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临床试验/NCT06032234
NCT06032234已完成不适用

Development and Evaluation of a Web-based Diet Quality Screener for Vegans (VEGANScreener)

Isabelle Herter-Aeberli1 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2023年9月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
89
试验地点
1
主要终点
Validity of the vegan screener

研究概览

简要总结

The primary objective of this study is to assess the construct validity and criterion validity for associations of the VEGANScreener with nutrient intakes from reference methods and associations with biomarkers of dietary intake. The investigators hypothesize that the screener is a valid tool to assess diet quality in the vegan population. The study will assess construct validity by testing whether the measure relates as it should to other measures (e.g., age, gender, education, SES differences).

The investigators will assess concurrent and predictive validity (types of criterion validity) by evaluating associations and agreement between 'gold standards', such as diet records, biomarkers, and multi-metabolite signatures of intake. The investigators will examine associations of vegan diet quality with biomarkers of nutritional status, biomarkers of disease, and anthropometric measures and hypothesize that a higher diet quality in vegans is associated with a more favourable profile among vegans, for example, a lower blood pressure. This study is part of the European VEGANScreener Consortium.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Self-reported vegans (≥2 years on a vegan diet; vegan diet defined as not consuming any dietary animal products more often than once/month, honey excluded)
  • Self-reported omnivores. Consuming on average daily (at least 5 times/week) meat/meat products.
  • Age 18 to 65 years (1:1 ratio 18-35,99 and 36-65)
  • Males and females (1:1 ratio)

排除标准

  • Self-identified pescatarians (excluding all meat, except for fish/seafood) and reductarians/flexitarians (intentionally reducing intake of animal-based products)
  • History of a disease known to affect intermediary metabolism (e.g., any diabetes on treatment, i.e. medication or lifestyle recommendations, thyreopathies, cancer etc.)
  • BMI>30 kg/m2
  • History of disease of intestinal integrity (i.e., inflammatory bowel disease, chronic pancreatitis, other malabsorption, etc.).
  • Pregnant or breastfeeding females.

结局指标

主要结局

Validity of the vegan screener

时间窗: Baseline

The validity will be assessed by calculating associations between the screener and reference method.

次要结局

  • Dietary intake(Baseline)
  • Vitamin D status(Baseline)
  • Potassium concentration(Baseline)
  • Eicosapentanoic acid(Baseline)
  • holo-transcobalamin(Baseline)
  • Vitamin B2 status(Baseline)
  • Vitamin C status(Baseline)
  • Calcium concentration(Baseline)
  • C-reactive protein concentration(Baseline)
  • Free fatty acid concentration(Baseline)
  • Height(Baseline)
  • Waist circumference(Baseline)
  • Hip circumference(Baseline)
  • Homocysteine status(Baseline)
  • Folic acid status(Baseline)
  • Ferritin concentration(Baseline)
  • Hemoglobin concentration(Baseline)
  • Uric acid concentration(Baseline)
  • LDL-cholesterol concentration(Baseline)
  • HDL-Cholesterol concentration(Baseline)
  • VEGANScreener(Baseline and day 2)
  • Food habits(Baseline)
  • Methoylmalonic acid(Baseline)
  • Zinc status(Baseline)
  • Selenoprotein-P status(Baseline)
  • Soluble transferrin receptor concentration(Baseline)
  • Triglyceride concentration(Baseline)
  • Cholesterol concentration(Baseline)
  • Magnesium status(Baseline)
  • Creatinine concentration(Baseline)
  • Urea concentration(Baseline)
  • Iodine concentration(Baseline)
  • Sodium concentration(Baseline)
  • Well being questionnaire(Baseline)
  • Docosahexanoic acid(Baseline)
  • Glucose concentration(Baseline)
  • Weight(Baseline)

研究者

发起方
Isabelle Herter-Aeberli
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Isabelle Herter-Aeberli

Principle Investigator

Swiss Federal Institute of Technology

研究点 (1)

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