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Cardiovascular and InflammAging Study

Primary Purpose

Aging, Cardiovascular Diseases, Overweight or Obesity

Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Juice Plus+ Fruit, Vegetable and Berry blends
Juice Plus+ Omega blend
Sponsored by
Green Beat
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aging focused on measuring Aging, CVD prevention, Low-grade inflammation

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Post menopausal
  • Non-smokers
  • BMI 25 to 35 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Control group

Fruit, Vegetable and Berry (FVB) group

Omega group

Fruit, Vegetable, Berry and Omega (FVBO) group

Arm Description

Continue habitual diet and lifestyle.

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

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

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

Outcomes

Primary Outcome Measures

Lipid profile markers
Total cholesterol, HDL, LDL, ApoA1, triglycerides, Omega-3-Index
Hemostasis markers
Platelet aggregation, thrombelastometry, coagulation (Quick, PT, PTT)
Oxidative stress markers
oxLDL, MDA, carbonyl proteins, (CP), redox state of albumin, homocysteine
Glucose metabolism
Glucose, insulin, HOMA-IR, HbA1c
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

Secondary Outcome Measures

Vitamin K metabolism
Osteocalcin, matrix Gla protein (MGP), vitamins K1 and K2 (MK-7)
mitochondrial DNA copy number (mtDNA-CN)
mitochondrial DNA will be amplified and the ratio to genomic DNA will be calculated
Upper respiratory tract symptoms
The number of symptoms experienced and severity of symptoms will be assessed by the Wisconsin upper respiratory symptoms survey (WURSS).
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.
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).
Neurotrophins
BDNF and NGF will be measured by ELISA

Full Information

First Posted
February 2, 2021
Last Updated
September 12, 2023
Sponsor
Green Beat
Collaborators
Medical University of Graz
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1. Study Identification

Unique Protocol Identification Number
NCT04763291
Brief Title
Cardiovascular and InflammAging Study
Official Title
Effects of Long-term Consumption of Two Plant-based Dietary Supplements on Cardiovascular Health and Low-grade Inflammation in the Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Green Beat
Collaborators
Medical University of Graz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Cardiovascular Diseases, Overweight or Obesity
Keywords
Aging, CVD prevention, Low-grade inflammation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Continue habitual diet and lifestyle.
Arm Title
Fruit, Vegetable and Berry (FVB) group
Arm Type
Experimental
Arm Description
Participants have to ingest an encapsulated juice powder concentrate, otherwise continue their habitual diet and lifestyle.
Arm Title
Omega group
Arm Type
Experimental
Arm Description
Participants have to ingest a plant-based fatty acid supplement, otherwise continue their habitual diet and lifestyle.
Arm Title
Fruit, Vegetable, Berry and Omega (FVBO) group
Arm Type
Experimental
Arm Description
Participants have to ingest an encapsulated juice powder concentrate along with a plant-based fatty acid supplement, otherwise continue their habitual diet and lifestyle.
Intervention Type
Dietary Supplement
Intervention Name(s)
Juice Plus+ Fruit, Vegetable and Berry blends
Intervention Description
Encapsulated juice powder concentrate derived from 36 dried fruits, vegetables and berries.
Intervention Type
Dietary Supplement
Intervention Name(s)
Juice Plus+ Omega blend
Intervention Description
Encapsulated plant-based fatty acid supplement.
Primary Outcome Measure Information:
Title
Lipid profile markers
Description
Total cholesterol, HDL, LDL, ApoA1, triglycerides, Omega-3-Index
Time Frame
12 months
Title
Hemostasis markers
Description
Platelet aggregation, thrombelastometry, coagulation (Quick, PT, PTT)
Time Frame
12 months
Title
Oxidative stress markers
Description
oxLDL, MDA, carbonyl proteins, (CP), redox state of albumin, homocysteine
Time Frame
12 months
Title
Glucose metabolism
Description
Glucose, insulin, HOMA-IR, HbA1c
Time Frame
12 months
Title
Concentration changes in cytokines/ cytokine receptors
Description
TNF-α, sTNFR1 and sTNFR2, CCL5 = RANTES, IL-1β, hsCRP, CCL2 = MCP-1, Osteoprotegerin (OPG), IL-5, IL-8
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Vitamin K metabolism
Description
Osteocalcin, matrix Gla protein (MGP), vitamins K1 and K2 (MK-7)
Time Frame
12 months
Title
mitochondrial DNA copy number (mtDNA-CN)
Description
mitochondrial DNA will be amplified and the ratio to genomic DNA will be calculated
Time Frame
12 months
Title
Upper respiratory tract symptoms
Description
The number of symptoms experienced and severity of symptoms will be assessed by the Wisconsin upper respiratory symptoms survey (WURSS).
Time Frame
12 months
Title
Quality of life Questionnaire
Description
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.
Time Frame
12 months
Title
Cognitive function
Description
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).
Time Frame
12 months
Title
Neurotrophins
Description
BDNF and NGF will be measured by ELISA
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Plasma concentrations of vitamins and carotenoids
Description
Retinol, vitamins C, D, E (α-toc and γ-toc), α-carotene, β-carotene, lutein, zeaxanthin, lycopene, β-cryptoxanthin
Time Frame
12 months
Title
Plasma concentrations of fatty acids
Description
Docosahexaenoic acid, docosapentaenoic acid, eicosapentaenoic acid, arachidonic acid, alphalinolenic acid, linoleic acid, oleic acid, palmitoleic acid, stearic acid.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manfred Lamprecht, PhD
Phone
+43 664 1328287
Email
manfred.lamprecht@greenbeat.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manfred Lamprecht, PhD
Organizational Affiliation
Green Beat
Official's Role
Principal Investigator
Facility Information:
Facility Name
Green Beat
City
Graz
ZIP/Postal Code
8042
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manfred Lamprecht, Prof
Phone
+43 664 1328287
Email
manfred.lamprecht@greenbeat.at
Facility Name
Otto Loewi Research Center, Section of Physiological Chemistry, Medical University of Graz
City
Graz
Country
Austria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerhard Cvirn, PhD
Phone
+43 316 385 72122
Email
mailto:gerhard.cvirn@medunigraz.at

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Cardiovascular and InflammAging Study

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