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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03412617
Enrollment
360
Registered
2018-01-26
Start date
2016-08-22
Completion date
2017-12-20
Last updated
2018-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Healthy Eating, Blood glucose, Bifidobacterium, Obese women

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.

Interventions

None listed

Sponsors

SEAMEO Regional Centre for Food and Nutrition
CollaboratorOTHER
Indonesia University
CollaboratorOTHER
Rina Agustina
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Dietary or nutritional intakeSeptember - November 2016Usual 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.

Secondary

MeasureTime frameDescription
Hemoglobin levelSeptember - November 2016Blood hemoglobin was assessed by hemocue, reported in gram/decilitre. Normal value for blood hemoglobin is 12-15.5 gram/decilitre.
Total fecal microbiotaSeptember - December 2016Microbiota 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.
WeightSeptember - November 2016Body weight in kilograms
HeightSeptember - November 2016Height in metres
Body mass indexSeptember - November 2016Calculated from body weight divided by square of height, reported in kg/m2. Normal range 18.5-22.9 kg/m2.
ObesitySeptember - November 2016Classified 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
Waist circumferenceSeptember - November 2016Waist circumference in centimetres. Normal value is below 80 centimetres for women.
Hip circumferenceSeptember - November 2016Hip circumference in centimetres
Lipid profileSeptember - November 2016Blood 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).
Fasting blood glucoseSeptember - November 2016Fasting blood glucose was quantified using enzymatic colorimetric method glucose oxidase - phenol aminophenazone. Normal value is less than 100 milligrams/decilitre.
Malondialdehyde (MDA) levelSeptember - November 2016Blood MDA was quantified using spectrophotometry, reported in micromol/litre. There is no official cut off for this measurement.
Total advanced glycation end products (AGE)September - December 2016Blood AGE was quantified by using enzyme linked immunosorbent assay (ELISA), reported in kilo unit/millilitre. There is no official cut off for this measurement.
Plasma carboxymethyl lysine (CML)July - December 2017Plasma 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.
Tumor necrosis factor-alfa (TNF-alfa)July - December 2017Plasma tumor necrosis factor-alpha was done by ELISA, reported in IU/millilitre. There is no official cut off for this measurement.
HbA1cSeptember - November 2016HbA1c 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026