Cardiovascular and InflammAging Study

NCT ID: NCT04763291

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2026-12-31

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.

Conditions

Aging; Cardiovascular Diseases; Overweight or Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control group

Continue habitual diet and lifestyle.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Fruit, Vegetable and Berry (FVB) group

Participants have to ingest an encapsulated juice powder concentrate, otherwise continue their habitual diet and lifestyle.

Group Type: EXPERIMENTAL

Juice Plus+ Fruit, Vegetable and Berry blends

Intervention Type: DIETARY_SUPPLEMENT

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

Omega group

Participants have to ingest a plant-based fatty acid supplement, otherwise continue their habitual diet and lifestyle.

Group Type: EXPERIMENTAL

Juice Plus+ Omega blend

Intervention Type: DIETARY_SUPPLEMENT

Encapsulated plant-based fatty acid supplement.

Fruit, Vegetable, Berry and Omega (FVBO) group

Participants have to ingest an encapsulated juice powder concentrate along with a plant-based fatty acid supplement, otherwise continue their habitual diet and lifestyle.

Group Type: EXPERIMENTAL

Juice Plus+ Fruit, Vegetable and Berry blends

Intervention Type: DIETARY_SUPPLEMENT

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

Juice Plus+ Omega blend

Intervention Type: DIETARY_SUPPLEMENT

Encapsulated plant-based fatty acid supplement.

Interventions

Juice Plus+ Fruit, Vegetable and Berry blends

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

Intervention Type: DIETARY_SUPPLEMENT

Juice Plus+ Omega blend

Encapsulated plant-based fatty acid supplement.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Graz

OTHER

Sponsor Role: collaborator

Green Beat

OTHER

Sponsor Role: lead

Responsible Party

Lamprecht Manfred PhD, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manfred Lamprecht, PhD

Role: PRINCIPAL_INVESTIGATOR

Green Beat

Locations

Green Beat

Graz, , Austria

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

Graz, , Austria

Countries

Austria

References

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.

Reference Type: DERIVED

PMID: 37726820 (View on PubMed)

Other Identifiers

33-055 ex 20/21

Identifier Type: -

Identifier Source: org_study_id