Aging, Cardiovascular Diseases, Overweight or Obesity
Conditions
Keywords
Aging, CVD prevention, Low-grade inflammation
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.
Interventions
DIETARY_SUPPLEMENTJuice Plus+ Fruit, Vegetable and Berry blends
Encapsulated juice powder concentrate derived from 36 dried fruits, vegetables and berries.
DIETARY_SUPPLEMENTJuice Plus+ Omega blend
Encapsulated plant-based fatty acid supplement.
Sponsors
Medical University of Graz
Green Beat
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose metabolism | 12 months | Glucose, insulin, HOMA-IR, HbA1c |
| 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 |
| Lipid profile markers | 12 months | Total cholesterol, HDL, LDL, ApoA1, triglycerides, Omega-3-Index |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Plasma concentrations of vitamins and carotenoids | 12 months | Retinol, vitamins C, D, E (α-toc and γ-toc), α-carotene, β-carotene, lutein, zeaxanthin, lycopene, β-cryptoxanthin |
| Plasma concentrations of fatty acids | 12 months | Docosahexaenoic acid, docosapentaenoic acid, eicosapentaenoic acid, arachidonic acid, alphalinolenic acid, linoleic acid, oleic acid, palmitoleic acid, stearic acid. |
Countries
Austria
Outcome results
None listed