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

NCT ID: NCT03412617

Last Updated: 2018-01-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 360 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-08-22
• Study Completion Date: 2017-12-20

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.

Conditions

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

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: CROSS_SECTIONAL

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

SEAMEO Regional Centre for Food and Nutrition

OTHER

Sponsor Role: collaborator

Indonesia University

OTHER

Sponsor Role: collaborator

Rina Agustina

OTHER

Sponsor Role: lead

Responsible Party

Rina Agustina

MD, MSc, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Rina Agustina

Role: PRINCIPAL_INVESTIGATOR

Indonesia University

Other Identifiers

Dietary Minangkabau-Sunda

Identifier Type: -

Identifier Source: org_study_id