NCT04763291Active, not recruiting
Cardiovascular and InflammAging Study
Effects of Long-term Consumption of Two Plant-based Dietary Supplements on Cardiovascular Health and Low-grade Inflammation in the Elderly
Source: ClinicalTrials.gov · Last updated 1 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 2 Feb 2021
- Start date
- 1 Sept 2021
- Primary completion date
- 31 May 2026
- Lead sponsor
- Green Beat
- Diseases
- Obesity
- NCT number
- NCT04763291
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 1 Sept 2021 to the primary completion date, 31 May 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Age
- Age \<55 and \>80 years
Other
- 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
- Pregnancy
- Significant lifestyle changes, e.g. changes in diet or physical activity profile
Who the study is looking for
- 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.
Age in the registry: 55 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Otto Loewi Research Center, Section of Physiological Chemistry, Medical University of Graz Coordinator of this site? Confirm its status | Graz | Austria | Unknown status |
| Green Beat Coordinator of this site? Confirm its status | Graz | Austria | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.