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Набор по приглашению NCT06745817

Challenges in Achieving Adequate Dietary Status of Women

Наблюдательное Nutritional Status Nutrient Deficiency Micronutrient Deficiency Vitamin D Deficiency

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Assessement of nutritional status, Dermis density and thickness, Skin elasticity, Body composition measurement.
Кому может быть актуально
Состояния в реестре: Nutritional Status, Nutrient Deficiency, Micronutrient Deficiency, Vitamin D Deficiency. Базовые параметры: 20 лет — 49 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Словения
Следующий шаг
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Официальное название

Challenges in Achieving Adequate Dietary Status of Women of Reproductive Age (NutriFem)

Обзор

The aim of the study is to investigate the dietary habits of women of reproductive age (20-49 years). We aim to obtain epidemiological data on the intake and adequacy of key macronutrients and micronutrients, as well as to explore associations with various health indicators. Additionally, we will focus on the nutritional status of subgroups with specific dietary practices, such as vegetarians and vegans.

Подробное описание

Key scientific challenges addressed in this study are to investigate the dietary habits and nutritional status of women of reproductive age, to provide epidemiological data on the nutrient intakes in this group (including intakes of key micronutrients) and investigate their relationship with various markers of health. We will evaluate dietary behaviours and special dietary practices among women of reproductive age in Slovenia, through age-representative sampling approach. We will also detailly assess dietary supplementation practices in this population group. Dietary intakes of macro and key micronutrients and nutritional/health status will be evaluated using a cross-sectional epidemiological study.

Further we will investigate links between dietary behaviours with nutritional and health status in order to identify increased nutritional and health risk, as well as potential benefits of different dietary practices. We will particularly focus into following sub-groups of women: omnivorous women, that do not follow any special diet, women that follow vegetarian diet, and women that follow vegan diet. In order to investigate the status of the key micronutrients, standard blood biomarkers will be used. This will allow us to determine nutritional status for iron, folate, vitamin B12 and vitamin D. Body composition will be estimated using bioelectrical impedance spectroscopy (BIS). Other measurements of health-related parameters will include tissue protein density using ultrasonography.

Study results will give insights into the nutritional status in general group of women of reproductive age and enable us to identify links between dietary behaviours with nutritional as well as health status. Through that approach we will be able to identify potential risk for deficiencies of nutrients in studied population group.

Applying a highly multidisciplinary approach and building on previous research we will address the following:

* evaluate dietary behaviours of women of reproductive age (20-49 years) through representative sampling approach. This will enable identification of diet related risks in this group. * determine dietary supplementation practices of women of reproductive age (20-49 years). This will allow us to better estimate intakes of specific nutrients, as supplements can be important dietary source of nutrients. * investigate nutritional status of women of reproductive age (20-49 years) in Slovenia with a combination of validated standard dietary assessment methods and blood biomarkers. This will enable also insights in nutritional status for key micronutrients, including iron, folate, vitamin B12 and vitamin D. * investigate links between dietary behaviours with nutritional/health status, providing information about sub-populations with higher health risks. To enable this, population of omnivorous subjects will be compared with those on vegetarian and vegan diet.

Вмешательства

  • Диагностический тест Assessement of nutritional status
    Assessment of socio-demographic parameters, anthropometric and body composition parameters, food intake (dietary recalls, food propensity questionnaire) and nutritional status (blood biomarkers)
  • Диагностический тест Dermis density and thickness
    Dermis density and thickness will be measured using ultrasonography with Cortex DermaLab 20 MHz US probe.
  • Диагностический тест Skin elasticity
    Skin elasticity will be measured using Cortex DermaLab elasticity probe.
  • Диагностический тест Body composition measurement
    Body composition will be measured using Biostat Multiscan 5000.
  • Диагностический тест Screening questionnaire
    Screening questionnaire: assessment of socio-demographic parameters, use of food supplements, health status, dietary habits

Первичные конечные точки

  • Assessment of nutrient intake [Срок оценки: 1 year]
  • Assessment of nutritional deficiencies [Срок оценки: 1 year]
Вторичные конечные точки (8)
  • Assessment of inadequate vitamin D status [Срок оценки: 1 year]
  • Assessment of inadequate vitamin B12 status [Срок оценки: 1 year]
  • Assessment of inadequate folate status [Срок оценки: 1 year]
  • Assessment of inadequate iron status [Срок оценки: 1 year]
  • Assessment of body composition [Срок оценки: 1 year]
  • Assessment of dermal thickness [Срок оценки: 1 year]
  • Assessment of dermal density [Срок оценки: 1 year]
  • Assessment of skin elasticity [Срок оценки: 1 year]

Критерии участия

Критерии включения

  • Age: 20 to 49 years
  • Gender: female
  • Agrees to participate in the study (has signed a consent form)

Критерии исключения

  • Menopause (absence of menstruation for at least 12 months, unless the absence is due to hormonal contraception) or post-menopause
  • Pregnancy

Reasons for excluding a participant during the study:

  • Inability to participate in the study
  • Wishes to discontinue participation
  • Incomplete data provided

Additional inclusion criteria for including subpopulations in the second part of the study:

Vegetarians:

  • Have followed a vegetarian diet for at least 2 years and do not consume meat or fish more than once a month
  • Consume eggs and dairy products more than once a month

Vegans:

\- Have followed a vegan diet for at least 2 years and do not consume any animal products more than once a month

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Экологическое

Центры проведения

Словения · 3 центра
  • National Institute of Public Health, Slovenia — Ljubljana
  • Nutrition Institute, Ljubljana — Ljubljana
  • VIST Fakulteta za aplikativne vede Zmitek — Ljubljana

Идентификаторы

NCT: NCT06745817 · KEP-4-14/2024 · L3-50125 · L3-50125

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗