Clinical trial

Cardiovascular and InflammAging Study

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT04763291

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age55 Years to 80 Years

SexAll

Healthy volunteersAccepted

ConditionAging, Cardiovascular Diseases, Overweight or Obesity

Full registry criteria

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

Treatments and study arms

Juice Plus+ Fruit, Vegetable and Berry blends

Dietary Supplement

Encapsulated juice powder concentrate derived from 36 dried fruits, vegetables and berries.

Juice Plus+ Omega blend

Dietary Supplement

Encapsulated plant-based fatty acid supplement.

Primary outcomes

Lipid profile markers12 months

Total cholesterol, HDL, LDL, ApoA1, triglycerides, Omega-3-Index

Hemostasis markers12 months

Platelet aggregation, thrombelastometry, coagulation (Quick, PT, PTT)

Oxidative stress markers12 months

oxLDL, MDA, carbonyl proteins, (CP), redox state of albumin, homocysteine

Glucose metabolism12 months

Glucose, insulin, HOMA-IR, HbA1c

Concentration changes in cytokines/ cytokine receptors12 months

TNF-α, sTNFR1 and sTNFR2, CCL5 = RANTES, IL-1β, hsCRP, CCL2 = MCP-1, Osteoprotegerin (OPG), IL-5, IL-8

Study locations

2 locations were listed when this page was built. The first 40 are shown.

Green Beat🇦🇹 Graz, Austria

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Otto Loewi Research Center, Section of Physiological Chemistry, Medical University of Graz🇦🇹 Graz, Austria

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