NCT03412617

Diets, Metabolic Profile and Gut Microbiota Among Indonesian Women in Minangkabau and Sundanese-ethnic Community

Association of Intake and Nutritional Status With Total Microbiota and Metabolic Marker in Minangkabau and Sundanese Women in Urban and City: A Comparative Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 360 (actual)
• Sponsor: Rina Agustina · Academic / Other
• Sex: Female
• Age: 19 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy Women
• Diet Habit
• Bifidobacterium
• Inflammation
• Obesity
• Blood Glucose, High

Timeline

• Start date: 2016-08-22
• Primary completion: 2016-11-16
• Completion: 2017-12-20
• First posted: 2018-01-26
• Last updated: 2018-01-30