Cardiovascular and InflammAging Study

NCT04763291 | Active Not Recruiting

• 1 other identifier: 33-055 ex 20/21
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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

Keywords

Aging; CVD prevention; Low-grade inflammation

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• Vitamin K metabolism

  12 months

• mitochondrial DNA copy number (mtDNA-CN)

  12 months

• Upper respiratory tract symptoms

  12 months

• Quality of life Questionnaire

  12 months

• Cognitive function

  12 months

Other Outcomes (2)

• Plasma concentrations of vitamins and carotenoids

  12 months

• Plasma concentrations of fatty acids

  12 months

Study Arms (4)

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.

Dietary Supplement: Juice Plus+ Fruit, Vegetable and Berry blends

Omega group

EXPERIMENTAL

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

Dietary Supplement: Juice Plus+ Omega blend

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.

Dietary Supplement: Juice Plus+ Fruit, Vegetable and Berry blends; Dietary Supplement: Juice Plus+ Omega blend

Interventions

Juice Plus+ Fruit, Vegetable and Berry blends DIETARY_SUPPLEMENT

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

Fruit, Vegetable and Berry (FVB) group; Fruit, Vegetable, Berry and Omega (FVBO) group

Juice Plus+ Omega blend DIETARY_SUPPLEMENT

Encapsulated plant-based fatty acid supplement.

Fruit, Vegetable, Berry and Omega (FVBO) group; Omega group

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Green Beat: lead
• Medical University of Graz: collaborator

Study Sites (2)

Green Beat

Graz, 8042, Austria

Location

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

Graz, Austria

Location

Related Publications (1)

• 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.

  PMID: 37726820 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Overweight; Obesity

Interventions

Vegetables

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Manfred Lamprecht, PhD

  Green Beat

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 21, 2021
• Study Start: September 1, 2021
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)