Metabolic SyndromeGHRexDNCT05417698
Evaluation of Lifestyle Modification on Cardiovascular Risk
A study testing Exercise Only (Ex only) and Exercise and Mediterranean Diet (Ex + MedDiet) in people with Metabolic Syndrome and Menopause, run by Swansea University at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Menopause, Cardiovascular Diseases
- What is being tested?
- Exercise Only (Ex only) and Exercise and Mediterranean Diet (Ex + MedDiet)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Aug 2022to 15 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Any inclusion criteria not met
- Abnormal ECG
- Current smokers
- Current or history of substance abuse and/or excess alcohol intake
- Cardiovascular disease
- Cancer
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Lifestyle Modification on Cardiovascular Risk in Overweight and Obese Postmenopausal Women: a Ghrelin-mediated Response
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.
Read the detailed 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).
- Conditions
- Metabolic Syndrome, Menopause, Cardiovascular Diseases, Obesity, Type2diabetes
- Being tested
- Exercise Only (Ex only), Exercise and Mediterranean Diet (Ex + MedDiet)
- Keywords
- Ghrelin, Postmenopause
- Medical subject headings
- Metabolic Syndrome, Cardiovascular Diseases, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise only (Ex only) | Experimental | 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. Receives: Other: Exercise Only (Ex only) |
| Exercise and Mediterranean Diet (Ex + MedDiet) | Experimental | 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. Receives: Other: Exercise and Mediterranean Diet (Ex + MedDiet) |
| Control | No intervention | Participants will be asked to maintain their diet and physical activity levels throughout the 8 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 8 weeks
Inflammatory markers
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.
Measured: Baseline to 8 weeks
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.
Measured: Baseline to 8 weeks
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.
Measured: Baseline to 8 weeks
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.
Measured: Baseline to 8 weeks
Secondary outcomes (1)
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.
Measured: Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start15 Aug 2022
- Primary completion15 Aug 2025 (estimated)
- Study completion15 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised-controlled
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swansea University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417698
- Sponsor's protocol ID
- RIO 035-20
- Acronym
- GHRexD
- Status last verified
- Nov 2024
- First submitted
- 11 Apr 2022
- Last updated
- 2 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Lifestyle Modification on Cardiovascular Risk in Overweight and Obese Postmenopausal Women: a Ghrelin-mediated Response
- ClinicalTrials.gov ID
- NCT05417698
- Acronym / sponsor ID
- GHRexD / RIO 035-20
- Conditions
- Metabolic Syndrome, Menopause, Cardiovascular Diseases, Obesity, Type2diabetes
- Keywords
- Ghrelin, Postmenopause
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Swansea UniversityUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 15 Aug 2025 (estimated)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 14 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomised-controlled
| Arm | Type | Receives |
|---|---|---|
| Exercise only (Ex only) | Experimental | Other: 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. |
| Exercise and Mediterranean Diet (Ex + MedDiet) | Experimental | Other: 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. |
| Control | No intervention | –Participants will be asked to maintain their diet and physical activity levels throughout the 8 weeks. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (12 listed)
- Any inclusion criteria not met
- Abnormal ECG
- Current smokers
- Current or history of substance abuse and/or excess alcohol intake
- Cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 only (Ex only) |
| 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. | Other | Exercise and Mediterranean Diet (Ex + MedDiet) |
Primary outcome
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.
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.
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.
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.
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.
1 secondary outcome
Circulatory levels of ghrelin
Time frame: Baseline to 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Only (Ex only) and Exercise and Mediterranean Diet (Ex + MedDiet) in people with Metabolic Syndrome and Menopause, run by Swansea University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visceral adiposity index (VAI) (time frame: Baseline to 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.