Clinical trial NCT03412617: Diets, Metabolic Profile and Gut Microbiota Among Indonesian Women in Minangkabau and Sundanese-ethnic Community
Official title: Association of Intake and Nutritional Status With Total Microbiota and Metabolic Marker in Minangkabau and Sundanese Women in Urban and City: A Comparative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Women
Diet Habit
Bifidobacterium
Inflammation
Obesity
Blood Glucose, High
Keywords: Healthy Eating
Blood glucose
Bifidobacterium
Obese women
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: SEAMEO Regional Centre for Food and Nutrition
name: Indonesia University
First posted: 2018-01-26
Enrollment: 360
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Population represent mountainous and coastal areas (Tanah Datar and Padang Pariaman districts in West Sumatera for the Minangkabau ethnic group, and Tasikmalaya District in West Java for the Sundanese ethnic group), who are known to have differences in their traditional diets. These areas have agricultural fields, and the population of farmers and fishermen is above the regional average.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Dietary or nutritional intake
timeFrame: September - November 2016
Secondary outcomes:
measure: Total fecal microbiota
timeFrame: September - December 2016
measure: Weight
timeFrame: September - November 2016
measure: Height
timeFrame: September - November 2016
measure: Body mass index
timeFrame: September - November 2016
measure: Obesity
timeFrame: September - November 2016
measure: Waist circumference
timeFrame: September - November 2016
measure: Hip circumference
timeFrame: September - November 2016
measure: Hemoglobin level
timeFrame: September - November 2016
measure: HbA1c
timeFrame: September - November 2016
measure: Lipid profile
timeFrame: September - November 2016
measure: Fasting blood glucose
timeFrame: September - November 2016
measure: Malondialdehyde (MDA) level
timeFrame: September - November 2016
measure: Total advanced glycation end products (AGE)
timeFrame: September - December 2016
measure: Plasma carboxymethyl lysine (CML)
timeFrame: July - December 2017
measure: Tumor necrosis factor-alfa (TNF-alfa)
timeFrame: July - December 2017
Other outcomes:
Locations:
Study officials:
affiliation: Indonesia University
name: Rina Agustina
role: PRINCIPAL_INVESTIGATOR
References: