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Active, Not Recruiting

NCT Number: NCT04763291

Cardiovascular and InflammAging Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Aging Body Weight Cardiovascular Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight or Obesity Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Green Beat, Graz, Austria

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. Lipid profile markers

    Time frame: 12 months

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

  2. Hemostasis markers

    Time frame: 12 months

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

  3. Oxidative stress markers

    Time frame: 12 months

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

  4. Glucose metabolism

    Time frame: 12 months

    Glucose, insulin, HOMA-IR, HbA1c

  5. Concentration changes in cytokines/ cytokine receptors

    Time frame: 12 months

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

Secondary outcomes

  1. Vitamin K metabolism

    Time frame: 12 months

    Osteocalcin, matrix Gla protein (MGP), vitamins K1 and K2 (MK-7)

  2. mitochondrial DNA copy number (mtDNA-CN)

    Time frame: 12 months

    mitochondrial DNA will be amplified and the ratio to genomic DNA will be calculated

  3. Upper respiratory tract symptoms

    Time frame: 12 months

    The number of symptoms experienced and severity of symptoms will be assessed by the Wisconsin upper respiratory symptoms survey (WURSS).

  4. Quality of life Questionnaire

    Time frame: 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.

  5. Cognitive function

    Time frame: 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).

  6. Neurotrophins

    Time frame: 12 months

    BDNF and NGF will be measured by ELISA

Other outcomes

  1. Plasma concentrations of vitamins and carotenoids

    Time frame: 12 months

    Retinol, vitamins C, D, E (α-toc and γ-toc), α-carotene, β-carotene, lutein, zeaxanthin, lycopene, β-cryptoxanthin

  2. Plasma concentrations of fatty acids

    Time frame: 12 months

    Docosahexaenoic acid, docosapentaenoic acid, eicosapentaenoic acid, arachidonic acid, alphalinolenic acid, linoleic acid, oleic acid, palmitoleic acid, stearic acid.

Sponsors and collaborators

Lead sponsor

Green Beat

Other

Collaborators

  • Medical University of Graz

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Feb 21, 2021
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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