Cardiometabolic SyndromeNCT05198024
Nutrition Education in Cardiac Rehabilitation
A study testing Nutrition knowledge in people with Cardiometabolic Syndrome, run by Jonathan Sinclair at 1 site in United Kingdom.
Trial summary
Coronary heart disease is one of the United Kingdom's biggest killers. In the UK alone 175,000 myocardial infarctions are recorded annually. To lower the financial burden on the National Health Service, cardiac rehabilitation facilitates a systematic and multidisciplinary approach to secondary prevention aimed to… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cardiometabolic Syndrome
- What is being tested?
- Nutrition knowledge
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2018to 1 Jan 2020
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to give informed consent
- Engaged in phase IV cardiac rehabilitation program
- Patient has read and understood the Patient Information Sheet
- Clinically stable (symptoms and medication)
Who cannot join
- Clinically Unstable (symptoms and medication)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Central Lancashire
Preston, Lancashire, PR4 0PE
About this study
Official title: Effects of Nutrition Education in Cardiac Rehabilitation Patients; a 3-arm Randomized Controlled Trial
Coronary heart disease is one of the United Kingdom's biggest killers. In the UK alone 175,000 myocardial infarctions are recorded annually. To lower the financial burden on the National Health Service, cardiac rehabilitation facilitates a systematic and multidisciplinary approach to secondary prevention aimed to improve functional capacity and health-related quality of life, lower rehospitalisation rates and reduce all-cause and cardiovascular mortality with exercise training being the cornerstones. The effectiveness of
Cardiac rehabilitation programmes in delivering effective secondary prevention has long been established. Improvements are recorded in cardiovascular endurance, muscular strength and endurance, balance, co-ordination, and quality of life. However, many patients see little or no change in body mass and body mass index, an independent risk factor for coronary heart disease. Interestingly, the inclusion of nutrition education is rarely reported within specific Cardiac rehabilitation settings, therefore evidence of best practice remains elusive and warrants further investigation.
Read more
The aim of this trial is to compare:
- Usual care - Where patients access to two exercise classes per week and all facilities normally available as part of their cardiac rehabilitation programme. Patients in this group will undergo this approach for 12-weeks.
- Usual care + Biggest loser - In addition to Usual care, patients in this group took part in the 'Biggest loser' program in which the patients attended weekly sessions outside of their usual exercise class times. Each session follows a specific theme based on British Heart Foundation healthy eating guidelines. Participants will undergo this approach for 6-weeks and then switch to usual care for 6-weeks.
- Usual care + New Education programme. In addition to Usual care, the same weekly topics as the biggest loser are covered yet with bespoke information regarding portion sizes and recipes provided each week and patients given a challenge each week in relation to the topic being covered e.g. include more vegetables. Participants will undergo this approach for 6-weeks and then switch to usual care for 6-weeks.
Patients will be tested at baseline, 6-weeks and 12-weeks.
- Conditions
- Cardiometabolic Syndrome
- Being tested
- Nutrition knowledge
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition knowledgeBehavioural
Nutrition knowledge either 'Usual care plus new education programme' or 'Usual care plus biggest loser'
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Placebo comparator | Where patients access to two exercise classes per week and all facilities as part of their cardiac rehabilitation. In addition to this, patients in this group took part in the 'Biggest loser' program in which the patients attended weekly sessions outside of their usual exercise class times. Each session follows a specific theme based on British Heart Foundation healthy eating guidelines.
Participants will undergo this approach for 6-weeks and then switch to usual care for 6-weeks. Receives: Behavioral: Nutrition knowledge |
| Usual care plus biggest loser | Experimental | Where patients access to two exercise classes per week and all facilities as part of their cardiac rehabilitation. In addition to this, patients in this group took part in the 'Biggest loser' program in which the patients attended weekly sessions outside of their usual exercise class times. Each session follows a specific theme based on British Heart Foundation healthy eating guidelines.
Participants will undergo this approach for 6-weeks and then switch to usual care for 6-weeks. Receives: Behavioral: Nutrition knowledge |
| Usual care plus new education programme | Experimental | Where patients access to two exercise classes per week and all facilities as part of their cardiac rehabilitation. In addition to this, patients in this group too part in a new education programme (anecdotally referred to as "Healthy Heart Happy You") in which the same weekly topics as the biggest loser are covered yet with bespoke information regarding portion sizes and recipes provided each week and patients given a challenge each week in relation to the topic being covered e.g. include more vegetables.
Participants will undergo this approach for 6-weeks and then switch to usual care for 6-weeks. Receives: Behavioral: Nutrition knowledge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Systolic and diastolic blood pressure - measured using a digital blood pressure monitor
Measured: Baseline
Blood pressure
Systolic and diastolic blood pressure - measured using a digital blood pressure monitor
Measured: 6-weeks
Blood pressure
Systolic and diastolic blood pressure - measured using a digital blood pressure monitor
Measured: 12-weeks
Waist to hip ratio
Ratio of waist to hip circumference - measured using anthropocentric tape
Measured: Baseline
Waist to hip ratio
Ratio of waist to hip circumference - measured using anthropocentric tape
Measured: 6-weeks
Waist to hip ratio
Ratio of waist to hip circumference - measured using anthropocentric tape
Measured: 12-weeks
Blood glucose
Capillary blood glucose - mmol/L
Measured: Baseline
Blood glucose
Capillary blood glucose - mmol/L
Measured: 6-weeks
Blood glucose
Capillary blood glucose - mmol/L
Measured: 12-weeks
Blood triglycerides
Capillary blood triglycerides - mmol/L
Measured: Baseline
Blood triglycerides
Capillary blood triglycerides - mmol/L
Measured: 6-weeks
Blood triglycerides
Capillary blood triglycerides - mmol/L
Measured: 12-weeks
Blood cholesterol
Capillary blood cholesterol - mmol/L
Measured: Baseline
Blood cholesterol
Capillary blood cholesterol - mmol/L
Measured: 6-weeks
Blood cholesterol
Capillary blood cholesterol - mmol/L
Measured: 12-weeks
Body mass
Body mass (kg)
Measured: Baseline
Body mass
Body mass (kg)
Measured: 6-weeks
Body mass
Body mass (kg)
Measured: 12-weeks
Body mass index
Body mass index kg/m2
Measured: Baseline
Body mass index
Body mass index kg/m2
Measured: 6-weeks
Body mass index
Body mass index kg/m2
Measured: 12-weeks
Waist circumference
Waist circumference (cm)
Measured: Baseline
Waist circumference
Waist circumference (cm)
Measured: 6-weeks
Waist circumference
Waist circumference (cm)
Measured: 12-weeks
Mediterranean Diet score
Mediterranean score obtained from the Mediterranean Diet Assessment tool. A lower score means higher risk from cardiovascular disease. The scale has a score range from 0-14.
Measured: Baseline
Mediterranean Diet score
Mediterranean score obtained from the Mediterranean Diet Assessment tool. A lower score means higher risk from cardiovascular disease. The scale has a score range from 0-14.
Measured: 6-weeks
Mediterranean Diet score
Mediterranean score obtained from the Mediterranean Diet Assessment tool. A lower score means higher risk from cardiovascular disease. The scale has a score range from 0-14.
Measured: 12-weeks
Total energy
Total daily energy (kcal) taken from a 4-day diet diary
Measured: Baseline
Total energy
Total daily energy (kcal) taken from a 4-day diet diary
Measured: 6-weeks
Total energy
Total daily energy (kcal) taken from a 4-day diet diary
Measured: 12-weeks
Calcium intake
Calcium intake per day (mg/day) taken from a 4-day diet diary
Measured: Baseline
Calcium intake
Calcium intake per day (mg/day) taken from a 4-day diet diary
Measured: 6-weeks
Calcium intake
Calcium intake per day (mg/day) taken from a 4-day diet diary
Measured: 12-weeks
Vitamin B12 intake
Vitamin B12 (ug) intake per day taken from a 4-day diet diary
Measured: Baseline
Vitamin B12 intake
Vitamin B12 (ug) intake per day taken from a 4-day diet diary
Measured: 6-weeks
Vitamin B12 intake
Vitamin B12 (ug) intake per day taken from a 4-day diet diary
Measured: 12-weeks
Vitamin B6 intake
Vitamin B6 (mg) intake per day taken from a 4-day diet diary
Measured: Baseline
Vitamin B6 intake
Vitamin B6 (mg) intake per day taken from a 4-day diet diary
Measured: 6-weeks
Vitamin B6 intake
Vitamin B6 (mg) intake per day taken from a 4-day diet diary
Measured: 12-weeks
Folate intake
Folate (ug) intake per day taken from a 4-day diet diary
Measured: Baseline
Folate intake
Folate (ug) intake per day taken from a 4-day diet diary
Measured: 6-weeks
Folate intake
Folate (ug) intake per day taken from a 4-day diet diary
Measured: 12-weeks
Vitamin A intake
Vitamin A (ug) intake per day taken from a 4-day diet diary
Measured: Baseline
Vitamin A intake
Vitamin A (ug) intake per day taken from a 4-day diet diary
Measured: 6-weeks
Vitamin A intake
Vitamin A (ug) intake per day taken from a 4-day diet diary
Measured: 12-weeks
Vitamin C intake
Vitamin C (mg) intake per day taken from a 4-day diet diary
Measured: Baseline
Vitamin C intake
Vitamin C (mg) intake per day taken from a 4-day diet diary
Measured: 6-weeks
Vitamin C intake
Vitamin C (mg) intake per day taken from a 4-day diet diary
Measured: 12-weeks
Vitamin D intake
Vitamin D (ug) intake per day taken from a 4-day diet diary
Measured: Baseline
Vitamin D intake
Vitamin D (ug) intake per day taken from a 4-day diet diary
Measured: 6-weeks
Vitamin D intake
Vitamin D (ug) intake per day taken from a 4-day diet diary
Measured: 12-weeks
Vitamin E intake
Vitamin E (mg) intake per day taken from a 4-day diet diary
Measured: Baseline
Vitamin E intake
Vitamin E (mg) intake per day taken from a 4-day diet diary
Measured: 6-weeks
Vitamin E intake
Vitamin E (mg) intake per day taken from a 4-day diet diary
Measured: 12-weeks
Thiamine intake
Thiamine (mg) intake per day taken from a 4-day diet diary
Measured: Baseline
Thiamine intake
Thiamine (mg) intake per day taken from a 4-day diet diary
Measured: 6-weeks
Thiamine intake
Thiamine (mg) intake per day taken from a 4-day diet diary
Measured: 12-weeks
Riboflavin intake
Riboflavin (mg) intake per day taken from a 4-day diet diary
Measured: Baseline
Riboflavin intake
Riboflavin (mg) intake per day taken from a 4-day diet diary
Measured: 6-weeks
Riboflavin intake
Riboflavin (mg) intake per day taken from a 4-day diet diary
Measured: 12-weeks
Selenium intake
Selenium (ug) intake per day taken from a 4-day diet diary
Measured: Baseline
Selenium intake
Selenium (ug) intake per day taken from a 4-day diet diary
Measured: 6-weeks
Selenium intake
Selenium (ug) intake per day taken from a 4-day diet diary
Measured: 12-weeks
Zinc intake
Zinc (mg) intake per day taken from a 4-day diet diary
Measured: Baseline
Zinc intake
Zinc (mg) intake per day taken from a 4-day diet diary
Measured: 6-weeks
Zinc intake
Zinc (mg) intake per day taken from a 4-day diet diary
Measured: 12-weeks
Sodium intake
Sodium (mg) intake per day taken from a 4-day diet diary
Measured: Baseline
Sodium intake
Sodium (mg) intake per day taken from a 4-day diet diary
Measured: 6-weeks
Sodium intake
Sodium (mg) intake per day taken from a 4-day diet diary
Measured: 12-weeks
Carbohydrate intake
Carbohydrate (g) intake per day taken from a 4-day diet diary
Measured: Baseline
Carbohydrate intake
Carbohydrate (g) intake per day taken from a 4-day diet diary
Measured: 6-weeks
Carbohydrate intake
Carbohydrate (g) intake per day taken from a 4-day diet diary
Measured: 12-weeks
Fat intake
Fat (g) intake per day taken from a 4-day diet diary
Measured: Baseline
Fat intake
Fat (g) intake per day taken from a 4-day diet diary
Measured: 6-weeks
Fat intake
Fat (g) intake per day taken from a 4-day diet diary
Measured: 12-weeks
Sugar intake
Sugar (g) intake per day taken from a 4-day diet diary
Measured: Baseline
Sugar intake
Sugar (g) intake per day taken from a 4-day diet diary
Measured: 6-weeks
Sugar intake
Sugar (g) intake per day taken from a 4-day diet diary
Measured: 12-weeks
Fibre intake
Fibre (g) intake per day taken from a 4-day diet diary
Measured: Baseline
Fibre intake
Fibre (g) intake per day taken from a 4-day diet diary
Measured: 6-weeks
Fibre intake
Fibre (g) intake per day taken from a 4-day diet diary
Measured: 12-weeks
Starch intake
Starch (g) intake per day taken from a 4-day diet diary
Measured: Baseline
Starch intake
Starch (g) intake per day taken from a 4-day diet diary
Measured: 6-weeks
Starch intake
Starch (g) intake per day taken from a 4-day diet diary
Measured: 12-weeks
Protein intake
Protein (g) intake per day taken from a 4-day diet diary
Measured: Baseline
Protein intake
Protein (g) intake per day taken from a 4-day diet diary
Measured: 6-weeks
Protein intake
Protein (g) intake per day taken from a 4-day diet diary
Measured: 12-weeks
Saturated fat intake
Saturated fat (g) intake per day taken from a 4-day diet diary
Measured: Baseline
Saturated fat intake
Saturated fat (g) intake per day taken from a 4-day diet diary
Measured: 6-weeks
Saturated fat intake
Saturated fat (g) intake per day taken from a 4-day diet diary
Measured: 12-weeks
Monounsaturated fat intake
Monounsaturated fat (g) intake per day taken from a 4-day diet diary
Measured: Baseline
Monounsaturated fat intake
Monounsaturated fat (g) intake per day taken from a 4-day diet diary
Measured: 6-weeks
Monounsaturated fat intake
Monounsaturated fat (g) intake per day taken from a 4-day diet diary
Measured: 12-weeks
Polyunsaturated fat intake
Polyunsaturated fat (g) intake per day taken from a 4-day diet diary
Measured: Baseline
Polyunsaturated fat intake
Polyunsaturated fat (g) intake per day taken from a 4-day diet diary
Measured: 6-weeks
Polyunsaturated fat intake
Polyunsaturated fat (g) intake per day taken from a 4-day diet diary
Measured: 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start1 Jan 2018
- Primary completion1 Sep 2018
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiometabolic SyndromeStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonathan Sinclair
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jonathan Sinclair, University of Central Lancashire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05198024
- Sponsor's protocol ID
- Nutrition Education
- Status last verified
- Nov 2023
- First submitted
- 16 Dec 2021
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nutrition Education in Cardiac Rehabilitation Patients; a 3-arm Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05198024
- Acronym / sponsor ID
- Nutrition Education
- Conditions
- Cardiometabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Jonathan SinclairUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 20 Jan 2022 (actual)
- 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.
Coronary heart disease is one of the United Kingdom's biggest killers. In the UK alone 175,000 myocardial infarctions are recorded annually. To lower the financial burden on the National Health Service, cardiac rehabilitation facilitates a systematic and multidisciplinary approach to secondary prevention aimed to improve functional capacity and health-related quality of life, lower rehospitalisation rates and reduce all-cause and cardiovascular mortality with exercise training being the cornerstones. The effectiveness of
Cardiac rehabilitation programmes in delivering effective secondary prevention has long been established. Improvements are recorded in cardiovascular endurance, muscular strength and endurance, balance, co-ordination, and quality of life. However, many patients see little or no change in body mass and body mass index, an independent risk factor for coronary heart disease. Interestingly, the inclusion of nutrition education is rarely reported within specific Cardiac rehabilitation settings, therefore evidence of best practice remains elusive and warrants further investigation.
The aim of this trial is to compare:
- Usual care - Where patients access to two exercise classes per week and all facilities normally available as part of their cardiac rehabilitation programme. Patients in this group will undergo this approach for 12-weeks.
- Usual care + Biggest loser - In addition to Usual care, patients in this group took part in the 'Biggest loser' program in which the patients attended weekly sessions outside of their usual exercise class times. Each session follows a specific theme based on British Heart Foundation healthy eating guidelines. Participants will undergo this approach for 6-weeks and then switch to usual care for 6-weeks.
- Usual care + New Education programme. In addition to Usual care, the same weekly topics as the biggest loser are covered yet with bespoke information regarding portion sizes and recipes provided each week and patients given a challenge each week in relation to the topic being covered e.g. include more vegetables. Participants will undergo this approach for 6-weeks and then switch to usual care for 6-weeks.
Patients will be tested at baseline, 6-weeks and 12-weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual care | Placebo comparator | Behavioral: Nutrition knowledgeWhere patients access to two exercise classes per week and all facilities as part of their cardiac rehabilitation. In addition to this, patients in this group took part in the 'Biggest loser' program in which the patients attended weekly sessions outside of their usual exercise class times. Each session follows a specific theme based on British Heart Foundation healthy eating guidelines. Participants will undergo this approach for 6-weeks and then switch to usual care for 6-weeks. |
| Usual care plus biggest loser | Experimental | Behavioral: Nutrition knowledgeWhere patients access to two exercise classes per week and all facilities as part of their cardiac rehabilitation. In addition to this, patients in this group took part in the 'Biggest loser' program in which the patients attended weekly sessions outside of their usual exercise class times. Each session follows a specific theme based on British Heart Foundation healthy eating guidelines. Participants will undergo this approach for 6-weeks and then switch to usual care for 6-weeks. |
| Usual care plus new education programme | Experimental | Behavioral: Nutrition knowledgeWhere patients access to two exercise classes per week and all facilities as part of their cardiac rehabilitation. In addition to this, patients in this group too part in a new education programme (anecdotally referred to as "Healthy Heart Happy You") in which the same weekly topics as the biggest loser are covered yet with bespoke information regarding portion sizes and recipes provided each week and patients given a challenge each week in relation to the topic being covered e.g. include more vegetables. Participants will undergo this approach for 6-weeks and then switch to usual care for 6-weeks. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able to give informed consent
- Engaged in phase IV cardiac rehabilitation program
- Patient has read and understood the Patient Information Sheet
- Clinically stable (symptoms and medication)
Key exclusion criteria (1 listed)
- Clinically Unstable (symptoms and medication)
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 |
|---|---|---|
| Nutrition knowledgeNutrition knowledge either 'Usual care plus new education programme' or 'Usual care plus biggest loser' | Behavioural | Usual care, Usual care plus biggest loser, Usual care plus new education programme |
Primary outcome
Blood pressure
Time frame: Baseline
Systolic and diastolic blood pressure - measured using a digital blood pressure monitor
Blood pressure
Time frame: 6-weeks
Systolic and diastolic blood pressure - measured using a digital blood pressure monitor
Blood pressure
Time frame: 12-weeks
Systolic and diastolic blood pressure - measured using a digital blood pressure monitor
Waist to hip ratio
Time frame: Baseline
Ratio of waist to hip circumference - measured using anthropocentric tape
Waist to hip ratio
Time frame: 6-weeks
Ratio of waist to hip circumference - measured using anthropocentric tape
Waist to hip ratio
Time frame: 12-weeks
Ratio of waist to hip circumference - measured using anthropocentric tape
Blood glucose
Time frame: Baseline
Capillary blood glucose - mmol/L
Blood glucose
Time frame: 6-weeks
Capillary blood glucose - mmol/L
Blood glucose
Time frame: 12-weeks
Capillary blood glucose - mmol/L
Blood triglycerides
Time frame: Baseline
Capillary blood triglycerides - mmol/L
Blood triglycerides
Time frame: 6-weeks
Capillary blood triglycerides - mmol/L
Blood triglycerides
Time frame: 12-weeks
Capillary blood triglycerides - mmol/L
Blood cholesterol
Time frame: Baseline
Capillary blood cholesterol - mmol/L
Blood cholesterol
Time frame: 6-weeks
Capillary blood cholesterol - mmol/L
Blood cholesterol
Time frame: 12-weeks
Capillary blood cholesterol - mmol/L
Body mass
Time frame: Baseline
Body mass (kg)
Body mass
Time frame: 6-weeks
Body mass (kg)
Body mass
Time frame: 12-weeks
Body mass (kg)
Body mass index
Time frame: Baseline
Body mass index kg/m2
Body mass index
Time frame: 6-weeks
Body mass index kg/m2
Body mass index
Time frame: 12-weeks
Body mass index kg/m2
Waist circumference
Time frame: Baseline
Waist circumference (cm)
Waist circumference
Time frame: 6-weeks
Waist circumference (cm)
Waist circumference
Time frame: 12-weeks
Waist circumference (cm)
Mediterranean Diet score
Time frame: Baseline
Mediterranean score obtained from the Mediterranean Diet Assessment tool. A lower score means higher risk from cardiovascular disease. The scale has a score range from 0-14.
Mediterranean Diet score
Time frame: 6-weeks
Mediterranean score obtained from the Mediterranean Diet Assessment tool. A lower score means higher risk from cardiovascular disease. The scale has a score range from 0-14.
Mediterranean Diet score
Time frame: 12-weeks
Mediterranean score obtained from the Mediterranean Diet Assessment tool. A lower score means higher risk from cardiovascular disease. The scale has a score range from 0-14.
Total energy
Time frame: Baseline
Total daily energy (kcal) taken from a 4-day diet diary
Total energy
Time frame: 6-weeks
Total daily energy (kcal) taken from a 4-day diet diary
Total energy
Time frame: 12-weeks
Total daily energy (kcal) taken from a 4-day diet diary
Calcium intake
Time frame: Baseline
Calcium intake per day (mg/day) taken from a 4-day diet diary
Calcium intake
Time frame: 6-weeks
Calcium intake per day (mg/day) taken from a 4-day diet diary
Calcium intake
Time frame: 12-weeks
Calcium intake per day (mg/day) taken from a 4-day diet diary
Vitamin B12 intake
Time frame: Baseline
Vitamin B12 (ug) intake per day taken from a 4-day diet diary
Vitamin B12 intake
Time frame: 6-weeks
Vitamin B12 (ug) intake per day taken from a 4-day diet diary
Vitamin B12 intake
Time frame: 12-weeks
Vitamin B12 (ug) intake per day taken from a 4-day diet diary
Vitamin B6 intake
Time frame: Baseline
Vitamin B6 (mg) intake per day taken from a 4-day diet diary
Vitamin B6 intake
Time frame: 6-weeks
Vitamin B6 (mg) intake per day taken from a 4-day diet diary
Vitamin B6 intake
Time frame: 12-weeks
Vitamin B6 (mg) intake per day taken from a 4-day diet diary
Folate intake
Time frame: Baseline
Folate (ug) intake per day taken from a 4-day diet diary
Folate intake
Time frame: 6-weeks
Folate (ug) intake per day taken from a 4-day diet diary
Folate intake
Time frame: 12-weeks
Folate (ug) intake per day taken from a 4-day diet diary
Vitamin A intake
Time frame: Baseline
Vitamin A (ug) intake per day taken from a 4-day diet diary
Vitamin A intake
Time frame: 6-weeks
Vitamin A (ug) intake per day taken from a 4-day diet diary
Vitamin A intake
Time frame: 12-weeks
Vitamin A (ug) intake per day taken from a 4-day diet diary
Vitamin C intake
Time frame: Baseline
Vitamin C (mg) intake per day taken from a 4-day diet diary
Vitamin C intake
Time frame: 6-weeks
Vitamin C (mg) intake per day taken from a 4-day diet diary
Vitamin C intake
Time frame: 12-weeks
Vitamin C (mg) intake per day taken from a 4-day diet diary
Vitamin D intake
Time frame: Baseline
Vitamin D (ug) intake per day taken from a 4-day diet diary
Vitamin D intake
Time frame: 6-weeks
Vitamin D (ug) intake per day taken from a 4-day diet diary
Vitamin D intake
Time frame: 12-weeks
Vitamin D (ug) intake per day taken from a 4-day diet diary
Vitamin E intake
Time frame: Baseline
Vitamin E (mg) intake per day taken from a 4-day diet diary
Vitamin E intake
Time frame: 6-weeks
Vitamin E (mg) intake per day taken from a 4-day diet diary
Vitamin E intake
Time frame: 12-weeks
Vitamin E (mg) intake per day taken from a 4-day diet diary
Thiamine intake
Time frame: Baseline
Thiamine (mg) intake per day taken from a 4-day diet diary
Thiamine intake
Time frame: 6-weeks
Thiamine (mg) intake per day taken from a 4-day diet diary
Thiamine intake
Time frame: 12-weeks
Thiamine (mg) intake per day taken from a 4-day diet diary
Riboflavin intake
Time frame: Baseline
Riboflavin (mg) intake per day taken from a 4-day diet diary
Riboflavin intake
Time frame: 6-weeks
Riboflavin (mg) intake per day taken from a 4-day diet diary
Riboflavin intake
Time frame: 12-weeks
Riboflavin (mg) intake per day taken from a 4-day diet diary
Selenium intake
Time frame: Baseline
Selenium (ug) intake per day taken from a 4-day diet diary
Selenium intake
Time frame: 6-weeks
Selenium (ug) intake per day taken from a 4-day diet diary
Selenium intake
Time frame: 12-weeks
Selenium (ug) intake per day taken from a 4-day diet diary
Zinc intake
Time frame: Baseline
Zinc (mg) intake per day taken from a 4-day diet diary
Zinc intake
Time frame: 6-weeks
Zinc (mg) intake per day taken from a 4-day diet diary
Zinc intake
Time frame: 12-weeks
Zinc (mg) intake per day taken from a 4-day diet diary
Sodium intake
Time frame: Baseline
Sodium (mg) intake per day taken from a 4-day diet diary
Sodium intake
Time frame: 6-weeks
Sodium (mg) intake per day taken from a 4-day diet diary
Sodium intake
Time frame: 12-weeks
Sodium (mg) intake per day taken from a 4-day diet diary
Carbohydrate intake
Time frame: Baseline
Carbohydrate (g) intake per day taken from a 4-day diet diary
Carbohydrate intake
Time frame: 6-weeks
Carbohydrate (g) intake per day taken from a 4-day diet diary
Carbohydrate intake
Time frame: 12-weeks
Carbohydrate (g) intake per day taken from a 4-day diet diary
Fat intake
Time frame: Baseline
Fat (g) intake per day taken from a 4-day diet diary
Fat intake
Time frame: 6-weeks
Fat (g) intake per day taken from a 4-day diet diary
Fat intake
Time frame: 12-weeks
Fat (g) intake per day taken from a 4-day diet diary
Sugar intake
Time frame: Baseline
Sugar (g) intake per day taken from a 4-day diet diary
Sugar intake
Time frame: 6-weeks
Sugar (g) intake per day taken from a 4-day diet diary
Sugar intake
Time frame: 12-weeks
Sugar (g) intake per day taken from a 4-day diet diary
Fibre intake
Time frame: Baseline
Fibre (g) intake per day taken from a 4-day diet diary
Fibre intake
Time frame: 6-weeks
Fibre (g) intake per day taken from a 4-day diet diary
Fibre intake
Time frame: 12-weeks
Fibre (g) intake per day taken from a 4-day diet diary
Starch intake
Time frame: Baseline
Starch (g) intake per day taken from a 4-day diet diary
Starch intake
Time frame: 6-weeks
Starch (g) intake per day taken from a 4-day diet diary
Starch intake
Time frame: 12-weeks
Starch (g) intake per day taken from a 4-day diet diary
Protein intake
Time frame: Baseline
Protein (g) intake per day taken from a 4-day diet diary
Protein intake
Time frame: 6-weeks
Protein (g) intake per day taken from a 4-day diet diary
Protein intake
Time frame: 12-weeks
Protein (g) intake per day taken from a 4-day diet diary
Saturated fat intake
Time frame: Baseline
Saturated fat (g) intake per day taken from a 4-day diet diary
Saturated fat intake
Time frame: 6-weeks
Saturated fat (g) intake per day taken from a 4-day diet diary
Saturated fat intake
Time frame: 12-weeks
Saturated fat (g) intake per day taken from a 4-day diet diary
Monounsaturated fat intake
Time frame: Baseline
Monounsaturated fat (g) intake per day taken from a 4-day diet diary
Monounsaturated fat intake
Time frame: 6-weeks
Monounsaturated fat (g) intake per day taken from a 4-day diet diary
Monounsaturated fat intake
Time frame: 12-weeks
Monounsaturated fat (g) intake per day taken from a 4-day diet diary
Polyunsaturated fat intake
Time frame: Baseline
Polyunsaturated fat (g) intake per day taken from a 4-day diet diary
Polyunsaturated fat intake
Time frame: 6-weeks
Polyunsaturated fat (g) intake per day taken from a 4-day diet diary
Polyunsaturated fat intake
Time frame: 12-weeks
Polyunsaturated fat (g) intake per day taken from a 4-day diet diary
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 13 Nov 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition knowledge in people with Cardiometabolic Syndrome, run by Jonathan Sinclair 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 4 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 13 Nov 2023. 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. Some participants in this study may receive a placebo. 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?
Blood pressure (time frame: Baseline). The study lists 96 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Nov 2023.