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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03412617
• Other study ID #: Dietary Minangkabau-Sunda
• Status: Completed
• Phase: N/A
• First received: January 11, 2018
• Last updated: January 26, 2018
• Start date: August 22, 2016
• Est. completion date: December 20, 2017

Study information

• Verified date: January 2018
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: December 20, 2017
• Est. primary completion date: November 16, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Rina Agustina	Indonesia University, SEAMEO Regional Centre for Food and Nutrition

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Weight	Body weight in kilograms	September - November 2016
Secondary	Height	Height in metres	September - November 2016
Secondary	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
Secondary	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
Secondary	Waist circumference	Waist circumference in centimetres. Normal value is below 80 centimetres for women.	September - November 2016
Secondary	Hip circumference	Hip circumference in centimetres	September - November 2016
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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