Cardiovascular and InflammAging Study

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Aging; Overweight or Obesity
• Intervention / Treatment: Dietary supplement: Juice Plus+ Fruit, Vegetable and Berry blends; Dietary supplement: Juice Plus+ Omega blend

• Study Type: Interventional
• Enrollment (Estimated): 112
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Manfred Lamprecht, PhD; Phone Number: +43 664 1328287; Email: manfred.lamprecht@greenbeat.at

Study Locations

• Austria
  • Graz, Austria, 8042
    • Recruiting
    • Green Beat
    • Contact: Manfred Lamprecht, Prof; Phone Number: +43 664 1328287; Email: manfred.lamprecht@greenbeat.at
  • Graz, Austria
    • Not yet recruiting
    • Otto Loewi Research Center, Section of Physiological Chemistry, Medical University of Graz
    • Contact: Gerhard Cvirn, PhD; Phone Number: +43 316 385 72122; Email: mailto:gerhard.cvirn@medunigraz.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma concentrations of vitamins and carotenoids	Retinol, vitamins C, D, E (α-toc and γ-toc), α-carotene, β-carotene, lutein, zeaxanthin, lycopene, β-cryptoxanthin	12 months
Plasma concentrations of fatty acids	Docosahexaenoic acid, docosapentaenoic acid, eicosapentaenoic acid, arachidonic acid, alphalinolenic acid, linoleic acid, oleic acid, palmitoleic acid, stearic acid.	12 months

Collaborators and Investigators

• Sponsor: Green Beat
• Collaborators: Medical University of Graz
• Investigators: Principal Investigator: Manfred Lamprecht, PhD, Green Beat

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: February 2, 2021
• First Submitted That Met QC Criteria: February 18, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Aging; CVD prevention; Low-grade inflammation
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Cardiovascular Diseases; Overweight
• Other Study ID Numbers: 33-055 ex 20/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No