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Diet, Cardiometabolic Risk (CM) and Menopause Symptoms

Primary Purpose

Metabolic Syndrome, Protection Against, Menopause

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
The impact of MedDiet on cardiometabolic risk factors and menopause symptoms
The impact of UCLP on cardiometabolic risk factors and menopause symptoms
Sponsored by
University of Chester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome, Protection Against focused on measuring menopause, peri-menopause, post-menopause, vasomotor symptoms, cardiometabolic risk, Mediterranean Diet, MedDiet, Ultimate Cholesterol Lowering Plan, UCLP, Portfolio diet, diet quality

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of ChesterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A (Med/UCLP)

B (ULCP/Med)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change Total cholesterol baseline-interim point
Change from baseline total cholesterol concentrations at 6 weeks
Change Total cholesterol baseline-endpoint
Change from baseline total cholesterol concentrations at 12 weeks
Change Total cholesterol interim point - endpoint
Change from interim point total cholesterol concentrations at 12 weeks
Change HDL cholesterol baseline - interim point
Change from baseline HDL cholesterol concentrations at 6 weeks
Change HDL cholesterol baseline - endpoint
Change from baseline HDL cholesterol concentrations at 12 weeks
Change HDL cholesterol interim point - endpoint
Change from interim point HDL cholesterol concentrations at 12 weeks
Change LDL cholesterol baseline-interim point
Change from baseline LDL cholesterol concentrations at 6 weeks
Change LDL cholesterol baseline - endpoint
Change from baseline LDL cholesterol concentrations at 12 weeks
Change LDL cholesterol interim point - endpoint
Change from interim point LDL cholesterol concentrations at 12 weeks
Change non-HDL cholesterol baseline - interim point
Change from baseline non-HDL cholesterol concentrations at 6 weeks
Change non-HDL cholesterol baseline - endpoint
Change from baseline non-HDL cholesterol concentrations at 12 weeks
Change non-HDL cholesterol interim point - endpoint
Change from interim point non-HDL cholesterol concentrations at 12 weeks
Change triglycerides baseline - interim point
Change from baseline triglyceride concentrations at 6 weeks
Change triglycerides - baseline - endpoint
Change from baseline triglyceride concentrations at 12 weeks
Change triglycerides interim point - endpoint
Change from interim point triglyceride concentrations at 12 weeks
Change blood glucose baseline - interim point
Change from baseline blood glucose concentrations at 6 weeks
Change blood glucose baseline - endpoint
Change from baseline blood glucose concentrations at 12 weeks
Change blood glucose interim point - endpoint
Change from interim point blood glucose concentrations at 12 weeks
Change Systolic and diastolic blood pressure baseline - interim point
Change from baseline systolic and diastolic blood pressure at 6 weeks
Change Systolic and diastolic blood pressure baseline - endpoint
Change from baseline blood glucose concentrations at 12 weeks
Change Systolic and diastolic blood pressure - interim point - endpoint
Change from interim point blood glucose concentrations at 12 weeks
Change Body mass index - baseline - interim point
Change from baseline body mass index at 6 weeks
Change Body mass index baseline - endpoint
Change from baseline body mass index at 12 weeks
Change Body mass index - interim point - endpoint
Change from interim point body mass index at 12 weeks
Change Waist circumference baseline - interim point
Change from baseline waist circumference at 6 weeks
Change Waist circumference baseline - endpoint
Change from baseline waist circumference at 12 weeks
Change Waist circumference interim point - endpoint
Change from interim point waist circumference at 12 weeks
Change Waist-hip ratio baseline - interim point
Change from baseline waist-hip ratio at 6 weeks
Change Waist-hip ratio baseline - endpoint
Change from baseline waist-hip ratio at 12 weeks
Change Waist-hip ratio interim point - endpoint
Change from interim point waist-hip ratio at 12 weeks
Change Waist-height ratio baseline - interim point
Change from baseline waist-height ratio at 6 weeks
Change Waist-height ratio baseline - endpoint
Change from baseline waist-height ratio at 12 weeks
Change Waist-height ratio interim point - endpoint
Change from interim point waist-height ratio at 12 weeks

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
February 13, 2023
Last Updated
April 24, 2023
Sponsor
University of Chester
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1. Study Identification

Unique Protocol Identification Number
NCT05764473
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 14, 2023 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Chester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
12-week randomised cross-over parallel trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A (Med/UCLP)
Arm Type
Experimental
Arm Description
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.
Arm Title
B (ULCP/Med)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
The impact of MedDiet on cardiometabolic risk factors and menopause symptoms
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
The impact of UCLP on cardiometabolic risk factors and menopause symptoms
Intervention Description
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 Outcome Measure Information:
Title
Change Total cholesterol baseline-interim point
Description
Change from baseline total cholesterol concentrations at 6 weeks
Time Frame
6 weeks
Title
Change Total cholesterol baseline-endpoint
Description
Change from baseline total cholesterol concentrations at 12 weeks
Time Frame
12 weeks
Title
Change Total cholesterol interim point - endpoint
Description
Change from interim point total cholesterol concentrations at 12 weeks
Time Frame
6 weeks
Title
Change HDL cholesterol baseline - interim point
Description
Change from baseline HDL cholesterol concentrations at 6 weeks
Time Frame
6 weeks
Title
Change HDL cholesterol baseline - endpoint
Description
Change from baseline HDL cholesterol concentrations at 12 weeks
Time Frame
12 weeks
Title
Change HDL cholesterol interim point - endpoint
Description
Change from interim point HDL cholesterol concentrations at 12 weeks
Time Frame
6 weeks
Title
Change LDL cholesterol baseline-interim point
Description
Change from baseline LDL cholesterol concentrations at 6 weeks
Time Frame
6 weeks
Title
Change LDL cholesterol baseline - endpoint
Description
Change from baseline LDL cholesterol concentrations at 12 weeks
Time Frame
12 weeks
Title
Change LDL cholesterol interim point - endpoint
Description
Change from interim point LDL cholesterol concentrations at 12 weeks
Time Frame
6 weeks
Title
Change non-HDL cholesterol baseline - interim point
Description
Change from baseline non-HDL cholesterol concentrations at 6 weeks
Time Frame
6 weeks
Title
Change non-HDL cholesterol baseline - endpoint
Description
Change from baseline non-HDL cholesterol concentrations at 12 weeks
Time Frame
12 weeks
Title
Change non-HDL cholesterol interim point - endpoint
Description
Change from interim point non-HDL cholesterol concentrations at 12 weeks
Time Frame
6 weeks
Title
Change triglycerides baseline - interim point
Description
Change from baseline triglyceride concentrations at 6 weeks
Time Frame
6 weeks
Title
Change triglycerides - baseline - endpoint
Description
Change from baseline triglyceride concentrations at 12 weeks
Time Frame
12 weeks
Title
Change triglycerides interim point - endpoint
Description
Change from interim point triglyceride concentrations at 12 weeks
Time Frame
6 weeks
Title
Change blood glucose baseline - interim point
Description
Change from baseline blood glucose concentrations at 6 weeks
Time Frame
6 weeks
Title
Change blood glucose baseline - endpoint
Description
Change from baseline blood glucose concentrations at 12 weeks
Time Frame
12 weeks
Title
Change blood glucose interim point - endpoint
Description
Change from interim point blood glucose concentrations at 12 weeks
Time Frame
6 weeks
Title
Change Systolic and diastolic blood pressure baseline - interim point
Description
Change from baseline systolic and diastolic blood pressure at 6 weeks
Time Frame
6 weeks
Title
Change Systolic and diastolic blood pressure baseline - endpoint
Description
Change from baseline blood glucose concentrations at 12 weeks
Time Frame
12 weeks
Title
Change Systolic and diastolic blood pressure - interim point - endpoint
Description
Change from interim point blood glucose concentrations at 12 weeks
Time Frame
6 weeks
Title
Change Body mass index - baseline - interim point
Description
Change from baseline body mass index at 6 weeks
Time Frame
6 weeks
Title
Change Body mass index baseline - endpoint
Description
Change from baseline body mass index at 12 weeks
Time Frame
12 weeks
Title
Change Body mass index - interim point - endpoint
Description
Change from interim point body mass index at 12 weeks
Time Frame
6 weeks
Title
Change Waist circumference baseline - interim point
Description
Change from baseline waist circumference at 6 weeks
Time Frame
6 weeks
Title
Change Waist circumference baseline - endpoint
Description
Change from baseline waist circumference at 12 weeks
Time Frame
12 weeks
Title
Change Waist circumference interim point - endpoint
Description
Change from interim point waist circumference at 12 weeks
Time Frame
6 weeks
Title
Change Waist-hip ratio baseline - interim point
Description
Change from baseline waist-hip ratio at 6 weeks
Time Frame
6 weeks
Title
Change Waist-hip ratio baseline - endpoint
Description
Change from baseline waist-hip ratio at 12 weeks
Time Frame
12 weeks
Title
Change Waist-hip ratio interim point - endpoint
Description
Change from interim point waist-hip ratio at 12 weeks
Time Frame
6 weeks
Title
Change Waist-height ratio baseline - interim point
Description
Change from baseline waist-height ratio at 6 weeks
Time Frame
6 weeks
Title
Change Waist-height ratio baseline - endpoint
Description
Change from baseline waist-height ratio at 12 weeks
Time Frame
12 weeks
Title
Change Waist-height ratio interim point - endpoint
Description
Change from interim point waist-height ratio at 12 weeks
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change Frequency of menopause symptoms baseline - interim point
Description
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.
Time Frame
6 weeks
Title
Change Frequency of menopause symptoms baseline - endpoint
Description
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.
Time Frame
12 weeks
Title
Change Frequency of menopause symptoms - interim point - endpoint
Description
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.
Time Frame
6 weeks
Title
Change Severity of menopause symptoms baseline - interim point
Description
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.
Time Frame
6 weeks
Title
Change Severity of menopause symptoms baseline - endpoint
Description
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.
Time Frame
12 weeks
Title
Change Severity of menopause symptoms interim point - endpoint
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tanja Harrison, PhD
Phone
01244511224
Email
t.harrison@chester.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tanja Harrison, PhD
Organizational Affiliation
University of Chester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chester
City
Chester
State/Province
Cheshire
ZIP/Postal Code
CH1 4BJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tanja Harrison, PhD
Phone
01244511224
Email
t.harrison@chester.ac.uk
First Name & Middle Initial & Last Name & Degree
Tanja Harrison, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33251828
Citation
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.
Results Reference
result
PubMed Identifier
32515660
Citation
Gomez-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 Reference
result
PubMed Identifier
9643514
Citation
Greene JG. Constructing a standard climacteric scale. Maturitas. 1998 May 20;29(1):25-31. doi: 10.1016/s0378-5122(98)00025-5.
Results Reference
result
PubMed Identifier
35526556
Citation
Lobo 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 Reference
result
PubMed Identifier
34674807
Citation
Roa-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.
Results Reference
result

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Diet, Cardiometabolic Risk (CM) and Menopause Symptoms

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