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Healthy WomenNCT03412617

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

An observational study of Healthy Women and Diet Habit, run by Rina Agustina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 19 to 50 years, women only
Conditions the study is for
Healthy Women, Diet Habit, Bifidobacterium
How many people
360 participants
Where
No sites listed yet
Study dates
22 Aug 2016to 20 Dec 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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

About this study

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

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.

Read the 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.

Keywords
Healthy Eating, Blood glucose, Bifidobacterium, Obese women
Medical subject headings
Feeding Behavior, Inflammation, Obesity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: September - November 2016

Secondary outcomes (15)

  1. 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.

    Measured: September - December 2016

  2. Weight

    Body weight in kilograms

    Measured: September - November 2016

  3. Height

    Height in metres

    Measured: September - November 2016

  4. Body mass index

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

    Measured: September - November 2016

  5. 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

    Measured: September - November 2016

  6. Waist circumference

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

    Measured: September - November 2016

  7. Hip circumference

    Hip circumference in centimetres

    Measured: September - November 2016

  8. Hemoglobin level

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

    Measured: September - November 2016

  9. 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.

    Measured: September - November 2016

  10. 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).

    Measured: September - November 2016

  11. Fasting blood glucose

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

    Measured: September - November 2016

  12. Malondialdehyde (MDA) level

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

    Measured: September - November 2016

  13. 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.

    Measured: September - December 2016

  14. 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.

    Measured: July - December 2017

  15. 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.

    Measured: July - December 2017

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2018
  2. Study start22 Aug 2016
  3. Primary completion16 Nov 2016
  4. Study completion20 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrolment
360 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03412617
Sponsor's protocol ID
Dietary Minangkabau-Sunda
Status last verified
Jan 2018
First submitted
11 Jan 2018
Last updated
30 Jan 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy Women and Diet Habit, run by Rina Agustina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dietary or nutritional intake (time frame: September - November 2016). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03412617.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2018.

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