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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
36
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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London、イギリス、W12 0NN
- Imperial College London
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
50年～65年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：ランダム化
- 介入モデル：階乗代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
他の名前：
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アクティブコンパレータ：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.
他の名前：
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他の：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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Insulin Sensitivity
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Body Composition
時間枠：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
時間枠：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)
時間枠：12 weeks
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12 weeks
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Body Weight
時間枠：Baseline, 12 weeks
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Baseline, 12 weeks
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2012年4月1日
一次修了 (実際)
2015年6月1日
研究の完了 (実際)
2016年1月1日
試験登録日
最初に提出
2012年9月11日
QC基準を満たした最初の提出物
2012年9月11日
最初の投稿 (見積もり)
2012年9月13日
学習記録の更新
投稿された最後の更新 (実際)
2020年1月27日
QC基準を満たした最後の更新が送信されました
2020年1月13日
最終確認日
2020年1月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。