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

23 marzo 2020 aggiornato da: 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

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

37

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Notts
      • Nottingham, Notts, Regno Unito, NG72UH
        • David Greenfield Human Physiology Unit

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 21 anni a 50 anni (Adulto)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: Control
Participants to continue on their habitual diet for 4 weeks
Sperimentale: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Fasting Serum total cholesterol concentration
Lasso di tempo: Week 0, 4,10 and 16
Fasting Serum total cholesterol concentration
Week 0, 4,10 and 16

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Fasting Serum LDL cholesterol concentration
Lasso di tempo: Week 0, 4,10 and 16
Fasting Serum LDL cholesterol concentration
Week 0, 4,10 and 16
Fasting Serum HDL cholesterol concentration
Lasso di tempo: Week 0, 4,10 and 16
Fasting Serum HDL cholesterol concentration
Week 0, 4,10 and 16
Fasting whole blood glucose concentration
Lasso di tempo: Week 0, 4,10 and 16
Fasting whole blood glucose concentration
Week 0, 4,10 and 16
Fasting Serum Insulin concentration
Lasso di tempo: Week 0, 4,10 and 16
Fasting Serum Insulin concentration
Week 0, 4,10 and 16
Resting, supine blood pressure
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: Week 0, 4,10 and 16
% body fat determined by Bio-electrical Impedance
Week 0, 4,10 and 16
Flow-mediated dilatation
Lasso di tempo: 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
Lasso di tempo: Week 0, 4,10 and 16
WHOQOL Questionnaire
Week 0, 4,10 and 16
Dietary macro-nutrient intake
Lasso di tempo: 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
Lasso di tempo: Week 0, 4,10 and 16
Energy intake of the diet determined from diet diaries
Week 0, 4,10 and 16
Meat intake
Lasso di tempo: 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
Lasso di tempo: Week 0,10 and 16
blood cell count, including haemoglobin
Week 0,10 and 16

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Andrew Salter, PhD, University of Nottingham

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 luglio 2015

Completamento primario (Effettivo)

1 settembre 2016

Completamento dello studio (Effettivo)

1 settembre 2016

Date di iscrizione allo studio

Primo inviato

15 settembre 2016

Primo inviato che soddisfa i criteri di controllo qualità

19 settembre 2016

Primo Inserito (Stima)

20 settembre 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

25 marzo 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

23 marzo 2020

Ultimo verificato

1 marzo 2020

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • TS/L005891/1

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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