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NCT Number: NCT05417698

Evaluation of Lifestyle Modification on Cardiovascular Risk

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Metabolic Syndrome Body Weight Cardiovascular Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Menopause Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Type2diabetes

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Swansea University

Swansea, sa2 8pp, United Kingdom

About this study

This is a randomised-controlled study investigating the independent and combined effects of a home-based, equipment-free high intensity interval training (HIIT) exercise intervention with/without the Mediterranean diet (MedDiet) through ghrelin-mediated alteration on body composition, cardiovascular risk-related markers, metabolic markers and obesity-related hormones in postmenopausal women. The intervention will last for 8-weeks, with three arms comprising of 1) exercise only (Ex); 2) exercise and MedDiet (Ex+MedDiet); 3) control (no intervention).

Who can participate

Healthy volunteers accepted: Yes

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

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.

Exclusion criteria

  • Any inclusion criteria not met
  • Abnormal ECG
  • Current smokers
  • Current or history of substance abuse and/or excess alcohol intake
  • Cardiovascular disease
  • Cancer
  • Gastrointestinal disease e.g. inflammatory bowel disease or irritable bowel syndrome
  • Kidney disease
  • Liver disease
  • Pancreatitis
  • On hormone therapy for <6 months
  • Prescribed anti-hypertensive or beta-blocker medication

Treatment and study plan

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 least ≥80% of predicted heart rate maximum (HRmax; 220-age) during the high-intensity intervals, as well as at least 17 out of 20 Rate of Perceived Exertion on the Borg Scale.

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 the main source of fat. They will be encouraged to eat more oily and white fish, with moderate consumption of nuts, poultry and dairy products, and low consumption of red/processed meat and alcohol.

Participants will also perform 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 least ≥80% of predicted heart rate maximum (HRmax; 220-age) during the high-intensity intervals, as well as at least 17 out of 20 Rate of Perceived Exertion on the Borg Scale.

Primary outcomes

  1. Visceral adiposity index (VAI)

    Time frame: 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 venepuncture. Triglycerides and HDL will be recorded in mmol/L.

  2. Inflammatory markers

    Time frame: 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.

  3. Blood lipid levels

    Time frame: 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.

  4. Blood pressure

    Time frame: 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.

  5. Insulin resistance index (HOMA-IR)

    Time frame: 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.

Secondary outcomes

  1. Circulatory levels of ghrelin

    Time frame: Baseline to 8 weeks

    Assessed at baseline and post-intervention (Week 1 and Week 8). Fasting circulatory levels of acyl and des-acyl ghrelin will be assessed from fasting blood collected from the antecubital vein via venepuncture. Acyl and des-acyl ghrelin will be recorded in pg/mL.

Sponsors and collaborators

Lead sponsor

Swansea University

Other

Registry information

Official study title

Evaluation of Lifestyle Modification on Cardiovascular Risk in Overweight and Obese Postmenopausal Women: a Ghrelin-mediated Response

Acronym: GHRexD

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 14, 2022
Registry last updated
Dec 2, 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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