Application of New Technologies and Tools to Nutrition Research (NutriTech)
2020年1月13日 更新者：Imperial College London
The overall objective of the research is to develop new methods for studying the link between diet, health and disease.
研究概览
详细说明
The enquiry consists of two part. A metabolomic biomarker discovery study followed by a randomised controlled trial of moderate dietary induced weight loss.
A cohort of moderately overweight men and women will undergo a metabolomic study follow by randomised controlled trial of a healthy diet with a 20% energy restriction for a 12 week period. This intervention will improve the volunteer's body composition and reduce their risk of developing diabetes.
Extensive tests will be conducted before and after the dietary intervention using emerging technologies with current state-of-the-art methods. These tests will monitor the numerous physiological adaptations that have occurred on a gene, cell, organ and organismic level.
The study will, therefore, aim for a scientific breakthrough by developing a series of novel biological "markers" that can accurately determine an individual's health status.
研究类型
介入性
注册 (实际的)
36
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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London、英国、W12 0NN
- Imperial College London
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
50年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Healthy overweight volunteers (body mass index (BMI) of 25-30 kg/m2)
- Age between 50-65 years
Exclusion Criteria:
- Weight change of ≥ 3kg in the preceding 3 months
- Current smokers
- Substance abuse
- Excess alcohol intake
- Pregnancy
- Diabetes
- Cardiovascular disease
- Cancer
- Gastrointestinal disease e.g. inflammatory bowel disease or irritable bowel syndrome
- Kidney disease
- Liver disease
- Pancreatitis
- Have any metallic or magnetic implants such as pacemakers
- Use of medications likely to interfere with energy metabolism, appetite regulation and hormonal balance, including: anti inflammatory drugs or steroids, antibiotics, androgens, phenytoin, erythromycin or thyroid hormones.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：随机化
- 介入模型：阶乘赋值
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Life style advice
reduce energy intake by 20% less than estimated energy expenditure.
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Metabolomic inquiry followed by a 12 week energy intake restriction.
This study is part of a very large European study called EPIC.
Only the results by Lee et al. 2016 have been presented here.
The results of the study published by Cheung 2017 are from a different study.
therefore the entries for the results are correct.
For this particular study, participants were not randomly assigned to one of five different diets; red meat, fish, poultry, processed meat or a supplement and vegetarian option.
In summary, both studies (lee and cheung) are considered as separate trials and results of the first phase where participants were assigned to one of five different diets, are reported separately.
Unfortunately no different NCT number is available.
其他名称：
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有源比较器：UK background diet
Diet where energy intake will be matched with estimated energy expenditure.
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Metabolomic inquiry followed by a 12 week energy intake restriction.
This study is part of a very large European study called EPIC.
Only the results by Lee et al. 2016 have been presented here.
The results of the study published by Cheung 2017 are from a different study.
therefore the entries for the results are correct.
For this particular study, participants were not randomly assigned to one of five different diets; red meat, fish, poultry, processed meat or a supplement and vegetarian option.
In summary, both studies (lee and cheung) are considered as separate trials and results of the first phase where participants were assigned to one of five different diets, are reported separately.
Unfortunately no different NCT number is available.
其他名称：
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其他：Metabolomic inquiry
This inquiry took place prior to the randomized controlled trial and include 50 volunteers who will then be asked to volunteers of the weight loss study.
Were randomly assigned to one of five different diets; red meat, fish, poultry, processed meat or a supplement and vegetarian option.
|
Metabolomic inquiry followed by a 12 week energy intake restriction.
This study is part of a very large European study called EPIC.
Only the results by Lee et al. 2016 have been presented here.
The results of the study published by Cheung 2017 are from a different study.
therefore the entries for the results are correct.
For this particular study, participants were not randomly assigned to one of five different diets; red meat, fish, poultry, processed meat or a supplement and vegetarian option.
In summary, both studies (lee and cheung) are considered as separate trials and results of the first phase where participants were assigned to one of five different diets, are reported separately.
Unfortunately no different NCT number is available.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Insulin Sensitivity
大体时间：Baseline, 12 weeks
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Glucose Infusion rate assessed by the euglycemic hyperinsulinemic clamp.
Insulin Sensitivity assessment was only performed in the "Exercise" and "Exercise, Control" groups.
No data were collected for this Outcome from the remaining groups.
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Baseline, 12 weeks
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Metabolomic Biomarker Discovery - Changes in Blood Plasma Cholesterol
大体时间：Baseline, 12 weeks
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Changes in blood plasma cholesterol in mg/dL- baseline to 12 weeks, after treatment.
Statistical Analysis was performed only for the "Diet" Arm/Group.
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Baseline, 12 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Body Composition
大体时间：Baseline, 12 weeks
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Body Composition assessed by BMI
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Baseline, 12 weeks
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Changes in Adipocyte Morphology
大体时间：12 weeks
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Percentage Change in total adipose tissue assessed by MRI
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12 weeks
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Genome Integrity (DNA Methylation and Telomere Length)
大体时间：12 weeks
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12 weeks
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Body Weight
大体时间：Baseline, 12 weeks
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Baseline, 12 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Lee S, Norheim F, Langleite TM, Noreng HJ, Storas TH, Afman LA, Frost G, Bell JD, Thomas EL, Kolnes KJ, Tangen DS, Stadheim HK, Gilfillan GD, Gulseth HL, Birkeland KI, Jensen J, Drevon CA, Holen T; NutriTech Consortium. Effect of energy restriction and physical exercise intervention on phenotypic flexibility as examined by transcriptomics analyses of mRNA from adipose tissue and whole body magnetic resonance imaging. Physiol Rep. 2016 Nov;4(21):e13019. doi: 10.14814/phy2.13019.
- Cheung W, Keski-Rahkonen P, Assi N, Ferrari P, Freisling H, Rinaldi S, Slimani N, Zamora-Ros R, Rundle M, Frost G, Gibbons H, Carr E, Brennan L, Cross AJ, Pala V, Panico S, Sacerdote C, Palli D, Tumino R, Kuhn T, Kaaks R, Boeing H, Floegel A, Mancini F, Boutron-Ruault MC, Baglietto L, Trichopoulou A, Naska A, Orfanos P, Scalbert A. A metabolomic study of biomarkers of meat and fish intake. Am J Clin Nutr. 2017 Mar;105(3):600-608. doi: 10.3945/ajcn.116.146639. Epub 2017 Jan 25.
- Yin X, Gibbons H, Rundle M, Frost G, McNulty BA, Nugent AP, Walton J, Flynn A, Gibney MJ, Brennan L. Estimation of Chicken Intake by Adults Using Metabolomics-Derived Markers. J Nutr. 2017 Oct 1;147(10):1850-1857. doi: 10.3945/jn.117.252197.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年4月1日
初级完成 (实际的)
2015年6月1日
研究完成 (实际的)
2016年1月1日
研究注册日期
首次提交
2012年9月11日
首先提交符合 QC 标准的
2012年9月11日
首次发布 (估计)
2012年9月13日
研究记录更新
最后更新发布 (实际的)
2020年1月27日
上次提交的符合 QC 标准的更新
2020年1月13日
最后验证
2020年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.