Cardiovascular and InflammAging Study

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Long-term Consumption of Two Plant-based Dietary Supplements on Cardiovascular Health and Low-grade Inflammation in the Elderly

Conditions
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Aging, Cardiovascular Diseases, Overweight or Obesity

Intervention / Treatment
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* Dietary Supplement: Juice Plus+ Fruit, Vegetable and Berry blends
* Dietary Supplement: Juice Plus+ Omega blend


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Continue habitual diet and lifestyle. | |
| Experimental: Fruit, Vegetable and Berry (FVB) group<br>Participants have to ingest an encapsulated juice powder concentrate, otherwise continue their habitual diet and lifestyle. | Dietary Supplement: Juice Plus+ Fruit, Vegetable and Berry blends<br>* Encapsulated juice powder concentrate derived from 36 dried fruits, vegetables and berries.<br>|
| Experimental: Omega group<br>Participants have to ingest a plant-based fatty acid supplement, otherwise continue their habitual diet and lifestyle. | Dietary Supplement: Juice Plus+ Omega blend<br>* Encapsulated plant-based fatty acid supplement.<br>|
| Experimental: Fruit, Vegetable, Berry and Omega (FVBO) group<br>Participants have to ingest an encapsulated juice powder concentrate along with a plant-based fatty acid supplement, otherwise continue their habitual diet and lifestyle. | Dietary Supplement: Juice Plus+ Fruit, Vegetable and Berry blends<br>* Encapsulated juice powder concentrate derived from 36 dried fruits, vegetables and berries.<br>Dietary Supplement: Juice Plus+ Omega blend<br>* Encapsulated plant-based fatty acid supplement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aging, CVD prevention, Low-grade inflammation