi quantitative food frequency questionnaire for 1 month, and actual intake was done by nonconsecutive repeated 24-hour food recall (weekday and weekend). The investigators was analyse the dietary intake by Nutrisurvey 2007 software. Nutritional intake was reported as total daily intake (energy, macronutrients, and micronutrients). Energy intake is showed in kkal/day. Macronutrients include carbohydrate, protein, fat, and fiber intake are showed in gram/day. Micronutrients include vitamins and minerals are showed in gram/milligram/microgram per day. The value of nutrient intake are very diverse from 0 to high intake.
次要结局
- Weight(September - November 2016)
- Fasting blood glucose(September - November 2016)
- Plasma carboxymethyl lysine (CML)(July - December 2017)
- Tumor necrosis factor-alfa (TNF-alfa)(July - December 2017)
- Waist circumference(September - November 2016)
- Hip circumference(September - November 2016)
- Body mass index(September - November 2016)
- Total fecal microbiota(September - December 2016)
- Height(September - November 2016)
- Lipid profile(September - November 2016)
- Hemoglobin level(September - November 2016)
- Obesity(September - November 2016)
- HbA1c(September - November 2016)
- Total advanced glycation end products (AGE)(September - December 2016)
- Malondialdehyde (MDA) level(September - November 2016)
研究者
Rina Agustina
MD, MSc, PhD
Indonesia University