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

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Obesity; Diet Habit; Healthy Women; Blood Glucose, High; Bifidobacterium

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.

• Study Type: Observational
• Enrollment (Actual): 360

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary or nutritional intake	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.	September - November 2016

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total fecal microbiota	Microbiota that examined in this study was total Bifidobacterium, quantified by real time-polymerase chain reaction, reported as log Bifidobacterium/gram feces. There is no official cut off for this measurement.	September - December 2016
Weight	Body weight in kilograms	September - November 2016
Height	Height in metres	September - November 2016
Body mass index	Calculated from body weight divided by square of height, reported in kg/m2. Normal range 18.5-22.9 kg/m2.	September - November 2016
Obesity	Classified using body mass index Asia Pacific standard. Score body mass index below 18.5 kg/m2 is underweight, 18.5-22.9 kg/m2 is normal range, 23-24.9 kg/m2 is overweight, 25-29.9 kg/m2 is obese 1, higher than 30 kg/m2 is obese 2	September - November 2016
Waist circumference	Waist circumference in centimetres. Normal value is below 80 centimetres for women.	September - November 2016
Hip circumference	Hip circumference in centimetres	September - November 2016
Hemoglobin level	Blood hemoglobin was assessed by hemocue, reported in gram/decilitre. Normal value for blood hemoglobin is 12-15.5 gram/decilitre.	September - November 2016
HbA1c	HbA1c was quantified using high performance liquid chromatography (HPLC) hexokinase, reported in %. Normal value is 4%-5.6%. Score 5.7%-6.4% means high risk of diabetes. Score 6.5% or higher for diagnose diabetes.	September - November 2016
Lipid profile	Blood lipid profile was quantified using calorimetric method, reported as cholesterol total (normal value is less than 200 milligrams/decilitre)/ low density lipoprotein cholesterol (normal value is less than 100 milligrams/decilitre)/ high density lipoprotein cholesterol (normal value is higher than 40 milligrams/decilitre)/ triglyceride (normal value is less than 150 milligrams/decilitres).	September - November 2016
Fasting blood glucose	Fasting blood glucose was quantified using enzymatic colorimetric method glucose oxidase - phenol aminophenazone. Normal value is less than 100 milligrams/decilitre.	September - November 2016
Malondialdehyde (MDA) level	Blood MDA was quantified using spectrophotometry, reported in micromol/litre. There is no official cut off for this measurement.	September - November 2016
Total advanced glycation end products (AGE)	Blood AGE was quantified by using enzyme linked immunosorbent assay (ELISA), reported in kilo unit/millilitre. There is no official cut off for this measurement.	September - December 2016
Plasma carboxymethyl lysine (CML)	Plasma CML was quantified by ultra performance liquid chromatography-tandem mass spectometry (UPLC-MS/MS), reported in nanograms/millilitre. There is no official cut off for this measurement.	July - December 2017
Tumor necrosis factor-alfa (TNF-alfa)	Plasma tumor necrosis factor-alpha was done by ELISA, reported in IU/millilitre. There is no official cut off for this measurement.	July - December 2017

Collaborators and Investigators

• Sponsor: Rina Agustina
• Collaborators: Indonesia University; SEAMEO Regional Centre for Food and Nutrition
• Investigators: Principal Investigator: Rina Agustina, Indonesia University

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2016
• Primary Completion (Actual): November 16, 2016
• Study Completion (Actual): December 20, 2017

Study Registration Dates

• First Submitted: January 11, 2018
• First Submitted That Met QC Criteria: January 19, 2018
• First Posted (Actual): January 26, 2018

Study Record Updates

• Last Update Posted (Actual): January 30, 2018
• Last Update Submitted That Met QC Criteria: January 26, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Bifidobacterium; Obese women; Blood glucose; Healthy Eating
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: Dietary Minangkabau-Sunda

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No