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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05417698
Other study ID # RIO 035-20
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 15, 2022
Est. completion date August 15, 2025

Study information

Verified date June 2023
Source Swansea University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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).


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date August 15, 2025
Est. primary completion date August 15, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 45 Years to 65 Years
Eligibility 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

Study Design


Intervention

Other:
Exercise Only (Ex only)
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)
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.

Locations

Country Name City State
United Kingdom Swansea University Swansea

Sponsors (1)

Lead Sponsor Collaborator
Swansea University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visceral adiposity index (VAI) 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. Baseline to 8 weeks
Primary Inflammatory markers Assessed at baseline and post-intervention (Week 1 and Week 8). IL-6, CRP, IL-10, TNF-a will be assessed from fasting blood collected from the antecubital vein via venepuncture. Baseline to 8 weeks
Primary Blood lipid levels 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. Baseline to 8 weeks
Primary Blood pressure 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. Baseline to 8 weeks
Primary Insulin resistance index (HOMA-IR) 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. Baseline to 8 weeks
Secondary Circulatory levels of ghrelin 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. Baseline to 8 weeks
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