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

NCT07170904 | Recruiting

• 2 other identifiers: DIVERSE (Protocol # KET-1848)NKB-298/UN2.RST/HKP.05.00/2024
• Study Type: observational
• Target: 188
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Body Composition; Zinc Status; Dietary Analysis; TNF Alpha; Blood Pressure

Keywords

women of reproductive age; dietary assessment; hair zinc; TNF alpha; body composition; blood pressure; BOD POD

Outcome Measures

Primary Outcomes (7)

• Dietary Zinc Intake

  Average daily zinc intake (mg/day) will be assessed using two dietary assessment methods: a Semi-Quantitative Food Frequency Questionnaire (SQ-FFQ) and multiple-day Food Records. For women aged 19 to 49 years, the Recommended Dietary Allowance (RDA) is 8 mg/day, the Estimated Average Requirement (EAR) is 6.8 mg/day, and the Tolerable Upper Intake Level (UL) is 40 mg/day. Higher or lower values will be interpreted relative to these reference standards.

  At baseline (single assessment)

• Diet Quality Assessed by HEI-2020

  The Healthy Eating Index-2020 (HEI-2020) is a measure of diet quality that assesses conformance to the 2020-2025 Dietary Guidelines for Americans. The score ranges from 0 to 100, with higher scores indicating better adherence and higher diet quality.

  Baseline (cross-sectional assessment at enrollment)

• Planetary Health Diet Index (PHDI)

  The Planetary Health Diet (PHD), proposed by the EAT-Lancet Commission, is a dietary pattern designed to promote human health and environmental sustainability. The Planetary Health Diet Index (PHDI) is a scoring system (range: 0-150) that measures adherence to the PHD, with higher scores indicating greater adherence.

  Baseline (cross-sectional data collection)

• Ultra-Processed Food (UPF) intake

  UPF intake will be estimated using the NOVA classification, expressed as percentage of total energy intake (%TEI). Higher percentages indicate worse outcome (poorer diet quality due to higher UPF intake).

  Baseline (cross-sectional data collection)

• Body Composition (Fat Mass, Fat-Free Mass)

  Measured using BOD POD to determine body fat percentage, fat mass, and fat-free mass

  At baseline (single assessment)

• Hair Zinc Concentration

  Zinc concentration measured from hair samples as an indicator of long-term zinc status

  At baseline (single assessment)

• Blood Pressure

  Systolic and diastolic blood pressure are measured to assess cardiovascular health status

  At baseline (single assessment)

Secondary Outcomes (1)

• Inflammatory Biomarker Levels (TNF-α in Serum)

  At baseline (single assessment)

Study Arms (1)

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.

Other: Not applicable- observational study

Interventions

Not applicable- observational study OTHER

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

Women of Reproductive Age (WRA) Participants

Eligibility Criteria

• Age: 19 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Women of reproductive age (19-49 years) living in Jakarta, Indonesia, from five major ethnic groups (Minangkabau, Sundanese, Javanese, Betawi, and Chinese), recruited from community settings.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

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

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

RECRUITING

Related Publications (6)

• 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.

  PMID: 40894483 BACKGROUND

• 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.

  PMID: 21892588 BACKGROUND

• 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.

  PMID: 35187040 BACKGROUND

• 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.

  PMID: 30767573 BACKGROUND

• 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.

  PMID: 31323812 BACKGROUND

• 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.

  PMID: 37460680 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples retained for analysis only (no future use). Venous blood samples will be collected for the quantification of TNF-α, and hair samples will be obtained for the determination of zinc concentration. Samples will not be stored for future research use.

Study Officials

• Rina Agustina, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dhani Latifani, BSc, MSc

CONTACT

+6285868975494; dhanilatifani94@gmail.com

Ana D Sakinah, BApp.Sc

CONTACT

+6282219194716; anadinasakinah@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Nutrition, Faculty of Medicine, Universitas Indonesia

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 12, 2025
• Study Start: February 3, 2025
• Primary Completion: December 30, 2025
• Study Completion: March 31, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)