AzTrials
AzTrials

LipidemiaELMNCT02907112

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

A study testing Meat reduction in people with Lipidemia, run by University of Nottingham at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 21 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Lipidemia
What is being tested?
Meat reduction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteUnited Kingdom
Study dates
Jul 2015to Sep 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • David Greenfield Human Physiology Unit

    Nottingham, Notts, NG72UH

Other trials in United Kingdom

About this study

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

Read the detailed description

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.

Conditions
Lipidemia
Being tested
Meat reduction
Keywords
meat intake, meat analogues, LDL Cholesterol, HDL Cholesterol
Medical subject headings
Hyperlipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Meat reductionBehavioural

    Advice, Motivational material and food products provided to participants

Study groups in NCT02907112
Study groupRoleWhat they receive
ControlNo interventionParticipants to continue on their habitual diet for 4 weeks
Meat ReductionExperimentalParticipants asked to reduce their red and processed meat intake by 50% for 12 weeks
Receives: Behavioral: Meat reduction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fasting Serum total cholesterol concentration

    Fasting Serum total cholesterol concentration

    Measured: Week 0, 4,10 and 16

Secondary outcomes (13)
  1. Fasting Serum LDL cholesterol concentration

    Fasting Serum LDL cholesterol concentration

    Measured: Week 0, 4,10 and 16

  2. Fasting Serum HDL cholesterol concentration

    Fasting Serum HDL cholesterol concentration

    Measured: Week 0, 4,10 and 16

  3. Fasting whole blood glucose concentration

    Fasting whole blood glucose concentration

    Measured: Week 0, 4,10 and 16

  4. Fasting Serum Insulin concentration

    Fasting Serum Insulin concentration

    Measured: Week 0, 4,10 and 16

  5. Resting, supine blood pressure

    Resting, supine blood pressure (systolic and diastolic)

    Measured: Week 0, 4,10 and 16

  6. Body mass index calculated from measured height and weight (BMI)

    Body mass index calculated from measured height and weight (BMI)

    Measured: Week 0, 4,10 and 16

  7. % body fat determined by Bio-electrical Impedance

    % body fat determined by Bio-electrical Impedance

    Measured: Week 0, 4,10 and 16

  8. Flow-mediated dilatation

    Flow mediated dilatation at the brachial artery, measured using ultrasound (in a subset of participants)

    Measured: Week 0, 4 and 16

  9. Quality of Life Questionnaire

    WHOQOL Questionnaire

    Measured: Week 0, 4,10 and 16

  10. Dietary macro-nutrient intake

    Macro-nutrient intake of the diet determined from diet diaries

    Measured: Week 0, 4,10 and 16

  11. Dietary energy intake

    Energy intake of the diet determined from diet diaries

    Measured: Week 0, 4,10 and 16

  12. Meat intake

    daily red and processed meat intake determined from diet diaries

    Measured: Week 0, 4,10 and 16

  13. Full blood count

    blood cell count, including haemoglobin

    Measured: Week 0,10 and 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2016 (estimated)
  2. Study startJul 2015
  3. Primary completionSep 2016
  4. Study completionSep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02907112
Sponsor's protocol ID
TS/L005891/1
Acronym
ELM
Status last verified
Mar 2020
First submitted
15 Sep 2016
Last updated
25 Mar 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Simpson EJ , Clark M , Razak AA , Salter A . The impact of reduced red and processed meat consumption on cardiovascular risk factors; an intervention trial in healthy volunteers. Food Funct. 2019 Oct 16;10(10):6690-6698. doi: 10.1039/c9fo00758j.

    PubMed 31559410

Questions about this trial

What is this clinical trial studying?

A study testing Meat reduction in people with Lipidemia, run by University of Nottingham at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fasting Serum total cholesterol concentration (time frame: Week 0, 4,10 and 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02907112, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.

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