Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-01-02 @ 6:29 PM
Study NCT ID:
NCT07170904
Status:
RECRUITING
Last Update Posted:
2025-12-04
First Post:
2025-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dietary Patterns, Inflammation, Zinc Status, and Body Composition in Multi-Ethnic Women of Reproductive Age in Jakarta
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': '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.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 188}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2025-09-05', 'studyFirstSubmitQcDate': '2025-09-05', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dietary Zinc Intake', 'timeFrame': 'At baseline (single assessment)', 'description': '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.'}, {'measure': 'Diet Quality Assessed by HEI-2020', 'timeFrame': 'Baseline (cross-sectional assessment at enrollment)', 'description': '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.'}, {'measure': 'Planetary Health Diet Index (PHDI)', 'timeFrame': 'Baseline (cross-sectional data collection)', 'description': '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.'}, {'measure': 'Ultra-Processed Food (UPF) intake', 'timeFrame': 'Baseline (cross-sectional data collection)', 'description': '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).'}, {'measure': 'Body Composition (Fat Mass, Fat-Free Mass)', 'timeFrame': 'At baseline (single assessment)', 'description': 'Measured using BOD POD to determine body fat percentage, fat mass, and fat-free mass'}, {'measure': 'Hair Zinc Concentration', 'timeFrame': 'At baseline (single assessment)', 'description': 'Zinc concentration measured from hair samples as an indicator of long-term zinc status'}, {'measure': 'Blood Pressure', 'timeFrame': 'At baseline (single assessment)', 'description': 'Systolic and diastolic blood pressure are measured to assess cardiovascular health status'}], 'secondaryOutcomes': [{'measure': 'Inflammatory Biomarker Levels (TNF-α in Serum)', 'timeFrame': 'At baseline (single assessment)', 'description': 'Serum TNF-α measured as a marker of inflammation, assessed in approximately 30% of total participants (sub-sample)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['women of reproductive age', 'dietary assessment', 'hair zinc', 'TNF alpha', 'body composition', 'blood pressure', 'BOD POD'], 'conditions': ['Body Composition', 'Zinc Status', 'Dietary Analysis', 'TNF Alpha', 'Blood Pressure']}, 'referencesModule': {'references': [{'pmid': '40894483', 'type': 'BACKGROUND', 'citation': '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': '21892588', 'type': 'BACKGROUND', 'citation': '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': '35187040', 'type': 'BACKGROUND', 'citation': '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': '30767573', 'type': 'BACKGROUND', 'citation': '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': '31323812', 'type': 'BACKGROUND', 'citation': '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': '37460680', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 19-49 years\n* Residing in Jakarta for at least 6 months\n* Currently menstruating (not menopausal)\n* From Minangkabau, Sundanese, Javanese, Betawi, or Chinese ethnicity\n* Not pregnant or breastfeeding at the time of study\n\nExclusion Criteria:\n\n* History of chronic diseases (e.g., diabetes, cardiovascular disease, cancer)\n* Currently on a medically prescribed diet or taking medication affecting nutrient status\n* Any condition interfering with accurate body composition measurement'}, 'identificationModule': {'nctId': 'NCT07170904', 'acronym': 'DIVERSE', 'briefTitle': 'Dietary Patterns, Inflammation, Zinc Status, and Body Composition in Multi-Ethnic Women of Reproductive Age in Jakarta', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'DIVERSE (Protocol # KET-1848)'}, 'secondaryIdInfos': [{'id': 'NKB-298/UN2.RST/HKP.05.00/2024', 'type': 'OTHER_GRANT', 'domain': 'Universitas Indonesia'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women of Reproductive Age (WRA) Participants', 'description': '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.', 'interventionNames': ['Other: Not applicable- observational study']}], 'interventions': [{'name': 'Not applicable- observational study', 'type': 'OTHER', 'description': 'This is an observational study; no interventions are administered to participants.', 'armGroupLabels': ['Women of Reproductive Age (WRA) Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta Pusat', 'state': 'DKI Jakarta', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Dhani Latifani, B.Sc, M.Sc', 'role': 'CONTACT', 'email': 'dhanilatifani94@gmail.com', 'phone': '+6285868975494'}, {'name': 'Amalia Chairunnisa, B.App.Sc', 'role': 'CONTACT', 'email': 'achairunnisa@gmail.com', 'phone': '+6281317623966'}], 'facility': 'Human Nutrition Research Center (HNRC) Laboratory, IMERI, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia', 'geoPoint': {'lat': -6.1818, 'lon': 106.8223}}], 'centralContacts': [{'name': 'Dhani Latifani, BSc, MSc', 'role': 'CONTACT', 'email': 'dhanilatifani94@gmail.com', 'phone': '+6285868975494'}, {'name': 'Ana D Sakinah, BApp.Sc', 'role': 'CONTACT', 'email': 'anadinasakinah@gmail.com', 'phone': '+6282219194716'}], 'overallOfficials': [{'name': 'Rina Agustina, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dep of Nutrition, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Nutrition, Faculty of Medicine, Universitas Indonesia', 'investigatorFullName': 'Prof Rina Agustina, MD, PhD', 'investigatorAffiliation': 'Indonesia University'}}}}