Clinical trial NCT05764473: Diet, Cardiometabolic Risk (CM) and Menopause Symptoms
Official title: Dietary Patterns, Cardiometabolic Risk Factors and Menopause Symptoms in a Sample of UK Women - A Randomised Cross-over Parallel Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome, Protection Against
Menopause
Keywords: menopause
peri-menopause
post-menopause
vasomotor symptoms
cardiometabolic risk
Mediterranean Diet
MedDiet
Ultimate Cholesterol Lowering Plan
UCLP
Portfolio diet
diet quality
Lead sponsor: University of Chester
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 12
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 12-week randomised cross-over parallel trial
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* over the past year presented with any of the following

  1. Irregular periods or no periods at all
  2. Night sweats
  3. Hot flushes
  4. Sleeplessness
  5. Brain fog
  6. Increased anxiety
  7. Joint pain
  8. 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

Primary outcomes:
measure: Change Total cholesterol baseline-interim point
timeFrame: 6 weeks
measure: Change Total cholesterol baseline-endpoint
timeFrame: 12 weeks
measure: Change Total cholesterol interim point - endpoint
timeFrame: 6 weeks
measure: Change HDL cholesterol baseline - interim point
timeFrame: 6 weeks
measure: Change HDL cholesterol baseline - endpoint
timeFrame: 12 weeks
measure: Change HDL cholesterol interim point - endpoint
timeFrame: 6 weeks
measure: Change LDL cholesterol baseline-interim point
timeFrame: 6 weeks
measure: Change LDL cholesterol baseline - endpoint
timeFrame: 12 weeks
measure: Change LDL cholesterol interim point - endpoint
timeFrame: 6 weeks
measure: Change non-HDL cholesterol baseline - interim point
timeFrame: 6 weeks
measure: Change non-HDL cholesterol baseline - endpoint
timeFrame: 12 weeks
measure: Change non-HDL cholesterol interim point - endpoint
timeFrame: 6 weeks
measure: Change triglycerides baseline - interim point
timeFrame: 6 weeks
measure: Change triglycerides - baseline - endpoint
timeFrame: 12 weeks
measure: Change triglycerides interim point - endpoint
timeFrame: 6 weeks
measure: Change blood glucose baseline - interim point
timeFrame: 6 weeks
measure: Change blood glucose baseline - endpoint
timeFrame: 12 weeks
measure: Change blood glucose interim point - endpoint
timeFrame: 6 weeks
measure: Change Systolic and diastolic blood pressure baseline - interim point
timeFrame: 6 weeks
measure: Change Systolic and diastolic blood pressure baseline - endpoint
timeFrame: 12 weeks
measure: Change Systolic and diastolic blood pressure - interim point - endpoint
timeFrame: 6 weeks
measure: Change Body mass index - baseline - interim point
timeFrame: 6 weeks
measure: Change Body mass index baseline - endpoint
timeFrame: 12 weeks
measure: Change Body mass index - interim point - endpoint
timeFrame: 6 weeks
measure: Change Waist circumference baseline - interim point
timeFrame: 6 weeks
measure: Change Waist circumference baseline - endpoint
timeFrame: 12 weeks
measure: Change Waist circumference interim point - endpoint
timeFrame: 6 weeks
measure: Change Waist-hip ratio baseline - interim point
timeFrame: 6 weeks
measure: Change Waist-hip ratio baseline - endpoint
timeFrame: 12 weeks
measure: Change Waist-hip ratio interim point - endpoint
timeFrame: 6 weeks
measure: Change Waist-height ratio baseline - interim point
timeFrame: 6 weeks
measure: Change Waist-height ratio baseline - endpoint
timeFrame: 12 weeks
measure: Change Waist-height ratio interim point - endpoint
timeFrame: 6 weeks
Secondary outcomes:
measure: Change Frequency of menopause symptoms baseline - interim point
timeFrame: 6 weeks
measure: Change Frequency of menopause symptoms baseline - endpoint
timeFrame: 12 weeks
measure: Change Frequency of menopause symptoms - interim point - endpoint
timeFrame: 6 weeks
measure: Change Severity of menopause symptoms baseline - interim point
timeFrame: 6 weeks
measure: Change Severity of menopause symptoms baseline - endpoint
timeFrame: 12 weeks
measure: Change Severity of menopause symptoms interim point - endpoint
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Chester
country: United Kingdom
facility: University of Chester
state: Cheshire
Study officials:
affiliation: University of Chester
name: Tanja Harrison, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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