跳至主要内容
临床试验/NCT07128940
NCT07128940已完成不适用

Biomarker pAtterns Reflecting habITual fOod iNtakE: the BARITONE Project

Göteborg University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年9月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
Patterns of metabolites in plasma/serum

研究概览

简要总结

The BARITONE study's overall aim is to understand how our eating habits affect our long-term health. By identifying biological traces in blood, urine and other samples - so-called biomarkers - the investigators want to be able to see what people actually eat, such as protein from different food sources as well as fruit, berries and vegetables. These biomarkers could in the future improve the possibilities to find out how dietary habits affect the risk of disease.

The investigators are targeting healthy people who are interested in participating in research on biomarkers of dietary intake. The research is divided into a cross-sectional study, where the investigators collect data on the participant's usual dietary intake, health and biological samples at the screening visit, and an cross over intervention study that involves eating three different diets (meat, fish, vegetarian) for a total of 3 weeks with one week wash-out in between.

详细描述

PURPOSE AND AIMS

The aims of the present project are to:

  1. Identify and validate biomarker patterns of intake of the different food sources for protein, i.e., meat, fish and plant-based sources
  2. Identify and validate biomarker patterns of high and low intake of the food group vegetables, fruit and berries.

Validation here includes evaluation of plausibility, robustness, and dose-response.

PROJECT DESCRIPTION Validated biomarkers are still lacking for food groups that are crucial when evaluating dietary intake, such as meat, fish and plant-based sources of protein (i.e., legumes such as lentils, peas and beans and cereal proteins such as oat- and wheat-protein); and for berries, fruits, and vegetables. For sources of protein, a well-controlled cross-over trial is needed where biomarkers of any intake of these different sources are evaluated in different biofluids. For berries, fruit and vegetables, a challenge is that no obvious control food group exists. Individuals with low consumption from this food group may instead consume any type of food. Hence, the investigators aim to evaluate biomarkers that separate consumers of low vs high intake. The investigators will follow the criteria for discovering and validating biomarkers suggested by Dragstedt et al (2018), here applied to patterns of biomarkers. The investigators will identify patterns of putative biomarkers of recent intake in biofluids in a well-controlled feeding trial (BARITONE-intervention) and develop prediction models of being a consumer/non-consumer or high/low consumer using machine learning. The robustness and dose-response of the models will be tested in data on habitual intake (BARITONE sample). Data for protein sources and berries, fruits and vegetables will be generated in the planned BARITONE-intervention trial.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Outcomes Assessor)

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

  • Healthy adult
  • 18-65 years
  • BMI 18.5-30 kg/m²
  • Willing to consume the three diets i.e. meat, fish, and vegetarian
  • Understands Swedish
  • Low intake of vegetables, fruit and berries (lowest tertile of screened participants, estimated <100g day) or high intake of vegetables, fruit and berries (highest tertile of screened participants, estimated >400g day)

排除标准

  • Pregnancy and lactation
  • Diagnosis of cancer or other life threatening diseases
  • Diagnosis of metabolic or food related diseases inluding diabetes, inflammatory bowel disease, hypothyroidism or celiak disease.
  • Medication that influences the metabolism such as blood lipid lowering medication, insulin, etc.
  • Use of drugs other than medication and alcohol
  • Nicotine use (snuff, vaping and smoking)

研究组 & 干预措施

Meat

Experimental

All food provided for a week, including a variety of meat

干预措施: Meat vs Vegetarian (Other)

Fish

Experimental

All food provided for a week, including a variety of fish and shellfish

干预措施: Meat vs fish (Other)

Fish

Experimental

All food provided for a week, including a variety of fish and shellfish

干预措施: Fish vs Vegetarian (Other)

Vegetarian

Experimental

All food provided for a week, diet (no fish or meat)

干预措施: Meat vs Vegetarian (Other)

Vegetarian

Experimental

All food provided for a week, diet (no fish or meat)

干预措施: Fish vs Vegetarian (Other)

Meat

Experimental

All food provided for a week, including a variety of meat

干预措施: Meat vs fish (Other)

结局指标

主要结局

Patterns of metabolites in plasma/serum

时间窗: 1 week

Metabolites analysed by LC-MS/GC-MS or NMR for metabolomics studies (changes in patterns of metabolites). Metabolite patterns will be compared by multivariate methods such as HDA-OPLS between the three diets. Metabolite patterns will be compared by multivariate methods such as OPLS-DA comparing high and low intake of vegetables, fruit and berries.

次要结局

  • Patterns of lipids(1 week)
  • Patterns of metabolites in urine(1 week)
  • Class disciminating metabolites in plasma/serum(1 week)

研究者

发起方
Göteborg University
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验