NCT Number: NCT07170904
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.
Interested in participating?
Request Info19 year–49 year
Female
Observational
Jakarta Pusat, DKI Jakarta, 10430, Indonesia
Location status: Recruiting
Amalia Chairunnisa, B.App.Sc
CONTACT
Dhani Latifani, B.Sc, M.Sc
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This is an observational study; no interventions are administered to participants.
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.
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.
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.
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).
Time frame: At baseline (single assessment)
Measured using BOD POD to determine body fat percentage, fat mass, and fat-free mass
Time frame: At baseline (single assessment)
Zinc concentration measured from hair samples as an indicator of long-term zinc status
Time frame: At baseline (single assessment)
Systolic and diastolic blood pressure are measured to assess cardiovascular health status
Time frame: At baseline (single assessment)
Serum TNF-α measured as a marker of inflammation, assessed in approximately 30% of total participants (sub-sample)
Contact information is provided by the study sponsor or research team.
Ana D Sakinah, BApp.Sc
CONTACT
Dhani Latifani, BSc, MSc
CONTACT
Indonesia University
Other
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
Acronym: DIVERSE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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