Diet, Cardiometabolic Risk (CM) and Menopause Symptoms

NCT05764473 | Completed

• 1 other identifier: MenoUoC
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (33)

• Change Total cholesterol baseline-interim point

  Change from baseline total cholesterol concentrations at 6 weeks

  6 weeks

• Change Total cholesterol baseline-endpoint

  Change from baseline total cholesterol concentrations at 12 weeks

  12 weeks

• Change Total cholesterol interim point - endpoint

  Change from interim point total cholesterol concentrations at 12 weeks

  6 weeks

• Change HDL cholesterol baseline - interim point

  Change from baseline HDL cholesterol concentrations at 6 weeks

  6 weeks

• Change HDL cholesterol baseline - endpoint

  Change from baseline HDL cholesterol concentrations at 12 weeks

  12 weeks

• Change HDL cholesterol interim point - endpoint

  Change from interim point HDL cholesterol concentrations at 12 weeks

  6 weeks

• Change LDL cholesterol baseline-interim point

  Change from baseline LDL cholesterol concentrations at 6 weeks

  6 weeks

• Change LDL cholesterol baseline - endpoint

  Change from baseline LDL cholesterol concentrations at 12 weeks

  12 weeks

• Change LDL cholesterol interim point - endpoint

  Change from interim point LDL cholesterol concentrations at 12 weeks

  6 weeks

• Change non-HDL cholesterol baseline - interim point

  Change from baseline non-HDL cholesterol concentrations at 6 weeks

  6 weeks

• Change non-HDL cholesterol baseline - endpoint

  Change from baseline non-HDL cholesterol concentrations at 12 weeks

  12 weeks

• Change non-HDL cholesterol interim point - endpoint

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

  6 weeks

• Change triglycerides baseline - interim point

  Change from baseline triglyceride concentrations at 6 weeks

  6 weeks

• Change triglycerides - baseline - endpoint

  Change from baseline triglyceride concentrations at 12 weeks

  12 weeks

• Change triglycerides interim point - endpoint

  Change from interim point triglyceride concentrations at 12 weeks

  6 weeks

• Change blood glucose baseline - interim point

  Change from baseline blood glucose concentrations at 6 weeks

  6 weeks

• Change blood glucose baseline - endpoint

  Change from baseline blood glucose concentrations at 12 weeks

  12 weeks

• Change blood glucose interim point - endpoint

  Change from interim point blood glucose concentrations at 12 weeks

  6 weeks

• Change Systolic and diastolic blood pressure baseline - interim point

  Change from baseline systolic and diastolic blood pressure at 6 weeks

  6 weeks

• Change Systolic and diastolic blood pressure baseline - endpoint

  Change from baseline blood glucose concentrations at 12 weeks

  12 weeks

• Change Systolic and diastolic blood pressure - interim point - endpoint

  Change from interim point blood glucose concentrations at 12 weeks

  6 weeks

• Change Body mass index - baseline - interim point

  Change from baseline body mass index at 6 weeks

  6 weeks

• Change Body mass index baseline - endpoint

  Change from baseline body mass index at 12 weeks

  12 weeks

• Change Body mass index - interim point - endpoint

  Change from interim point body mass index at 12 weeks

  6 weeks

• Change Waist circumference baseline - interim point

  Change from baseline waist circumference at 6 weeks

  6 weeks

• Change Waist circumference baseline - endpoint

  Change from baseline waist circumference at 12 weeks

  12 weeks

• Change Waist circumference interim point - endpoint

  Change from interim point waist circumference at 12 weeks

  6 weeks

• Change Waist-hip ratio baseline - interim point

  Change from baseline waist-hip ratio at 6 weeks

  6 weeks

• Change Waist-hip ratio baseline - endpoint

  Change from baseline waist-hip ratio at 12 weeks

  12 weeks

• Change Waist-hip ratio interim point - endpoint

  Change from interim point waist-hip ratio at 12 weeks

  6 weeks

• Change Waist-height ratio baseline - interim point

  Change from baseline waist-height ratio at 6 weeks

  6 weeks

• Change Waist-height ratio baseline - endpoint

  Change from baseline waist-height ratio at 12 weeks

  12 weeks

• Change Waist-height ratio interim point - endpoint

  Change from interim point waist-height ratio at 12 weeks

  6 weeks

Secondary Outcomes (6)

• Change Frequency of menopause symptoms baseline - interim point

  6 weeks

• Change Frequency of menopause symptoms baseline - endpoint

  12 weeks

• Change Frequency of menopause symptoms - interim point - endpoint

  6 weeks

• Change Severity of menopause symptoms baseline - interim point

  6 weeks

• Change Severity of menopause symptoms baseline - endpoint

  12 weeks

Study Arms (2)

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.

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.

Other: The impact of MedDiet on cardiometabolic risk factors and menopause symptoms; Other: The impact of UCLP on cardiometabolic risk factors and menopause symptoms

Interventions

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.

A (Med/UCLP); B (ULCP/Med)

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.

A (Med/UCLP); B (ULCP/Med)

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chester: lead

Study Sites (1)

University of Chester

Chester, Cheshire, CH1 4BJ, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 33251828 RESULT

• 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.

  PMID: 32515660 RESULT

• Greene JG. Constructing a standard climacteric scale. Maturitas. 1998 May 20;29(1):25-31. doi: 10.1016/s0378-5122(98)00025-5.

  PMID: 9643514 RESULT

• 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.

  PMID: 35526556 RESULT

• 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.

  PMID: 34674807 RESULT

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Tanja Harrison, PhD

  University of Chester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Public Health Nutrition

Model Details: 12-week randomised cross-over parallel trial

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: March 10, 2023
• Study Start: March 14, 2023
• Primary Completion: June 30, 2023
• Study Completion: August 31, 2023
• Last Updated: June 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)