Body CompositionDIVERSENCT07170904
Dietary Patterns, Inflammation, Zinc Status, and Body Composition in Multi-Ethnic Women of Reproductive Age in Jakarta
An observational study of Body Composition and Zinc Status, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Body Composition, Zinc Status, Dietary Analysis
- What is being tested?
- Not applicable- observational study
- How many people
- 188 participants
- Where
- 1 siteIndonesia
- Study dates
- 3 Feb 2025to 31 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 49 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site, 1 recruiting
- Recruiting
Human Nutrition Research Center (HNRC) Laboratory, IMERI, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia
Jakarta Pusat, DKI Jakarta, 10430
Dhani Latifani, B.Sc, M.Sc, +6285868975494, dhanilatifani94@gmail.com
Amalia Chairunnisa, B.App.Sc, +6281317623966, achairunnisa@gmail.com
About this study
Official title: The Relationship Between Dietary Patterns and Hair Zinc Levels With Body Composition, TNF-α, and Blood Pressure in Women of Reproductive Age (WRA) With Multi-Ethnicities in Jakarta: A Cross-Sectional Study
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.
Read the detailed description
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
- Body Composition, Zinc Status, Dietary Analysis, TNF Alpha, Blood Pressure
- Being tested
- Not applicable- observational study
- Keywords
- women of reproductive age, dietary assessment, hair zinc, TNF alpha, body composition, blood pressure, BOD POD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable- observational studyOther
This is an observational study; no interventions are administered to participants.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Not applicable- observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: At baseline (single assessment)
Hair Zinc Concentration
Zinc concentration measured from hair samples as an indicator of long-term zinc status
Measured: At baseline (single assessment)
Blood Pressure
Systolic and diastolic blood pressure are measured to assess cardiovascular health status
Measured: At baseline (single assessment)
Secondary outcomes (1)
Inflammatory Biomarker Levels (TNF-α in Serum)
Serum TNF-α measured as a marker of inflammation, assessed in approximately 30% of total participants (sub-sample)
Measured: At baseline (single assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start3 Feb 2025
- Primary completion30 Dec 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Body CompositionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Rina Agustina, MD, PhD, Universitas Indonesia
- Investigators
- Rina Agustina, MD, PhD, Principal investigator, Dep of Nutrition, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07170904
- Sponsor's protocol ID
- DIVERSE (Protocol # KET-1848)
- Other IDs
- NKB-298/UN2.RST/HKP.05.00/2024
- Acronym
- DIVERSE
- Status last verified
- Nov 2025
- First submitted
- 5 Sep 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share Individual Participant Data (IPD). Data transfer to any third party will adhere to the ethical principles of the Declaration of Helsinki and comply with university regulations and the laws of the Republic of Indonesia, thereby upholding the rights of patients/subjects.
Publications
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.
PubMed 40894483Ennes 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.
PubMed 21892588Ding 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.
PubMed 35187040Pettersson-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.
PubMed 30767573Jayasinghe 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.
PubMed 31323812Carter 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.
PubMed 37460680
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Dietary Patterns and Hair Zinc Levels With Body Composition, TNF-α, and Blood Pressure in Women of Reproductive Age (WRA) With Multi-Ethnicities in Jakarta: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07170904
- Acronym / sponsor ID
- DIVERSE / DIVERSE (Protocol # KET-1848)
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 12 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women of Reproductive Age (WRA) Participants | – | Other: Not applicable- observational studyA 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. |
Who may qualify
- Ages
- 19 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable- observational studyThis is an observational study; no interventions are administered to participants. | Other | Women of Reproductive Age (WRA) Participants |
Primary outcome
Dietary Zinc Intake
Time frame: At baseline (single assessment)
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.
Diet Quality Assessed by HEI-2020
Time frame: Baseline (cross-sectional assessment at enrollment)
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.
Planetary Health Diet Index (PHDI)
Time frame: Baseline (cross-sectional data collection)
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.
Ultra-Processed Food (UPF) intake
Time frame: Baseline (cross-sectional data collection)
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).
Body Composition (Fat Mass, Fat-Free Mass)
Time frame: At baseline (single assessment)
Measured using BOD POD to determine body fat percentage, fat mass, and fat-free mass
Hair Zinc Concentration
Time frame: At baseline (single assessment)
Zinc concentration measured from hair samples as an indicator of long-term zinc status
Blood Pressure
Time frame: At baseline (single assessment)
Systolic and diastolic blood pressure are measured to assess cardiovascular health status
1 secondary outcome
Inflammatory Biomarker Levels (TNF-α in Serum)
Time frame: At baseline (single assessment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Background: PubMed 40894483Lee 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.
- Background: PubMed 21892588Ennes 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.
- Background: PubMed 35187040Ding 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.
- Background: PubMed 30767573Pettersson-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.
- Background: PubMed 31323812Jayasinghe 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.
- Background: PubMed 37460680Carter 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.
- Individual participant dataSharing planned: No. No plan to share Individual Participant Data (IPD). Data transfer to any third party will adhere to the ethical principles of the Declaration of Helsinki and comply with university regulations and the laws of the Republic of Indonesia, thereby upholding the rights of patients/subjects.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rina Agustina, MD, PhD principal investigator
Dep of Nutrition, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Body Composition and Zinc Status, run by Universitas Indonesia at 1 site in Indonesia.
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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dhani Latifani, BSc, MSc (+6285868975494, dhanilatifani94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dietary Zinc Intake (time frame: At baseline (single assessment)). The study lists 7 primary outcomes in all. 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 NCT07170904, which also lists 6 linked publications.
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 4 Dec 2025.