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AgingNCT04763291

Cardiovascular and InflammAging Study

A study testing Juice Plus+ Fruit, Vegetable and Berry blends and Juice Plus+ Omega blend in people with Aging and Cardiovascular Diseases, run by Green Beat at 2 sites in Austria.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 to 80 yearsHealthy volunteers can take part
What is being tested?
Juice Plus+ Fruit, Vegetable and Berry blends and Juice Plus+ Omega blend
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
2 sitesAustria
Study dates
1 Sep 2021to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Austria2 sites

  • Green Beat

    Graz, 8042

  • Otto Loewi Research Center, Section of Physiological Chemistry, Medical University of Graz

    Graz

Other trials in Austria

About this study

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

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.

Being tested
Juice Plus+ Fruit, Vegetable and Berry blends, Juice Plus+ Omega blend
Keywords
Aging, CVD prevention, Low-grade inflammation
Medical subject headings
Cardiovascular Diseases, Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Juice Plus+ Fruit, Vegetable and Berry blendsDietary supplement

    Encapsulated juice powder concentrate derived from 36 dried fruits, vegetables and berries.

  • Juice Plus+ Omega blendDietary supplement

    Encapsulated plant-based fatty acid supplement.

Study groups in NCT04763291
Study groupRoleWhat they receive
Control groupNo interventionContinue habitual diet and lifestyle.
Fruit, Vegetable and Berry (FVB) groupExperimentalParticipants have to ingest an encapsulated juice powder concentrate, otherwise continue their habitual diet and lifestyle.
Receives: Dietary Supplement: Juice Plus+ Fruit, Vegetable and Berry blends
Omega groupExperimentalParticipants have to ingest a plant-based fatty acid supplement, otherwise continue their habitual diet and lifestyle.
Receives: Dietary Supplement: Juice Plus+ Omega blend
Fruit, Vegetable, Berry and Omega (FVBO) groupExperimentalParticipants have to ingest an encapsulated juice powder concentrate along with a plant-based fatty acid supplement, otherwise continue their habitual diet and lifestyle.
Receives: Dietary Supplement: Juice Plus+ Fruit, Vegetable and Berry blends; Dietary Supplement: Juice Plus+ Omega blend

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lipid profile markers

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

    Measured: 12 months

  2. Hemostasis markers

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

    Measured: 12 months

  3. Oxidative stress markers

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

    Measured: 12 months

  4. Glucose metabolism

    Glucose, insulin, HOMA-IR, HbA1c

    Measured: 12 months

  5. 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

    Measured: 12 months

Secondary outcomes (6)

  1. Vitamin K metabolism

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

    Measured: 12 months

  2. mitochondrial DNA copy number (mtDNA-CN)

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

    Measured: 12 months

  3. Upper respiratory tract symptoms

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

    Measured: 12 months

  4. 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.

    Measured: 12 months

  5. 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).

    Measured: 12 months

  6. Neurotrophins

    BDNF and NGF will be measured by ELISA

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2021
  2. Study start1 Sep 2021
  3. Primary completionMay 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04763291
Sponsor's protocol ID
33-055 ex 20/21
Status last verified
Jun 2025
First submitted
2 Feb 2021
Last updated
1 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ziegler T, Darko A, Ledinski G, Kager G, Horl G, Seemann A, Cvirn G, Lamprecht M. Effects of a Commercial Fruit, Vegetable and Berry Juice Powder Concentrate on Metabolic Safety and Cardiovascular Health in Older Adults: 6-Month Results of a Randomized Controlled Trial. Nutrients. 2026 Aug 22;18(17):2746. doi: 10.3390/nu18172746.

    PubMed 42738920

  • 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.

    PubMed 37726820

Questions about this trial

What is this clinical trial studying?

A study testing Juice Plus+ Fruit, Vegetable and Berry blends and Juice Plus+ Omega blend in people with Aging and Cardiovascular Diseases, run by Green Beat at 2 sites in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lipid profile markers (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04763291, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.

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