Cardiovascular and InflammAging Study
- Conditions
- AgingOverweight or ObesityCardiovascular Diseases
- Interventions
- Dietary Supplement: Juice Plus+ Fruit, Vegetable and Berry blendsDietary Supplement: Juice Plus+ Omega blend
- Registration Number
- NCT04763291
- Lead Sponsor
- Green Beat
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 112
- 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 <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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fruit, Vegetable, Berry and Omega (FVBO) group Juice Plus+ Omega blend Participants have to ingest an encapsulated juice powder concentrate along with a plant-based fatty acid supplement, otherwise continue their habitual diet and lifestyle. Fruit, Vegetable, Berry and Omega (FVBO) group Juice Plus+ Fruit, Vegetable and Berry blends Participants have to ingest an encapsulated juice powder concentrate along with a plant-based fatty acid supplement, otherwise continue their habitual diet and lifestyle. Fruit, Vegetable and Berry (FVB) group Juice Plus+ Fruit, Vegetable and Berry blends Participants have to ingest an encapsulated juice powder concentrate, otherwise continue their habitual diet and lifestyle. Omega group Juice Plus+ Omega blend Participants have to ingest a plant-based fatty acid supplement, otherwise continue their habitual diet and lifestyle.
- Primary Outcome Measures
Name Time Method Lipid profile markers 12 months Total cholesterol, HDL, LDL, ApoA1, triglycerides, Omega-3-Index
Concentration changes in cytokines/ cytokine receptors 12 months TNF-α, sTNFR1 and sTNFR2, CCL5 = RANTES, IL-1β, hsCRP, CCL2 = MCP-1, Osteoprotegerin (OPG), IL-5, IL-8
Glucose metabolism 12 months Glucose, insulin, HOMA-IR, HbA1c
Hemostasis markers 12 months Platelet aggregation, thrombelastometry, coagulation (Quick, PT, PTT)
Oxidative stress markers 12 months oxLDL, MDA, carbonyl proteins, (CP), redox state of albumin, homocysteine
- Secondary Outcome Measures
Name Time Method Vitamin K metabolism 12 months Osteocalcin, matrix Gla protein (MGP), vitamins K1 and K2 (MK-7)
mitochondrial DNA copy number (mtDNA-CN) 12 months mitochondrial DNA will be amplified and the ratio to genomic DNA will be calculated
Upper respiratory tract symptoms 12 months The number of symptoms experienced and severity of symptoms will be assessed by the Wisconsin upper respiratory symptoms survey (WURSS).
Quality of life Questionnaire 12 months Assessed through the Short Form Survey (SF-36), which consists of 8 scales, namely: physical functioning, physical role functioning, bodily pain, general health, vitality, social functioning, emotional role functioning, mental health. All items are scored on a scale from 0 to 100 and higher scores denote a more favourable health state.
Neurotrophins 12 months BDNF and NGF will be measured by ELISA
Cognitive function 12 months Cognitive function will be assessed by the CFD-index, which takes into account the following 5 dimensions: Attention (alertness, shared attention, processing speed), Verbal long-term memory, Executive functions (spatial working-memory, cognitive flexibility), Expressive language (word-fluency, object designation), Perceptual-motoric functions (visuoconstruction).
Trial Locations
- Locations (2)
Otto Loewi Research Center, Section of Physiological Chemistry, Medical University of Graz
🇦🇹Graz, Austria
Green Beat
🇦🇹Graz, Austria