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Completed

NCT Number: NCT03412617

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

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.

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Key information

Conditions

Healthy Women Behavior Behavior, Animal Bifidobacterium Blood Glucose, High Body Weight Diet Habit Feeding Behavior Inflammation Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year–50 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Dietary or nutritional intake

    Time frame: September - November 2016

    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.

Secondary outcomes

  1. Total fecal microbiota

    Time frame: September - December 2016

    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.

  2. Weight

    Time frame: September - November 2016

    Body weight in kilograms

  3. Height

    Time frame: September - November 2016

    Height in metres

  4. Body mass index

    Time frame: September - November 2016

    Calculated from body weight divided by square of height, reported in kg/m2. Normal range 18.5-22.9 kg/m2.

  5. Obesity

    Time frame: September - November 2016

    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

  6. Waist circumference

    Time frame: September - November 2016

    Waist circumference in centimetres. Normal value is below 80 centimetres for women.

  7. Hip circumference

    Time frame: September - November 2016

    Hip circumference in centimetres

  8. Hemoglobin level

    Time frame: September - November 2016

    Blood hemoglobin was assessed by hemocue, reported in gram/decilitre. Normal value for blood hemoglobin is 12-15.5 gram/decilitre.

  9. HbA1c

    Time frame: September - November 2016

    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.

  10. Lipid profile

    Time frame: September - November 2016

    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).

  11. Fasting blood glucose

    Time frame: September - November 2016

    Fasting blood glucose was quantified using enzymatic colorimetric method glucose oxidase - phenol aminophenazone. Normal value is less than 100 milligrams/decilitre.

  12. Malondialdehyde (MDA) level

    Time frame: September - November 2016

    Blood MDA was quantified using spectrophotometry, reported in micromol/litre. There is no official cut off for this measurement.

  13. Total advanced glycation end products (AGE)

    Time frame: September - December 2016

    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.

  14. Plasma carboxymethyl lysine (CML)

    Time frame: July - December 2017

    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.

  15. Tumor necrosis factor-alfa (TNF-alfa)

    Time frame: July - December 2017

    Plasma tumor necrosis factor-alpha was done by ELISA, reported in IU/millilitre. There is no official cut off for this measurement.

Sponsors and collaborators

Lead sponsor

Rina Agustina

Other

Collaborators

  • Indonesia University
  • SEAMEO Regional Centre for Food and Nutrition

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Jan 26, 2018
Registry last updated
Jan 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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