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Evaluation of Lifestyle Modification on Cardiovascular Risk

NCT05417698 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-12-02

No results posted yet for this study

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.

Conditions

Interventions

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.

OTHER

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.

Sponsors & Collaborators

  • Swansea University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-15
Primary Completion
2025-08-15
Completion
2025-08-15

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05417698 on ClinicalTrials.gov