Metabolic Syndrome, Protection AgainstNCT05764473
Diet, Cardiometabolic Risk (CM) and Menopause Symptoms
A study testing The impact of MedDiet on cardiometabolic risk factors and menopause symptoms and The impact of UCLP on cardiometabolic risk factors and menopause symptoms in people with Metabolic Syndrome, Protection Against and Menopause, run by University of Chester at 1 site in United Kingdom.
Trial summary
This research will explore the question 'What impact do the Mediterranean Diet (MedDiet) and the Heart UK Ultimate Cholesterol Lowering Plan (UCLP) Menopause have on cardiometabolic risk factors and the frequency and severity of menopause symptoms? This is a randomised cross-over parallel trial of 12 weeks duration. Read more about this study
- Who is it for?
- Ages 35 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Protection Against, Menopause
- What is being tested?
- The impact of MedDiet on cardiometabolic risk factors and menopause symptoms and The impact of UCLP on cardiometabolic risk factors and menopause symptoms
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Mar 2023to 31 Aug 2023
- 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 35 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- over the past year presented with any of the following
- Irregular periods or no periods at all
- Night sweats
- Hot flushes
- Sleeplessness
- Brain fog
Show all 9Show fewer
- Increased anxiety
- Joint pain
- Changes to hair or skin
Who cannot join
- Ever had an eating disorder
- Ever diagnosed with cardiovascular disease or type 2 diabetes
- Ever diagnosed with kidney disease
- Current smoker
- Triglyceride levels of ≥ 5.7 mmol/L at baseline
- Glucose levels of ≥ 7 mmol/L at baseline
- Diastolic blood pressure of ≥ 100 mmHg at baseline
- Systolic blood pressure of ≥ 160 mmHg at baseline
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dietary Patterns, Cardiometabolic Risk Factors and Menopause Symptoms in a Sample of UK Women - A Randomised Cross-over Parallel Trial
This research will explore the question 'What impact do the Mediterranean Diet (MedDiet) and the Heart UK Ultimate Cholesterol Lowering Plan (UCLP) Menopause have on cardiometabolic risk factors and the frequency and severity of menopause symptoms? This is a randomised cross-over parallel trial of 12 weeks duration. Participants are women undergoing or having completed the menopause transition.
Read the detailed description
Group 1 will first follow the MedDiet pattern for six weeks and then follow the UCLP diet pattern for six weeks. Group 2 will also follow both diet patterns but in the opposite order.
Week 0 will be the baseline, week 6 will be the interim point and week 12 will be the endpoint.
Data collection Some data will be collected at the University of Chester laboratories, including anthropometric measurements, blood pressure and blood samples. A small fasted blood sample will be collected via finger prick (Alere Cholestech LDX® Analyzer (Alere San Diego Inc. USA)). Participants will also be talked through the guidance notes for the diets at this point. Other data, food diaries and a questionnaire asking about recent physical activity and menopause symptoms will be completed online.
Demographics At baseline participants will be asked to complete a brief questionnaire to answer a few demographic questions, including date of birth, ethnicity, income category, level of education, whether (and if so which) using any form of hormone replacement therapy (HRT) or contraception. Participants will be asked at interim and endpoint whether there have been any recent changes with regards to HRT and contraception methods.
Dietary intake Participants will be asked to complete a total of seven four-day food diaries. The first diary will be completed in the week before participants attend their first appointment in the laboratory. This diary will give a snapshot of the participants' habitual diet prior to joining the intervention. The other four-day food diaries will be completed in weeks 2, 4, 6, 8, 10 and 12.
Physical activity Data on physical activity over the previous four-week period will be collected at baseline, interim point and endpoint. Participants will be asked to complete the Recent Physical Activity Questionnaire (RPAQ).
Data analysis Blood sample Blood samples will be used to assess whether participants have
- elevated total cholesterol levels (>5 mmol/L)
- elevated LDL cholesterol levels (>3.0 mmol/L)
- elevated non-HDL cholesterol levels (>4 mmol/L)
- decreased HDL cholesterol levels (<1.3 mmol/L)
- elevated triglyceride levels (>1.7 mmol/L)
- elevated glucose levels (> 5.6 mmol/L)
HDL-C, glucose and triglyceride levels will also be used together with waist circumference and blood pressure data to assess whether participants present with metabolic syndrome at baseline, interim point and endpoint according to the definition of Alberti et al. (2009)
Dietary intake Food diary data will be analysed using the dietary assessment software Nutritics (2021).
The data from the analysis will also be used to identify the intake of phytoestrogen-rich foods (associated with milder menopause symptoms) and the average intake of phytoestrogens.
Dietary adherence and diet quality Following on from the analysis of the food diaries adherence to the MedDiet will be assessed by applying the Mediterranean Diet Score.
Adherence to the UCLP Menopause will be assessed by applying an amended version of the Portfolio Diet Score. The scoring system will be slightly adjusted where there are differences in terms of amounts to be consumed of the four portfolio foods.
Physical activity Each activity across the four domains of the RPAQ has a MET score assigned based on Ainsworth et al.'s (2011) updated Compendium of Physical Activities to categorise the activity as sedentary, light, moderate or vigorous intensity. Recoding of the completed RPAQ will follow the script devised by Medical Research Council (MRC) Epidemiology Unit (Scott et al., 2013; available to download at www.mrc-epid.cam.ac.uk/physical-activity-downloads/).
Statistical analysis Descriptive statistics (means (M) and standard deviation (SD)) will be produced for all data collected. Data will also be analysed for correlations between dietary intake, diet quality and changes to cardiometabolic risk (CMR) and to menopause symptoms. Mixed ANOVAs and linear and logistic regression analysis will also be employed. If necessary data will be adjusted for factors, such as physical activity, ethnicity, HRT intake, contraceptive intake, educational level and income category.
- Conditions
- Metabolic Syndrome, Protection Against, Menopause
- Being tested
- The impact of MedDiet on cardiometabolic risk factors and menopause symptoms, The impact of UCLP on cardiometabolic risk factors and menopause symptoms
- Keywords
- menopause, peri-menopause, post-menopause, vasomotor symptoms, cardiometabolic risk, Mediterranean Diet, MedDiet, Ultimate Cholesterol Lowering Plan, UCLP, Portfolio diet, diet quality
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The impact of MedDiet on cardiometabolic risk factors and menopause symptomsOther
12-week randomised parallel cross-over study with 32 participants. Impact of diet on CMR factors and menopause symptoms will be explored with diet quality and adherence to diet determined via diet quality indices for MedDiet and Portfolio diet.
The impact of UCLP on cardiometabolic risk factors and menopause symptomsOther
12-week randomised parallel cross-over study with 32 participants. Impact of diet on CMR factors and menopause symptoms will be explored with diet quality and adherence to diet determined via diet quality indices for MedDiet and Portfolio diet.
| Study group | Role | What they receive |
|---|---|---|
| A (Med/UCLP) | Experimental | Following the Mediterranean Diet for six weeks, then following the Ultimate Cholesterol Lowering Plan for six weeks.
Food diaries collected at baseline, week 2, week 4, week 6, week 8, week 10, week 12.
Cardiometabolic risk markers, menopause symptoms and physical activity collected at baseline, week 6, week 12. Receives: Other: The impact of MedDiet on cardiometabolic risk factors and menopause symptoms; Other: The impact of UCLP on cardiometabolic risk factors and menopause symptoms |
| B (ULCP/Med) | Experimental | Following the Ultimate Cholesterol Lowering Plan for six weeks, then following the Mediterranean Diet for six weeks.
Food diaries collected at baseline, week 2, week 4, week 6, week 8, week 10, week 12.
Cardiometabolic risk markers, menopause symptoms and physical activity collected at baseline, week 6, week 12. Receives: Other: The impact of MedDiet on cardiometabolic risk factors and menopause symptoms; Other: The impact of UCLP on cardiometabolic risk factors and menopause symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Total cholesterol baseline-interim point
Change from baseline total cholesterol concentrations at 6 weeks
Measured: 6 weeks
Change Total cholesterol baseline-endpoint
Change from baseline total cholesterol concentrations at 12 weeks
Measured: 12 weeks
Change Total cholesterol interim point - endpoint
Change from interim point total cholesterol concentrations at 12 weeks
Measured: 6 weeks
Change HDL cholesterol baseline - interim point
Change from baseline HDL cholesterol concentrations at 6 weeks
Measured: 6 weeks
Change HDL cholesterol baseline - endpoint
Change from baseline HDL cholesterol concentrations at 12 weeks
Measured: 12 weeks
Change HDL cholesterol interim point - endpoint
Change from interim point HDL cholesterol concentrations at 12 weeks
Measured: 6 weeks
Change LDL cholesterol baseline-interim point
Change from baseline LDL cholesterol concentrations at 6 weeks
Measured: 6 weeks
Change LDL cholesterol baseline - endpoint
Change from baseline LDL cholesterol concentrations at 12 weeks
Measured: 12 weeks
Change LDL cholesterol interim point - endpoint
Change from interim point LDL cholesterol concentrations at 12 weeks
Measured: 6 weeks
Change non-HDL cholesterol baseline - interim point
Change from baseline non-HDL cholesterol concentrations at 6 weeks
Measured: 6 weeks
Change non-HDL cholesterol baseline - endpoint
Change from baseline non-HDL cholesterol concentrations at 12 weeks
Measured: 12 weeks
Change non-HDL cholesterol interim point - endpoint
Change from interim point non-HDL cholesterol concentrations at 12 weeks
Measured: 6 weeks
Change triglycerides baseline - interim point
Change from baseline triglyceride concentrations at 6 weeks
Measured: 6 weeks
Change triglycerides - baseline - endpoint
Change from baseline triglyceride concentrations at 12 weeks
Measured: 12 weeks
Change triglycerides interim point - endpoint
Change from interim point triglyceride concentrations at 12 weeks
Measured: 6 weeks
Change blood glucose baseline - interim point
Change from baseline blood glucose concentrations at 6 weeks
Measured: 6 weeks
Change blood glucose baseline - endpoint
Change from baseline blood glucose concentrations at 12 weeks
Measured: 12 weeks
Change blood glucose interim point - endpoint
Change from interim point blood glucose concentrations at 12 weeks
Measured: 6 weeks
Change Systolic and diastolic blood pressure baseline - interim point
Change from baseline systolic and diastolic blood pressure at 6 weeks
Measured: 6 weeks
Change Systolic and diastolic blood pressure baseline - endpoint
Change from baseline blood glucose concentrations at 12 weeks
Measured: 12 weeks
Change Systolic and diastolic blood pressure - interim point - endpoint
Change from interim point blood glucose concentrations at 12 weeks
Measured: 6 weeks
Change Body mass index - baseline - interim point
Change from baseline body mass index at 6 weeks
Measured: 6 weeks
Change Body mass index baseline - endpoint
Change from baseline body mass index at 12 weeks
Measured: 12 weeks
Change Body mass index - interim point - endpoint
Change from interim point body mass index at 12 weeks
Measured: 6 weeks
Change Waist circumference baseline - interim point
Change from baseline waist circumference at 6 weeks
Measured: 6 weeks
Change Waist circumference baseline - endpoint
Change from baseline waist circumference at 12 weeks
Measured: 12 weeks
Change Waist circumference interim point - endpoint
Change from interim point waist circumference at 12 weeks
Measured: 6 weeks
Change Waist-hip ratio baseline - interim point
Change from baseline waist-hip ratio at 6 weeks
Measured: 6 weeks
Change Waist-hip ratio baseline - endpoint
Change from baseline waist-hip ratio at 12 weeks
Measured: 12 weeks
Change Waist-hip ratio interim point - endpoint
Change from interim point waist-hip ratio at 12 weeks
Measured: 6 weeks
Change Waist-height ratio baseline - interim point
Change from baseline waist-height ratio at 6 weeks
Measured: 6 weeks
Change Waist-height ratio baseline - endpoint
Change from baseline waist-height ratio at 12 weeks
Measured: 12 weeks
Change Waist-height ratio interim point - endpoint
Change from interim point waist-height ratio at 12 weeks
Measured: 6 weeks
Secondary outcomes (6)
Change Frequency of menopause symptoms baseline - interim point
Change from baseline frequency of menopause symptoms at 6 weeks on a scale from 0 to 21 on the Greene Climacteric Scale. Higher Scores indicate higher frequency.
Measured: 6 weeks
Change Frequency of menopause symptoms baseline - endpoint
Change from baseline frequency of menopause symptoms at 12 weeks on a scale from 0 to 21 on the Greene Climacteric Scale. Higher Scores indicate higher frequency.
Measured: 12 weeks
Change Frequency of menopause symptoms - interim point - endpoint
Change from interim point frequency of menopause symptoms at 12 weeks on a scale from 0 to 21 on the Greene Climacteric Scale. Higher Scores indicate higher frequency.
Measured: 6 weeks
Change Severity of menopause symptoms baseline - interim point
Change from baseline severity of menopause symptoms at 6 weeks on a scale from 0 to 3 on the Greene Climacteric Scale. Higher Scores indicate higher severity.
Measured: 6 weeks
Change Severity of menopause symptoms baseline - endpoint
Change from baseline severity of menopause symptoms at 12 weeks on a scale from 0 to 3 on the Greene Climacteric Scale. Higher Scores indicate higher severity.
Measured: 12 weeks
Change Severity of menopause symptoms interim point - endpoint
Change from interim point severity of menopause symptoms at 12 weeks on a scale from 0 to 3 on the Greene Climacteric Scale. Higher Scores indicate higher severity.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start14 Mar 2023
- Primary completion30 Jun 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Metabolic Syndrome, Protection AgainstStudies 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
- Crossover
- Model description
- 12-week randomised cross-over parallel trial
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tanja Harrison, University of Chester
- Investigators
- Tanja Harrison, PhD, Principal investigator, University of Chester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764473
- Sponsor's protocol ID
- MenoUoC
- Status last verified
- Jun 2024
- First submitted
- 13 Feb 2023
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
El Khoudary SR, Aggarwal B, Beckie TM, Hodis HN, Johnson AE, Langer RD, Limacher MC, Manson JE, Stefanick ML, Allison MA; American Heart Association Prevention Science Committee of the Council on Epidemiology and Prevention; and Council on Cardiovascular and Stroke Nursing. Menopause Transition and Cardiovascular Disease Risk: Implications for Timing of Early Prevention: A Scientific Statement From the American Heart Association. Circulation. 2020 Dec 22;142(25):e506-e532. doi: 10.1161/CIR.0000000000000912. Epub 2020 Nov 30.
PubMed 33251828Gomez-Delgado F, Katsiki N, Lopez-Miranda J, Perez-Martinez P. Dietary habits, lipoprotein metabolism and cardiovascular disease: From individual foods to dietary patterns. Crit Rev Food Sci Nutr. 2021;61(10):1651-1669. doi: 10.1080/10408398.2020.1764487. Epub 2020 Jun 9.
PubMed 32515660Greene JG. Constructing a standard climacteric scale. Maturitas. 1998 May 20;29(1):25-31. doi: 10.1016/s0378-5122(98)00025-5.
PubMed 9643514Lobo RA, Gompel A. Management of menopause: a view towards prevention. Lancet Diabetes Endocrinol. 2022 Jun;10(6):457-470. doi: 10.1016/S2213-8587(21)00269-2. Epub 2022 May 5.
PubMed 35526556Roa-Diaz ZM, Raguindin PF, Bano A, Laine JE, Muka T, Glisic M. Menopause and cardiometabolic diseases: What we (don't) know and why it matters. Maturitas. 2021 Oct;152:48-56. doi: 10.1016/j.maturitas.2021.06.013. Epub 2021 Jul 2.
PubMed 34674807
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Patterns, Cardiometabolic Risk Factors and Menopause Symptoms in a Sample of UK Women - A Randomised Cross-over Parallel Trial
- ClinicalTrials.gov ID
- NCT05764473
- Acronym / sponsor ID
- MenoUoC
- Conditions
- Metabolic Syndrome, Protection Against, Menopause
- Keywords
- menopause, peri-menopause, post-menopause, vasomotor symptoms, cardiometabolic risk, Mediterranean Diet, MedDiet, Ultimate Cholesterol Lowering Plan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of ChesterUniversity, hospital or other
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 10 Mar 2023 (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.
This research will explore the question 'What impact do the Mediterranean Diet (MedDiet) and the Heart UK Ultimate Cholesterol Lowering Plan (UCLP) Menopause have on cardiometabolic risk factors and the frequency and severity of menopause symptoms? This is a randomised cross-over parallel trial of 12 weeks duration. Participants are women undergoing or having completed the menopause transition.
Detailed description
Group 1 will first follow the MedDiet pattern for six weeks and then follow the UCLP diet pattern for six weeks. Group 2 will also follow both diet patterns but in the opposite order.
Week 0 will be the baseline, week 6 will be the interim point and week 12 will be the endpoint.
Data collection Some data will be collected at the University of Chester laboratories, including anthropometric measurements, blood pressure and blood samples. A small fasted blood sample will be collected via finger prick (Alere Cholestech LDX® Analyzer (Alere San Diego Inc. USA)). Participants will also be talked through the guidance notes for the diets at this point. Other data, food diaries and a questionnaire asking about recent physical activity and menopause symptoms will be completed online.
Demographics At baseline participants will be asked to complete a brief questionnaire to answer a few demographic questions, including date of birth, ethnicity, income category, level of education, whether (and if so which) using any form of hormone replacement therapy (HRT) or contraception. Participants will be asked at interim and endpoint whether there have been any recent changes with regards to HRT and contraception methods.
Dietary intake Participants will be asked to complete a total of seven four-day food diaries. The first diary will be completed in the week before participants attend their first appointment in the laboratory. This diary will give a snapshot of the participants' habitual diet prior to joining the intervention. The other four-day food diaries will be completed in weeks 2, 4, 6, 8, 10 and 12.
Physical activity Data on physical activity over the previous four-week period will be collected at baseline, interim point and endpoint. Participants will be asked to complete the Recent Physical Activity Questionnaire (RPAQ).
Data analysis Blood sample Blood samples will be used to assess whether participants have
- elevated total cholesterol levels (>5 mmol/L)
- elevated LDL cholesterol levels (>3.0 mmol/L)
- elevated non-HDL cholesterol levels (>4 mmol/L)
- decreased HDL cholesterol levels (<1.3 mmol/L)
- elevated triglyceride levels (>1.7 mmol/L)
- elevated glucose levels (> 5.6 mmol/L)
HDL-C, glucose and triglyceride levels will also be used together with waist circumference and blood pressure data to assess whether participants present with metabolic syndrome at baseline, interim point and endpoint according to the definition of Alberti et al. (2009)
Dietary intake Food diary data will be analysed using the dietary assessment software Nutritics (2021).
The data from the analysis will also be used to identify the intake of phytoestrogen-rich foods (associated with milder menopause symptoms) and the average intake of phytoestrogens.
Dietary adherence and diet quality Following on from the analysis of the food diaries adherence to the MedDiet will be assessed by applying the Mediterranean Diet Score.
Adherence to the UCLP Menopause will be assessed by applying an amended version of the Portfolio Diet Score. The scoring system will be slightly adjusted where there are differences in terms of amounts to be consumed of the four portfolio foods.
Physical activity Each activity across the four domains of the RPAQ has a MET score assigned based on Ainsworth et al.'s (2011) updated Compendium of Physical Activities to categorise the activity as sedentary, light, moderate or vigorous intensity. Recoding of the completed RPAQ will follow the script devised by Medical Research Council (MRC) Epidemiology Unit (Scott et al., 2013; available to download at www.mrc-epid.cam.ac.uk/physical-activity-downloads/).
Statistical analysis Descriptive statistics (means (M) and standard deviation (SD)) will be produced for all data collected. Data will also be analysed for correlations between dietary intake, diet quality and changes to cardiometabolic risk (CMR) and to menopause symptoms. Mixed ANOVAs and linear and logistic regression analysis will also be employed. If necessary data will be adjusted for factors, such as physical activity, ethnicity, HRT intake, contraceptive intake, educational level and income category.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 12-week randomised cross-over parallel trial
| Arm | Type | Receives |
|---|---|---|
| A (Med/UCLP) | Experimental | Other: The impact of MedDiet on cardiometabolic risk factors and menopause symptoms, Other: The impact of UCLP on cardiometabolic risk factors and menopause symptomsFollowing the Mediterranean Diet for six weeks, then following the Ultimate Cholesterol Lowering Plan for six weeks. Food diaries collected at baseline, week 2, week 4, week 6, week 8, week 10, week 12. Cardiometabolic risk markers, menopause symptoms and physical activity collected at baseline, week 6, week 12. |
| B (ULCP/Med) | Experimental | Other: The impact of MedDiet on cardiometabolic risk factors and menopause symptoms, Other: The impact of UCLP on cardiometabolic risk factors and menopause symptomsFollowing the Ultimate Cholesterol Lowering Plan for six weeks, then following the Mediterranean Diet for six weeks. Food diaries collected at baseline, week 2, week 4, week 6, week 8, week 10, week 12. Cardiometabolic risk markers, menopause symptoms and physical activity collected at baseline, week 6, week 12. |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- over the past year presented with any of the following
Key exclusion criteria (8 listed)
- Ever had an eating disorder
- Ever diagnosed with cardiovascular disease or type 2 diabetes
- Ever diagnosed with kidney disease
- Current smoker
- Triglyceride levels of ≥ 5.7 mmol/L at baseline
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 |
|---|---|---|
| The impact of MedDiet on cardiometabolic risk factors and menopause symptoms12-week randomised parallel cross-over study with 32 participants. Impact of diet on CMR factors and menopause symptoms will be explored with diet quality and adherence to diet determined via diet quality indices for MedDiet and Portfolio diet. | Other | A (Med/UCLP), B (ULCP/Med) |
| The impact of UCLP on cardiometabolic risk factors and menopause symptoms12-week randomised parallel cross-over study with 32 participants. Impact of diet on CMR factors and menopause symptoms will be explored with diet quality and adherence to diet determined via diet quality indices for MedDiet and Portfolio diet. | Other | A (Med/UCLP), B (ULCP/Med) |
Primary outcome
Change Total cholesterol baseline-interim point
Time frame: 6 weeks
Change from baseline total cholesterol concentrations at 6 weeks
Change Total cholesterol baseline-endpoint
Time frame: 12 weeks
Change from baseline total cholesterol concentrations at 12 weeks
Change Total cholesterol interim point - endpoint
Time frame: 6 weeks
Change from interim point total cholesterol concentrations at 12 weeks
Change HDL cholesterol baseline - interim point
Time frame: 6 weeks
Change from baseline HDL cholesterol concentrations at 6 weeks
Change HDL cholesterol baseline - endpoint
Time frame: 12 weeks
Change from baseline HDL cholesterol concentrations at 12 weeks
Change HDL cholesterol interim point - endpoint
Time frame: 6 weeks
Change from interim point HDL cholesterol concentrations at 12 weeks
Change LDL cholesterol baseline-interim point
Time frame: 6 weeks
Change from baseline LDL cholesterol concentrations at 6 weeks
Change LDL cholesterol baseline - endpoint
Time frame: 12 weeks
Change from baseline LDL cholesterol concentrations at 12 weeks
Change LDL cholesterol interim point - endpoint
Time frame: 6 weeks
Change from interim point LDL cholesterol concentrations at 12 weeks
Change non-HDL cholesterol baseline - interim point
Time frame: 6 weeks
Change from baseline non-HDL cholesterol concentrations at 6 weeks
Change non-HDL cholesterol baseline - endpoint
Time frame: 12 weeks
Change from baseline non-HDL cholesterol concentrations at 12 weeks
Change non-HDL cholesterol interim point - endpoint
Time frame: 6 weeks
Change from interim point non-HDL cholesterol concentrations at 12 weeks
Change triglycerides baseline - interim point
Time frame: 6 weeks
Change from baseline triglyceride concentrations at 6 weeks
Change triglycerides - baseline - endpoint
Time frame: 12 weeks
Change from baseline triglyceride concentrations at 12 weeks
Change triglycerides interim point - endpoint
Time frame: 6 weeks
Change from interim point triglyceride concentrations at 12 weeks
Change blood glucose baseline - interim point
Time frame: 6 weeks
Change from baseline blood glucose concentrations at 6 weeks
Change blood glucose baseline - endpoint
Time frame: 12 weeks
Change from baseline blood glucose concentrations at 12 weeks
Change blood glucose interim point - endpoint
Time frame: 6 weeks
Change from interim point blood glucose concentrations at 12 weeks
Change Systolic and diastolic blood pressure baseline - interim point
Time frame: 6 weeks
Change from baseline systolic and diastolic blood pressure at 6 weeks
Change Systolic and diastolic blood pressure baseline - endpoint
Time frame: 12 weeks
Change from baseline blood glucose concentrations at 12 weeks
Change Systolic and diastolic blood pressure - interim point - endpoint
Time frame: 6 weeks
Change from interim point blood glucose concentrations at 12 weeks
Change Body mass index - baseline - interim point
Time frame: 6 weeks
Change from baseline body mass index at 6 weeks
Change Body mass index baseline - endpoint
Time frame: 12 weeks
Change from baseline body mass index at 12 weeks
Change Body mass index - interim point - endpoint
Time frame: 6 weeks
Change from interim point body mass index at 12 weeks
Change Waist circumference baseline - interim point
Time frame: 6 weeks
Change from baseline waist circumference at 6 weeks
Change Waist circumference baseline - endpoint
Time frame: 12 weeks
Change from baseline waist circumference at 12 weeks
Change Waist circumference interim point - endpoint
Time frame: 6 weeks
Change from interim point waist circumference at 12 weeks
Change Waist-hip ratio baseline - interim point
Time frame: 6 weeks
Change from baseline waist-hip ratio at 6 weeks
Change Waist-hip ratio baseline - endpoint
Time frame: 12 weeks
Change from baseline waist-hip ratio at 12 weeks
Change Waist-hip ratio interim point - endpoint
Time frame: 6 weeks
Change from interim point waist-hip ratio at 12 weeks
Change Waist-height ratio baseline - interim point
Time frame: 6 weeks
Change from baseline waist-height ratio at 6 weeks
Change Waist-height ratio baseline - endpoint
Time frame: 12 weeks
Change from baseline waist-height ratio at 12 weeks
Change Waist-height ratio interim point - endpoint
Time frame: 6 weeks
Change from interim point waist-height ratio at 12 weeks
6 secondary outcomes
Change Frequency of menopause symptoms baseline - interim point
Time frame: 6 weeks
Change Frequency of menopause symptoms baseline - endpoint
Time frame: 12 weeks
Change Frequency of menopause symptoms - interim point - endpoint
Time frame: 6 weeks
Change Severity of menopause symptoms baseline - interim point
Time frame: 6 weeks
Change Severity of menopause symptoms baseline - endpoint
Time frame: 12 weeks
Change Severity of menopause symptoms interim point - endpoint
Time frame: 6 weeks
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 28 Jun 2024.
- Results publication: PubMed 33251828El Khoudary SR, Aggarwal B, Beckie TM, Hodis HN, Johnson AE, Langer RD, Limacher MC, Manson JE, Stefanick ML, Allison MA; American Heart Association Prevention Science Committee of the Council on Epidemiology and Prevention; and Council on Cardiovascular and Stroke Nursing. Menopause Transition and Cardiovascular Disease Risk: Implications for Timing of Early Prevention: A Scientific Statement From the American Heart Association. Circulation. 2020 Dec 22;142(25):e506-e532. doi: 10.1161/CIR.0000000000000912. Epub 2020 Nov 30.
- Results publication: PubMed 32515660Gomez-Delgado F, Katsiki N, Lopez-Miranda J, Perez-Martinez P. Dietary habits, lipoprotein metabolism and cardiovascular disease: From individual foods to dietary patterns. Crit Rev Food Sci Nutr. 2021;61(10):1651-1669. doi: 10.1080/10408398.2020.1764487. Epub 2020 Jun 9.
- Results publication: PubMed 9643514Greene JG. Constructing a standard climacteric scale. Maturitas. 1998 May 20;29(1):25-31. doi: 10.1016/s0378-5122(98)00025-5.
- Results publication: PubMed 35526556Lobo RA, Gompel A. Management of menopause: a view towards prevention. Lancet Diabetes Endocrinol. 2022 Jun;10(6):457-470. doi: 10.1016/S2213-8587(21)00269-2. Epub 2022 May 5.
- Results publication: PubMed 34674807Roa-Diaz ZM, Raguindin PF, Bano A, Laine JE, Muka T, Glisic M. Menopause and cardiometabolic diseases: What we (don't) know and why it matters. Maturitas. 2021 Oct;152:48-56. doi: 10.1016/j.maturitas.2021.06.013. Epub 2021 Jul 2.
- Individual participant dataSharing planned: No
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Cognitive Change, Metabolic Syndrome, Protection Against
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.
Tanja Harrison, PhD principal investigator
University of Chester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The impact of MedDiet on cardiometabolic risk factors and menopause symptoms and The impact of UCLP on cardiometabolic risk factors and menopause symptoms in people with Metabolic Syndrome, Protection Against and Menopause, run by University of Chester 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 9 inclusion and 8 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 28 Jun 2024. 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?
Change Total cholesterol baseline-interim point (time frame: 6 weeks). The study lists 33 primary outcomes in all. 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 NCT05764473, which also lists 5 linked publications.
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 28 Jun 2024.