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临床试验/NCT04486105
NCT04486105Unknown不适用

Investigation of Sucrose-induced Metabolic Adaptation and Biomarkers of Chronic Sucrose Intake in Humans Using a Multi-omic Approach

Northumbria University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Metabolome

研究概览

简要总结

With free sugar intake proving to be of a concern within the general public, discovery and validation of a new biomarker will allow for more consistent measurement of sucrose intake. Furthermore, using a multi-omic approach the investigators will identify metabolic perturbations to the metabolome and proteome.

详细描述

Excessive free sugar intake is of concern within the general public, as intakes have been associated with weight gain and cardiovascular disease. Average intakes are over double that of the 5% of total energy intake that is recommended by the Science Advisory Committee on Nutrition, but intakes are calculated from observational measures that lack sensitivity and discovery and validation of a new biomarker from biological fluids may allow for more specific measurement and a better understanding of intake:disease relationships. Furthermore, understanding the biochemistry of sucrose intake will allow the identification of damage occurrence and alternative metabolic pathways, as well as novel protein damage that occur with chronic sucrose exposure.

This study aims to identify a biomarker of chronic sucrose consumption using metabolite profiling technology. The study will be composed of a randomised controlled intervention trial, in which participants will be required to consume an amount of sucrose (0-120g/d) every day for 7 days and provide biofluid samples (urine and blood) before the initiation, during and following the intervention; that will undergo metabolic analysis. Furthermore, participants will have their anthropometrics and dietary intake monitored throughout the study. The biomarker will also be validated against the dietary information and correlated with indices of health and sucrose-induced damage. The investigators will also monitor the feasibility and acceptability of chronic sucrose intake during the intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
19 Years 至 64 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age 19-64, healthy diagnosis

排除标准

  • •gastrointestinal issues, doesn't consume sugar

研究组 & 干预措施

120g sucrose ingestion

Experimental

120g sucrose treatment on top of habitual diet for one week

干预措施: sucrose (Dietary Supplement)

80g sucrose ingestion

Experimental

80g sucrose treatment on top of habitual diet for one week

干预措施: sucrose (Dietary Supplement)

40g sucrose ingestion

Experimental

40g sucrose treatment on top of habitual diet for one week

干预措施: sucrose (Dietary Supplement)

control

Placebo Comparator

vehicle only for one week

干预措施: sucrose (Dietary Supplement)

结局指标

主要结局

Metabolome

时间窗: change in the urinary metabolome following one week intervention

Metabolite profiling of urine samples, obtaining a profile of approximately 5000 metabolite intensities in urine

Blood pressure

时间窗: change in blood pressure following one week intervention

Measurement of systolic and diastolic blood pressure

Body composition

时间窗: change in percentage body fat following one week intervention

measurement of percentage body fat

Body composition

时间窗: change in body mass index following one week intervention

measurement of body mass index

次要结局

  • food diary analysis(change in dietary intake following the week intervention)

研究者

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

John Lodge

Associate Professor

Northumbria University

研究点 (1)

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