Dietary Patterns, Inflammation, Zinc Status, and Body Composition in Multi-Ethnic Women of Reproductive Age in Jakarta

NCT ID: NCT07170904

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

188 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-03

Study Completion Date

2026-03-31

Brief Summary

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This study aims to determine the relationship between dietary patterns and hair zinc levels with body composition, tumor necrosis factor alpha (TNF-α), and blood pressure in women of reproductive age from different ethnic backgrounds in Jakarta, Indonesia (specifically Minangkabau, Sundanese, Javanese, Betawi, and Chinese). Participants are assessed once through dietary assessment, anthropometric measurements, and biological sample collection.

Detailed Description

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This cross-sectional observational study will evaluate dietary patterns and their association with nutritional status and inflammation in women of reproductive age. Participants will undergo dietary intake assessments (including the SQ-FFQ and a 3-day food diary), anthropometric and body composition measurements using the BOD POD (weight, height, fat mass, fat-free mass), and biospecimen sampling (blood and hair) for laboratory analysis of TNF-α and hair zinc concentrations. These findings are expected to offer information about dietary determinants and zinc micronutrient status that influence body composition, inflammation, and blood pressure in urban reproductive-age women from diverse ethnic backgrounds.

Conditions

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TNF Alpha Body Composition Zinc Status Dietary Analysis Blood Pressure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Women of Reproductive Age (WRA) Participants

A single group of women aged 19-49 years residing in Jakarta, Indonesia, from multi-ethnic backgrounds (Minangkabau, Sundanese, Javanese, Betawi, and Chinese). Participants undergo dietary assessment, body composition measurement using BOD POD, blood pressure measurement, and collection of hair and blood samples for zinc and TNF-α analysis.

Not applicable- observational study

Intervention Type OTHER

This is an observational study; no interventions are administered to participants.

Interventions

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Not applicable- observational study

This is an observational study; no interventions are administered to participants.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Women aged 19-49 years
* Residing in Jakarta for at least 6 months
* Currently menstruating (not menopausal)
* From Minangkabau, Sundanese, Javanese, Betawi, or Chinese ethnicity
* Not pregnant or breastfeeding at the time of study

Exclusion Criteria

* History of chronic diseases (e.g., diabetes, cardiovascular disease, cancer)
* Currently on a medically prescribed diet or taking medication affecting nutrient status
* Any condition interfering with accurate body composition measurement
Minimum Eligible Age

19 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Prof Rina Agustina, MD, PhD

Professor of Nutrition, Faculty of Medicine, Universitas Indonesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rina Agustina, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dep of Nutrition, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia

Locations

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Human Nutrition Research Center (HNRC) Laboratory, IMERI, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia

Jakarta Pusat, DKI Jakarta, Indonesia

Site Status RECRUITING

Countries

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Indonesia

Central Contacts

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Dhani Latifani, BSc, MSc

Role: CONTACT

+6285868975494

Ana D Sakinah, BApp.Sc

Role: CONTACT

+6282219194716

Facility Contacts

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Dhani Latifani, B.Sc, M.Sc

Role: primary

+6285868975494

Amalia Chairunnisa, B.App.Sc

Role: backup

+6281317623966

References

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Lee J, Chae J, Kim M, Jung SY, Yoo SD, Kang SH, Lee K, Kim JH. Association of body composition and cardiovascular fitness with hypertension in a middle-aged adults: a cross-sectional study. Front Cardiovasc Med. 2025 Aug 14;12:1582936. doi: 10.3389/fcvm.2025.1582936. eCollection 2025.

Reference Type BACKGROUND
PMID: 40894483 (View on PubMed)

Ennes Dourado Ferro F, de Sousa Lima VB, Mello Soares NR, Franciscato Cozzolino SM, do Nascimento Marreiro D. Biomarkers of metabolic syndrome and its relationship with the zinc nutritional status in obese women. Nutr Hosp. 2011 May-Jun;26(3):650-4. doi: 10.1590/S0212-16112011000300032.

Reference Type BACKGROUND
PMID: 21892588 (View on PubMed)

Ding J, Liu Q, Liu Z, Guo H, Liang J, Zhang Y. Association Between Dietary Zinc Intake and Metabolic Syndrome. A Meta-Analysis of Observational Studies. Front Nutr. 2022 Feb 3;9:825913. doi: 10.3389/fnut.2022.825913. eCollection 2022.

Reference Type BACKGROUND
PMID: 35187040 (View on PubMed)

Pettersson-Pablo P, Nilsson TK, Breimer LH, Hurtig-Wennlof A. Body fat percentage is more strongly associated with biomarkers of low-grade inflammation than traditional cardiometabolic risk factors in healthy young adults - the Lifestyle, Biomarkers, and Atherosclerosis study. Scand J Clin Lab Invest. 2019 May;79(3):182-187. doi: 10.1080/00365513.2019.1576219. Epub 2019 Feb 15.

Reference Type BACKGROUND
PMID: 30767573 (View on PubMed)

Jayasinghe SN, Breier BH, McNaughton SA, Russell AP, Della Gatta PA, Mason S, Stonehouse W, Walsh DCI, Kruger R. Dietary Patterns in New Zealand Women: Evaluating Differences in Body Composition and Metabolic Biomarkers. Nutrients. 2019 Jul 18;11(7):1643. doi: 10.3390/nu11071643.

Reference Type BACKGROUND
PMID: 31323812 (View on PubMed)

Carter JL, Abdullah N, Bragg F, Murad NAA, Taylor H, Fong CS, Lacey B, Sherliker P, Karpe F, Mustafa N, Lewington S, Jamal R. Body composition and risk factors for cardiovascular disease in global multi-ethnic populations. Int J Obes (Lond). 2023 Sep;47(9):855-864. doi: 10.1038/s41366-023-01339-9. Epub 2023 Jul 17.

Reference Type BACKGROUND
PMID: 37460680 (View on PubMed)

Other Identifiers

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NKB-298/UN2.RST/HKP.05.00/2024

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

DIVERSE (Protocol # KET-1848)

Identifier Type: -

Identifier Source: org_study_id

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