Evaluation of Lifestyle Modification on Cardiovascular Risk

What this trial studies

This study proposes to examine the independent and combined effects of an 8-week home-based, equipment-free HIIT exercise intervention with/without Mediterranean diet through ghrelin-mediated alteration in overweight and obese metabolic women to improve cardiovascular-risk related markers and metabolic risk factors.

Conditions in scope

• Metabolic Syndrome
• Menopause
• Cardiovascular Diseases
• Obesity
• Type2diabetes

Interventions

• Exercise Only (Ex only) (Other) — Unsupervised, home-based, equipment-free high-intensity interval training of 20 minutes exercise performed 3 times a week, for a duration of 8-weeks. Participants will perform exercises to their own suitability in a progressive manner throughout the 8-weeks. Exercises will be exerted at…
• Exercise and Mediterranean Diet (Ex + MedDiet) (Other) — Participants in Ex+MedDiet arm adhere to a non-caloric restrictive Mediterranean diet throughout the 8-weeks comprising of a diet encompassing a focus on minimally processed food, incorporating a wide variety of fruits, vegetables, legumes and wholegrains, whilst utilising olive oil as…

Who can join

Women only · Ages 45 Years to 65 Years · Accepts healthy volunteers.

Inclusion criteria

• Female
• Participants \>45-65 years of age
• Body mass index (BMI) \>25.0 - 35.0
• Postmenopausal (with spontaneous amenorrhea for the last 12 months)
• Healthy (no known diseases)
• Physically inactive (IPAQ score - category I and not engaged in at least 60 min/week of structured exercise during the previous 6 months)
• Generally well enough to exercise.
• Abnormal ECG

Exclusion criteria

• See ClinicalTrials.gov for full exclusion criteria.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Active, not recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2022-08-15
• Primary completion: 2025-08-15
• Last update posted: 2024-12-02
• First posted: 2022-06-14

Sponsor & contact

Lead sponsor: Swansea University (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Visceral adiposity index (VAI) (Baseline to 8 weeks)
  Assessed at baseline and post-intervention (Week 1 and Week 8). VAI calculated based on their waist circumference, BMI, triglycerides and HDL cholesterol levels. Waist circumference will be recorded in centimetres. BMI will be combined based on weight (kilograms) and height (metres) as kg/m\^2. Triglycerides and HDL cholesterol levels will be assessed from fasting blood collected from the antecubital vein via…
• Inflammatory markers (Baseline to 8 weeks)
  Assessed at baseline and post-intervention (Week 1 and Week 8). IL-6, CRP, IL-10, TNF-α will be assessed from fasting blood collected from the antecubital vein via venepuncture.
• Blood lipid levels (Baseline to 8 weeks)
  Assessed at baseline and post-intervention (Week 1 and Week 8). Triglycerides, high-density lipoprotein (HDL), low-density lipoprotein (LDL), total cholesterol will be assessed from fasting blood collected from the antecubital vein via venepuncture. All blood lipids will be recorded in mmol/L.
• Blood pressure (Baseline to 8 weeks)
  Assessed at baseline and post-intervention (Week 1 and Week 8). Systolic and diastolic blood pressure will be obtained from the participant's left arm after resting for at least 10 minutes. Blood pressure will be recorded in mmHg.
• Insulin resistance index (HOMA-IR) (Baseline to 8 weeks)
  Assessed at baseline and post-intervention (Week 1 and Week 8). Calculated based on blood glucose levels (mmol/L) and insulin (pmol/L) from fasting blood collected from the antecubital vein via venepuncture.

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