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临床试验/NCT07170904
NCT07170904招募中不适用

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

Indonesia University1 个研究点 分布在 1 个国家目标入组 188 人开始时间: 2025年2月3日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
188
试验地点
1
主要终点
Dietary Zinc Intake

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
19 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Dietary Zinc Intake

时间窗: 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

时间窗: 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)

时间窗: 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

时间窗: 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)

时间窗: At baseline (single assessment)

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

Hair Zinc Concentration

时间窗: At baseline (single assessment)

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

Blood Pressure

时间窗: At baseline (single assessment)

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

次要结局

  • Inflammatory Biomarker Levels (TNF-α in Serum)(At baseline (single assessment))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof Rina Agustina, MD, PhD

Professor of Nutrition, Faculty of Medicine, Universitas Indonesia

Indonesia University

研究点 (1)

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