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| Name | Class |
|---|---|
| Medical University of Graz | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Continue habitual diet and lifestyle. | |
| Fruit, Vegetable and Berry (FVB) group | Experimental | Participants have to ingest an encapsulated juice powder concentrate, otherwise continue their habitual diet and lifestyle. |
|
| Omega group | Experimental | Participants have to ingest a plant-based fatty acid supplement, otherwise continue their habitual diet and lifestyle. |
|
| Fruit, Vegetable, Berry and Omega (FVBO) group | Experimental | Participants have to ingest an encapsulated juice powder concentrate along with a plant-based fatty acid supplement, otherwise continue their habitual diet and lifestyle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Juice Plus+ Fruit, Vegetable and Berry blends | Dietary Supplement | Encapsulated juice powder concentrate derived from 36 dried fruits, vegetables and berries. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lipid profile markers | Total cholesterol, HDL, LDL, ApoA1, triglycerides, Omega-3-Index | 12 months |
| Hemostasis markers | Platelet aggregation, thrombelastometry, coagulation (Quick, PT, PTT) | 12 months |
| Oxidative stress markers | oxLDL, MDA, carbonyl proteins, (CP), redox state of albumin, homocysteine | 12 months |
| Glucose metabolism | Glucose, insulin, HOMA-IR, HbA1c | 12 months |
| Concentration changes in cytokines/ cytokine receptors | TNF-α, sTNFR1 and sTNFR2, CCL5 = RANTES, IL-1β, hsCRP, CCL2 = MCP-1, Osteoprotegerin (OPG), IL-5, IL-8 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Vitamin K metabolism | Osteocalcin, matrix Gla protein (MGP), vitamins K1 and K2 (MK-7) | 12 months |
| mitochondrial DNA copy number (mtDNA-CN) | mitochondrial DNA will be amplified and the ratio to genomic DNA will be calculated |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations of vitamins and carotenoids | Retinol, vitamins C, D, E (α-toc and γ-toc), α-carotene, β-carotene, lutein, zeaxanthin, lycopene, β-cryptoxanthin | 12 months |
| Plasma concentrations of fatty acids |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manfred Lamprecht, PhD | Green Beat | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Green Beat | Graz | 8042 | Austria | |||
| Otto Loewi Research Center, Section of Physiological Chemistry, Medical University of Graz |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37726820 | Derived | Tsiountsioura M, Cvirn G, Meixner-Goetz L, Ziegler T, Lamprecht M. Effects of long-term consumption of two plant-based dietary supplements on cardiovascular health and low-grade inflammation in middle-aged and elderly people: study protocol for a randomised, controlled trial. J Health Popul Nutr. 2023 Sep 19;42(1):100. doi: 10.1186/s41043-023-00434-x. |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D014675 | Vegetables |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Juice Plus+ Omega blend | Dietary Supplement | Encapsulated plant-based fatty acid supplement. |
|
| 12 months |
| Upper respiratory tract symptoms | The number of symptoms experienced and severity of symptoms will be assessed by the Wisconsin upper respiratory symptoms survey (WURSS). | 12 months |
| Quality of life Questionnaire | 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. | 12 months |
| Cognitive function | 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). | 12 months |
| Neurotrophins | BDNF and NGF will be measured by ELISA | 12 months |
Docosahexaenoic acid, docosapentaenoic acid, eicosapentaenoic acid, arachidonic acid, alphalinolenic acid, linoleic acid, oleic acid, palmitoleic acid, stearic acid.
| 12 months |
| Graz |
| Austria |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |