Evaluation of Lifestyle Modification on Cardiovascular Risk (GHRexD)

Swansea University

Status: Active, not recruiting

Conditions: Type2diabetes; Menopause; Obesity; Cardiovascular Diseases; Metabolic Syndrome

Treatments: Other: Exercise and Mediterranean Diet (Ex + MedDiet); Other: Exercise Only (Ex only)

Study type: Interventional

Funder types: Other

Identifiers

NCT05417698

RIO 035-20

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 estimated patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: 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.

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Exercise only (Ex only)

Experimental group

Description:

Participants in the "Exercise only" group will be performing home-based, equipment-free HIIT exercise for 20 minutes, 3 times a week for the duration of the 8-weeks, achieving ≥80% of predicted heart rate maximum (HRmax; 220-age) during the high-intensity intervals. Participants are also required to exercise at least 17 out of 20 on the Rate of Perceived Exertion (RPE) scale.

Treatment:

Other: Exercise Only (Ex only)

Exercise and Mediterranean Diet (Ex + MedDiet)

Experimental group

Description:

Participants in Ex+MedDiet arm will be required to adhere to a non-caloric restrictive Mediterranean diet throughout the 8-weeks according to a Mediterranean diet booklet provided by the researcher. In brief, diet encompasses 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 in this group will also be performing home-based, equipment-free HIIT exercise for 20 minutes, 3 times a week for the duration of the 8-weeks, achieving ≥80% of predicted heart rate maximum (HRmax; 220-age) during the high-intensity intervals. Participants are also required to exercise at least 17 out of 20 on the Rate of Perceived Exertion (RPE) scale.

Treatment:

Other: Exercise and Mediterranean Diet (Ex + MedDiet)

Control

No Intervention group

Description:

Participants will be asked to maintain their diet and physical activity levels throughout the 8 weeks.