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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants to continue on their habitual diet for 4 weeks |
| Meat Reduction | Experimental | Participants 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.
Fasting Serum total cholesterol concentration
Fasting Serum total cholesterol concentration
Measured: Week 0, 4,10 and 16
Secondary outcomes (13)
Fasting Serum LDL cholesterol concentration
Fasting Serum LDL cholesterol concentration
Measured: Week 0, 4,10 and 16
Fasting Serum HDL cholesterol concentration
Fasting Serum HDL cholesterol concentration
Measured: Week 0, 4,10 and 16
Fasting whole blood glucose concentration
Fasting whole blood glucose concentration
Measured: Week 0, 4,10 and 16
Fasting Serum Insulin concentration
Fasting Serum Insulin concentration
Measured: Week 0, 4,10 and 16
Resting, supine blood pressure
Resting, supine blood pressure (systolic and diastolic)
Measured: Week 0, 4,10 and 16
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
% body fat determined by Bio-electrical Impedance
% body fat determined by Bio-electrical Impedance
Measured: Week 0, 4,10 and 16
Flow-mediated dilatation
Flow mediated dilatation at the brachial artery, measured using ultrasound (in a subset of participants)
Measured: Week 0, 4 and 16
Quality of Life Questionnaire
WHOQOL Questionnaire
Measured: Week 0, 4,10 and 16
Dietary macro-nutrient intake
Macro-nutrient intake of the diet determined from diet diaries
Measured: Week 0, 4,10 and 16
Dietary energy intake
Energy intake of the diet determined from diet diaries
Measured: Week 0, 4,10 and 16
Meat intake
daily red and processed meat intake determined from diet diaries
Measured: Week 0, 4,10 and 16
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.
- First posted20 Sep 2016 (estimated)
- Study startJul 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LipidemiaStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Biotechnology and Biological Sciences Research Council
- Responsible party
- Principal investigator, Elizabeth Simpson, University of Nottingham
- Investigators
- Andrew Salter, PhD, Principal investigator, University of Nottingham
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Reducing Dietary Intake of Red and Processed Meat Intake on Fasting Lipemia in Healthy Participants
- ClinicalTrials.gov ID
- NCT02907112
- Acronym / sponsor ID
- ELM / TS/L005891/1
- Conditions
- Lipidemia
- Keywords
- meat intake, meat analogues, LDL Cholesterol, HDL Cholesterol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Biotechnology and Biological Sciences Research Council
- Study start
- Jul 2015 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 20 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants to continue on their habitual diet for 4 weeks |
| Meat Reduction | Experimental | Behavioral: Meat reductionParticipants asked to reduce their red and processed meat intake by 50% for 12 weeks |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meat reductionAdvice, Motivational material and food products provided to participants | Behavioural | Meat Reduction |
Primary outcome
Fasting Serum total cholesterol concentration
Time frame: Week 0, 4,10 and 16
Fasting Serum total cholesterol concentration
13 secondary outcomes
Fasting Serum LDL cholesterol concentration
Time frame: Week 0, 4,10 and 16
Fasting Serum HDL cholesterol concentration
Time frame: Week 0, 4,10 and 16
Fasting whole blood glucose concentration
Time frame: Week 0, 4,10 and 16
Fasting Serum Insulin concentration
Time frame: Week 0, 4,10 and 16
Resting, supine blood pressure
Time frame: Week 0, 4,10 and 16
Body mass index calculated from measured height and weight (BMI)
Time frame: Week 0, 4,10 and 16
% body fat determined by Bio-electrical Impedance
Time frame: Week 0, 4,10 and 16
Flow-mediated dilatation
Time frame: Week 0, 4 and 16
Quality of Life Questionnaire
Time frame: Week 0, 4,10 and 16
Dietary macro-nutrient intake
Time frame: Week 0, 4,10 and 16
Dietary energy intake
Time frame: Week 0, 4,10 and 16
Meat intake
Time frame: Week 0, 4,10 and 16
Full blood count
Time frame: Week 0,10 and 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Results publication: PubMed 31559410Simpson 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.
- Individual participant dataSharing planned: No
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Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Salter, PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
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.