- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05417698
Evaluation of Lifestyle Modification on Cardiovascular Risk (GHRexD)
Evaluation of Lifestyle Modification on Cardiovascular Risk in Overweight and Obese Postmenopausal Women: a Ghrelin-mediated Response
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Swansea, United Kingdom, sa2 8pp
- Recruiting
- Swansea University
-
Contact:
- Rachel Churm
- Phone Number: +4401792604637
- Email: r.churm@swansea.ac.uk
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise only (Ex only)
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.
|
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.
|
Experimental: Exercise and Mediterranean Diet (Ex + MedDiet)
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. |
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. |
No Intervention: Control
Participants will be asked to maintain their diet and physical activity levels throughout the 8 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline to 8 weeks
|
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.
|
Baseline to 8 weeks
|
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.
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Baseline to 8 weeks
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Blood pressure
Time Frame: Baseline to 8 weeks
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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.
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Baseline to 8 weeks
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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.
|
Baseline to 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline to 8 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RIO 035-20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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