The Impact of Reformulated Foods on Cardiovascular Risk Factors (REFORM)
2014年12月3日 更新者：Julie Lovegrove、University of Reading
The Impact of Reformulated Product Consumption on Energy and Nutrient Intake, Body Composition, Vascular Function and Plasma Lipid and Glucose Concentrations
Specific policies on obesity reduction often include a recommendation to reduce sugar consumption as a means of lowering overall caloric intake.
Reformulating processed foods (e.g.
sugary products) is considered one of the key options for improving population diet.
The implications of regular consumption of reformulated products are not fully understood.
Previous studies have demonstrated that dietary compensation is common, although the extent is not fully elucidated.
In addition to the perceived impact of sugar consumption on weight control, high sugar intake, specifically sucrose and fructose, has been implicated in the increase of plasma lipids and markers of insulin resistance.
However to date no randomised controlled study has investigated whether the consumption of reformulated low sugar products as components of a habitual diet have a significant impact on plasma lipid, insulin or glucose concentrations within a free-living, non-diseased population.
It is hypothesised that exchange of reformulated, low sugar food products for habitually consumed foods will result in dietary compensation and minimal weight change compared with unmodified products and will have little impact on plasma glucose, insulin and lipid levels.
調査の概要
研究の種類
介入
入学 (実際)
50
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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Berks
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Reading、Berks、イギリス、RG6 6AP
- Department of Food and Nutritional Sciences, University of Reading
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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
20年～49年 (大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- Age: 20 - 49 years
- BMI 18.5 - 30 kg/m2
- Plasma glucose <7 mmol/l (Not diagnosed with diabetes)
- Plasma cholesterol <7 mmol/l
- Plasma TAG <2.3 mmol/l
- Normal liver and kidney function
- Haemoglobin (>110 g/l women; 140g/dl men)
Exclusion Criteria:
- Having suffered a myocardial infarction/stroke in the past 12 months
- diabetic (diagnosed or fasting glucose > 7 mmol/l)
- Smoking
- On drug treatment for hyperlipidaemia, hypertension, inflammation or hypercoagulation
- Suffering from renal or bowel disease or have a history of choleostatic liver or pancreatitis
- Excessive alcohol consumption
- History of alcohol abuse
- Following a reducing diet or vegan diet
- Taking any fish oil, fatty acid or vitamin and mineral supplements
- Participating in intensive aerobic activity for > 20 minutes 3 times per week
- Food allergies
- Anti-inflammatory usage
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：防止
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：トリプル
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：Reformulated products
Subjects were asked to supplement their habitual diet with reformulated sugar-reduced products for 8 weeks.
Subjects were provided with reformulated beverages, sauces, condiments and snacks.
They were asked to consume a minimum of 1 drink + 1 food portion intervention supplement daily, in exchange for habitually eaten equivalent foods.
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Subjects were asked to supplement their habitual diet with reformulated sugar-reduced products for 8 weeks.
Subjects were provided with reformulated beverages, sauces, condiments and snacks.
They were asked to consume a minimum of 1 drink + 1 food portion intervention supplement daily, in exchange for habitually eaten equivalent foods.
他の名前：
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実験的：Conventional products
Subjects were asked to supplement their habitual diet with conventional sugar products for 8 weeks.
Subjects were provided with conventional beverages, sauces, condiments and snacks.
They were asked to consume a minimum of 1 drink + 1 food portion intervention supplement daily, in exchange for habitually eaten equivalent foods.
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Subjects were asked to supplement their habitual diet with conventional sugar products for 8 weeks.
Subjects were provided with conventional beverages, sauces, condiments and snacks.
They were asked to consume a minimum of 1 drink + 1 food portion intervention supplement daily, in exchange for habitually eaten equivalent foods.
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 |
時間枠 |
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Changes in body weight and body composition
時間枠：20 weeks. Baseline and week 8 assessments for two dietary intervention arms
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20 weeks. Baseline and week 8 assessments for two dietary intervention arms
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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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Changes in energy and nutrient intake
時間枠：20 weeks. Run-in period and week 7 assessments for two dietary intervention arms
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20 weeks. Run-in period and week 7 assessments for two dietary intervention arms
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Changes in appetite and mood ratings
時間枠：20 weeks. Run-in period and week 7 assessments for two dietary intervention arms
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Subjective sensations of appetite and mood by visual analogue scale
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20 weeks. Run-in period and week 7 assessments for two dietary intervention arms
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Changes in physical activity levels
時間枠：20 weeks. Run-in period and week 7 assessments for two dietary intervention arms
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Measured by accelerometry
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20 weeks. Run-in period and week 7 assessments for two dietary intervention arms
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Changes in fasting plasma lipid, insulin and glucose concentrations
時間枠：20 weeks. Baseline and week 8 assessments for two dietary intervention arms
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20 weeks. Baseline and week 8 assessments for two dietary intervention arms
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Changes in vascular stiffness by pulse wave analysis (PWA) and digital volume pulse (DVP)
時間枠：20 weeks. Baseline and week 8 assessments for two dietary intervention arms
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20 weeks. Baseline and week 8 assessments for two dietary intervention arms
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Changes in cardiovascular risk factors (blood pressure, inflammatory markers)
時間枠：20 weeks. Baseline and week 8 assessments for two dietary intervention arms
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20 weeks. Baseline and week 8 assessments for two dietary intervention arms
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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
捜査官
- 主任研究者：Prof Julie A Lovegrove, BSc, PhD, RNutr、University of Reading
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
- Reid M, Hammersley R, Duffy M. Effects of sucrose drinks on macronutrient intake, body weight, and mood state in overweight women over 4 weeks. Appetite. 2010 Aug;55(1):130-6. doi: 10.1016/j.appet.2010.05.001. Epub 2010 May 12.
- Reid M, Hammersley R, Hill AJ, Skidmore P. Long-term dietary compensation for added sugar: effects of supplementary sucrose drinks over a 4-week period. Br J Nutr. 2007 Jan;97(1):193-203. doi: 10.1017/S0007114507252705.
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3月1日
一次修了 (実際)
2013年3月1日
研究の完了 (実際)
2013年3月1日
試験登録日
最初に提出
2012年7月18日
QC基準を満たした最初の提出物
2012年7月18日
最初の投稿 (見積もり)
2012年7月20日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年12月4日
QC基準を満たした最後の更新が送信されました
2014年12月3日
最終確認日
2014年12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。
Reformulated productsの臨床試験
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Duke UniversityDoris Duke Charitable Foundation完了