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Impact of Reducing Dietary Intake of Red and Processed Meat Intake on Fasting Lipemia in Healthy Participants (ELM)

2020年3月23日 更新者:Elizabeth Simpson、University of Nottingham
Excessive meat consumption, particularly of red and processed meat, is associated with increased risk of developing a range of chronic diseases. Meat production also significantly contributes to the production of global greenhouse gasses (GHG). Given the predicted global increase in the human population, coupled with the rise in demand for meat within emerging economies, it has been suggested that strategies to alter dietary patterns and reduce meat intake should be devised. With the provision of appropriate non- or reduced-meat alternatives, this study aims to investigate whether free living subjects can significantly reduce their meat intake, and whether such dietary changes positively impact on a range of health measures

調査の概要

状態

完了

条件

詳細な説明

In UK adults, meat provides approximately 40% of the average daily protein intake and makes a significant contribution to intake of thiamin, niacin, vitamin B12, iron, zinc, potassium, and phosphorus. However, excessive consumption, particularly of red and processed meat, is associated with increased risk of developing a range of chronic diseases, including cardiovascular disease (CVD), obesity, type 2 diabetes and some cancers. Meat production significantly contributes to the production of greenhouse gasses (GHG) and hence global warming. Given the predicted global increase in the human population, coupled with the rise in demand for meat within emerging economies, it has been suggested that concerted efforts should be made to alter dietary patterns and reduce meat intake. Moreover, a number of reports have suggested that replacing meat with non-meat protein-rich products has health benefits. Such products tend to be inherently lower in total and saturated fat and, higher in fibre and as such, could also be cardioprotective.

The aim of this trial will be to investigate whether, with appropriate non/reduced-meat alternatives and motivational support, free living subjects can significantly reduce their meat intake and whether such dietary changes positively impact on a range of cardiovascular risk factors.

Trial design; A non-randomised, single group study design, with an initial control period will be used.

Participants; Forty healthy men and women will be recruited from the general population of Nottinghamshire, UK. All participants will attend the David Greenfield Human Physiology Unit (Queen's Medical Centre, Nottingham, UK) for an initial medical screening visit to confirm health status. In addition, blood pressure (BP) will be measured at the left upper arm (after lying semi-supine for 5min) using automated oscillometry, and body mass index (BMI) will be calculated from measured height and weight. If participants are suitable to take part with regards to their health questionnaire and BMI measures, a venous blood sample will then be taken to assess full blood count, urea, and electrolytes. Those taking lipid-lowering medication, or who report using nutritional strategies to lower their cholesterol, will be excluded. Participants will be accepted onto the trial if they report habitual consumption of 4-5 portions of red and/or processed meat per week (with 3-4 of these being consumed as main meals), they do not have food allergies related to soya or mycoprotein, and do not demonstrate any clinically significant abnormalities on screening.

Study Protocol; After recruitment, participants will be asked to record all food intake (including snacks and drinks) in a diet diary, for 4 days (3x week or work days, and 1x weekend or rest day) prior to assessment visit 1, for baseline assessment of macronutrient and energy intake. Individuals will be asked to complete further 4-day diet diaries in the week before assessment visits 2,3 and 4 (weeks 4, 10, and 16), to assess any changes in macronutrient or energy intake and meat consumption which may have occurred as a consequence of the intervention. Household measures will be used to estimate portion size, and diaries will be analysed using a food composition database. To calculate habitual diet composition, a mean daily intake will obtained from all 4 days of each recording period, and these data will be combined to produce group means.

Assessment visits will take place in the morning after the individual has fasted from midnight the night before. Initially, measurement of body mass will be made to the nearest 0.1kg using a Seca 882 Digital Scale, and waist and hip circumference will be assessed (with the participant standing) mid-way between the lowest rib and the iliac crest, and at the greater trochanters, respectively. Participants will then be asked to rest, semi-supine, on a couch for >5min before having their resting BP measured, and estimation of body composition made using bioelectrical impedance. A 5ml fasting blood sample will be taken for determination of serum insulin, total cholesterol, high density lipoprotein cholesterol (HDL), low density lipoprotein cholesterol (LDL), triacyl glycerides (TAG) and whole blood glucose. In a subset of the cohort (n=26, 13 Male:13 Female), flow mediated dilatation (FMD) will also be measured on the laboratory visits when fasted, after resting semi-supine for 1 and 2 hours.

Intervention; After visit 1 (week 0) assessment, participants will be asked not to make any changes to their lifestyle and to continue their habitual diet until visit 2 (week 4) when a second assessment will be made ('control' period). The 12 week 'intervention' period will begin on the day after the second study visit. Participants will be given information regarding how meat intake can safely be reduced in their diet, including a recipe book containing ideas for meals using meat analogues and other protein sources. A range of frozen meat-free (soya or mycoprotein 'mince', mycoprotein sausages, meatballs and 'steak strips') and reduced meat products (pork sausages, beef meatballs, beef mince and beef burgers made with 50% meat and 50% soya or mycoprotein) are available for the participants to use to aid this reduction in red meat intake. In addition, a range of dried beans (red kidney, haricot, black turtle), pulses (chick peas, green and red lentils) and grains (quinoa) will also be offered. Weekly telephone contact with the study participants will be maintained over the intervention period to improve compliance, to identify any problems and to arrange further food deliveries.

研究の種類

介入

入学 (実際)

37

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

    • Notts
      • Nottingham、Notts、イギリス、NG72UH
        • David Greenfield Human Physiology Unit

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

21年~50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:

BMI 18 - 28 kg/m2 Healthy Females should be premenopausal Good spoken and written English Consume 4-5 portions of red and/or processed meat per week consumption of greater than 70g per day

Exclusion Criteria:

Smoking Chronic diseases Hypertension Pregnancy / Breast feeding Chronic medication use (excluding oral contraceptives) Participation in any other research study three months prior to the screening or during study duration Clinically significant findings at screening

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:基礎科学
  • 割り当て:非ランダム化
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
介入なし:Control
Participants to continue on their habitual diet for 4 weeks
実験的:Meat Reduction
Participants asked to reduce their red and processed meat intake by 50% for 12 weeks
Advice, Motivational material and food products provided to participants

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
Fasting Serum total cholesterol concentration
時間枠:Week 0, 4,10 and 16
Fasting Serum total cholesterol concentration
Week 0, 4,10 and 16

二次結果の測定

結果測定
メジャーの説明
時間枠
Fasting Serum LDL cholesterol concentration
時間枠:Week 0, 4,10 and 16
Fasting Serum LDL cholesterol concentration
Week 0, 4,10 and 16
Fasting Serum HDL cholesterol concentration
時間枠:Week 0, 4,10 and 16
Fasting Serum HDL cholesterol concentration
Week 0, 4,10 and 16
Fasting whole blood glucose concentration
時間枠:Week 0, 4,10 and 16
Fasting whole blood glucose concentration
Week 0, 4,10 and 16
Fasting Serum Insulin concentration
時間枠:Week 0, 4,10 and 16
Fasting Serum Insulin concentration
Week 0, 4,10 and 16
Resting, supine blood pressure
時間枠:Week 0, 4,10 and 16
Resting, supine blood pressure (systolic and diastolic)
Week 0, 4,10 and 16
Body mass index calculated from measured height and weight (BMI)
時間枠:Week 0, 4,10 and 16
Body mass index calculated from measured height and weight (BMI)
Week 0, 4,10 and 16
% body fat determined by Bio-electrical Impedance
時間枠:Week 0, 4,10 and 16
% body fat determined by Bio-electrical Impedance
Week 0, 4,10 and 16
Flow-mediated dilatation
時間枠:Week 0, 4 and 16
Flow mediated dilatation at the brachial artery, measured using ultrasound (in a subset of participants)
Week 0, 4 and 16
Quality of Life Questionnaire
時間枠:Week 0, 4,10 and 16
WHOQOL Questionnaire
Week 0, 4,10 and 16
Dietary macro-nutrient intake
時間枠:Week 0, 4,10 and 16
Macro-nutrient intake of the diet determined from diet diaries
Week 0, 4,10 and 16
Dietary energy intake
時間枠:Week 0, 4,10 and 16
Energy intake of the diet determined from diet diaries
Week 0, 4,10 and 16
Meat intake
時間枠:Week 0, 4,10 and 16
daily red and processed meat intake determined from diet diaries
Week 0, 4,10 and 16
Full blood count
時間枠:Week 0,10 and 16
blood cell count, including haemoglobin
Week 0,10 and 16

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:Andrew Salter, PhD、University of Nottingham

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。

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 (実際)

2015年7月1日

一次修了 (実際)

2016年9月1日

研究の完了 (実際)

2016年9月1日

試験登録日

最初に提出

2016年9月15日

QC基準を満たした最初の提出物

2016年9月19日

最初の投稿 (見積もり)

2016年9月20日

学習記録の更新

投稿された最後の更新 (実際)

2020年3月25日

QC基準を満たした最後の更新が送信されました

2020年3月23日

最終確認日

2020年3月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • TS/L005891/1

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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