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Completed

NCT Number: NCT05764473

Diet, Cardiometabolic Risk (CM) and Menopause Symptoms

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.

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Key information

Age range

35 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Chester

Chester, Cheshire, CH1 4BJ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • over the past year presented with any of the following
  • Irregular periods or no periods at all
  • Night sweats
  • Hot flushes
  • Sleeplessness
  • Brain fog
  • Increased anxiety
  • Joint pain
  • Changes to hair or skin

Exclusion criteria

  • 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

Treatment and study plan

The impact of MedDiet on cardiometabolic risk factors and menopause symptoms

Other

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 symptoms

Other

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.

Primary outcomes

  1. Change Total cholesterol baseline-interim point

    Time frame: 6 weeks

    Change from baseline total cholesterol concentrations at 6 weeks

  2. Change Total cholesterol baseline-endpoint

    Time frame: 12 weeks

    Change from baseline total cholesterol concentrations at 12 weeks

  3. Change Total cholesterol interim point - endpoint

    Time frame: 6 weeks

    Change from interim point total cholesterol concentrations at 12 weeks

  4. Change HDL cholesterol baseline - interim point

    Time frame: 6 weeks

    Change from baseline HDL cholesterol concentrations at 6 weeks

  5. Change HDL cholesterol baseline - endpoint

    Time frame: 12 weeks

    Change from baseline HDL cholesterol concentrations at 12 weeks

  6. Change HDL cholesterol interim point - endpoint

    Time frame: 6 weeks

    Change from interim point HDL cholesterol concentrations at 12 weeks

  7. Change LDL cholesterol baseline-interim point

    Time frame: 6 weeks

    Change from baseline LDL cholesterol concentrations at 6 weeks

  8. Change LDL cholesterol baseline - endpoint

    Time frame: 12 weeks

    Change from baseline LDL cholesterol concentrations at 12 weeks

  9. Change LDL cholesterol interim point - endpoint

    Time frame: 6 weeks

    Change from interim point LDL cholesterol concentrations at 12 weeks

  10. Change non-HDL cholesterol baseline - interim point

    Time frame: 6 weeks

    Change from baseline non-HDL cholesterol concentrations at 6 weeks

  11. Change non-HDL cholesterol baseline - endpoint

    Time frame: 12 weeks

    Change from baseline non-HDL cholesterol concentrations at 12 weeks

  12. Change non-HDL cholesterol interim point - endpoint

    Time frame: 6 weeks

    Change from interim point non-HDL cholesterol concentrations at 12 weeks

  13. Change triglycerides baseline - interim point

    Time frame: 6 weeks

    Change from baseline triglyceride concentrations at 6 weeks

  14. Change triglycerides - baseline - endpoint

    Time frame: 12 weeks

    Change from baseline triglyceride concentrations at 12 weeks

  15. Change triglycerides interim point - endpoint

    Time frame: 6 weeks

    Change from interim point triglyceride concentrations at 12 weeks

  16. Change blood glucose baseline - interim point

    Time frame: 6 weeks

    Change from baseline blood glucose concentrations at 6 weeks

  17. Change blood glucose baseline - endpoint

    Time frame: 12 weeks

    Change from baseline blood glucose concentrations at 12 weeks

  18. Change blood glucose interim point - endpoint

    Time frame: 6 weeks

    Change from interim point blood glucose concentrations at 12 weeks

  19. Change Systolic and diastolic blood pressure baseline - interim point

    Time frame: 6 weeks

    Change from baseline systolic and diastolic blood pressure at 6 weeks

  20. Change Systolic and diastolic blood pressure baseline - endpoint

    Time frame: 12 weeks

    Change from baseline blood glucose concentrations at 12 weeks

  21. Change Systolic and diastolic blood pressure - interim point - endpoint

    Time frame: 6 weeks

    Change from interim point blood glucose concentrations at 12 weeks

  22. Change Body mass index - baseline - interim point

    Time frame: 6 weeks

    Change from baseline body mass index at 6 weeks

  23. Change Body mass index baseline - endpoint

    Time frame: 12 weeks

    Change from baseline body mass index at 12 weeks

  24. Change Body mass index - interim point - endpoint

    Time frame: 6 weeks

    Change from interim point body mass index at 12 weeks

  25. Change Waist circumference baseline - interim point

    Time frame: 6 weeks

    Change from baseline waist circumference at 6 weeks

  26. Change Waist circumference baseline - endpoint

    Time frame: 12 weeks

    Change from baseline waist circumference at 12 weeks

  27. Change Waist circumference interim point - endpoint

    Time frame: 6 weeks

    Change from interim point waist circumference at 12 weeks

  28. Change Waist-hip ratio baseline - interim point

    Time frame: 6 weeks

    Change from baseline waist-hip ratio at 6 weeks

  29. Change Waist-hip ratio baseline - endpoint

    Time frame: 12 weeks

    Change from baseline waist-hip ratio at 12 weeks

  30. Change Waist-hip ratio interim point - endpoint

    Time frame: 6 weeks

    Change from interim point waist-hip ratio at 12 weeks

  31. Change Waist-height ratio baseline - interim point

    Time frame: 6 weeks

    Change from baseline waist-height ratio at 6 weeks

  32. Change Waist-height ratio baseline - endpoint

    Time frame: 12 weeks

    Change from baseline waist-height ratio at 12 weeks

  33. Change Waist-height ratio interim point - endpoint

    Time frame: 6 weeks

    Change from interim point waist-height ratio at 12 weeks

Secondary outcomes

  1. Change Frequency of menopause symptoms baseline - interim point

    Time frame: 6 weeks

    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.

  2. Change Frequency of menopause symptoms baseline - endpoint

    Time frame: 12 weeks

    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.

  3. Change Frequency of menopause symptoms - interim point - endpoint

    Time frame: 6 weeks

    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.

  4. Change Severity of menopause symptoms baseline - interim point

    Time frame: 6 weeks

    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.

  5. Change Severity of menopause symptoms baseline - endpoint

    Time frame: 12 weeks

    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.

  6. Change Severity of menopause symptoms interim point - endpoint

    Time frame: 6 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Chester

Other

Registry information

Official study title

Dietary Patterns, Cardiometabolic Risk Factors and Menopause Symptoms in a Sample of UK Women - A Randomised Cross-over Parallel Trial

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 10, 2023
Registry last updated
Jun 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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