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

NCT03412617 | Completed

• 1 other identifier: Dietary Minangkabau-Sunda
• Study Type: observational
• Target: 360
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Healthy Eating; Blood glucose; Bifidobacterium; Obese women

Outcome Measures

Primary Outcomes (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.

  September - November 2016

Secondary Outcomes (15)

• Total fecal microbiota

  September - December 2016

• Weight

  September - November 2016

• Height

  September - November 2016

• Body mass index

  September - November 2016

• Obesity

  September - November 2016

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rina Agustina: lead
• SEAMEO Regional Centre for Food and Nutrition: collaborator
• Indonesia University: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and feces

MeSH Terms

Conditions

Feeding Behavior; Inflammation; Obesity

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Study Officials

• Rina Agustina

  Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, MSc, PhD

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: January 26, 2018
• Study Start: August 22, 2016
• Primary Completion: November 16, 2016
• Study Completion: December 20, 2017
• Last Updated: January 30, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share