Cardiovascular and InflammAging Study (NCT04763291) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Cardiovascular and InflammAging Study
Austria80 participantsStarted 2021-09-01
Plain-language summary
Evidence from previous studies supports a strong relationship between fruit and vegetable consumption and reduced cardiac risk. This could be mediated via improvements on blood pressure, platelet function and vascular reactivity. Certain vitamins and polyphenols found in fruits and vegetables, have antioxidant and anti-inflammatory effects and play a major role on the function of immune cells. Previous studies have also demonstrated the importance of omega-3 fatty acids on humans' health and their positive effects on the cardiovascular system and blood lipids regulation, as well as their involvement on inflammatory response. Nutritional regimens with adequate intake of micronutrients, fruit and vegetables, omega-3 fatty acids, low in sugar and saturated fats, such as the Mediterranean diet or vegetarian diets, can reduce chronic inflammation and oxidative stress and improve cardiovascular risk profile. Considering that the population's fruit and vegetable and omega-3 intakes are below recommendations, whole food-based supplements could provide an accessible form of supplementation to bridge the gap between actual and recommended intakes. This study is aiming to assess whether long-term separate ingestions of an encapsulated juice powder concentrate and a plant-based omega fatty acid supplement, or a combined ingestion of the two, can affect biomarkers of cardiovascular health, low-grade inflammation and indicators of biological aging in older adults.
Who can participate
Age range
55 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Post menopausal
* Non-smokers
* BMI 18.5 to 40 kg/m2
* Vegetable intake ≤ 2 servings/ day
* Intake of fruits ≤ 2 servings /day
* Adherence to a 6-week washout period for dietary supplements not ingested for specific medical conditions.
Exclusion Criteria:
* Age \<55 and \>80 years
* Smokers (or ex-smokers who quit smoking less than 3 years ago)
* Aversion to stop the intake of multivitamins, multiminerals or omega fatty acid supplements
* Subjects with histamine intolerance
* Hypertension, starting with grade 2 according to the classification of the European Society of Hypertension: systolic blood pressure \> 160mmHg, diastolic blood pressure \>100 mmHg
* All medication taken for less than 3 months or with changes on the dosage over the last 3 months and medication for any of the conditions listed below.
* Clinically relevant infectious diseases
* Diabetes mellitus type I and type II
* Rheumatic diseases
* Auto-immune diseases
* Any stents and coronary artery diseases (CAD)
* Cancer patients
* Pregnancy
* Significant lifestyle changes, e.g. changes in diet or physical activity profile
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Lipid profile markers
Timeframe: 12 months
2
Hemostasis markers
Timeframe: 12 months
3
Oxidative stress markers
Timeframe: 12 months
4
Glucose metabolism
Timeframe: 12 months
5
Concentration changes in cytokines/ cytokine receptors