Clinical trial NCT04763291: 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
Overall status: RECRUITING
Phase: NA
Conditions: Aging
Cardiovascular Diseases
Overweight or Obesity
Keywords: Aging
CVD prevention
Low-grade inflammation
Lead sponsor: Green Beat
Sponsor class: OTHER
Collaborators: name: Medical University of Graz
First posted: 2021-02-21
Enrollment: 80
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Lipid profile markers
timeFrame: 12 months
measure: Hemostasis markers
timeFrame: 12 months
measure: Oxidative stress markers
timeFrame: 12 months
measure: Glucose metabolism
timeFrame: 12 months
measure: Concentration changes in cytokines/ cytokine receptors
timeFrame: 12 months
Secondary outcomes:
measure: Vitamin K metabolism
timeFrame: 12 months
measure: mitochondrial DNA copy number (mtDNA-CN)
timeFrame: 12 months
measure: Upper respiratory tract symptoms
timeFrame: 12 months
measure: Quality of life Questionnaire
timeFrame: 12 months
measure: Cognitive function
timeFrame: 12 months
measure: Neurotrophins
timeFrame: 12 months
Other outcomes:
measure: Plasma concentrations of vitamins and carotenoids
timeFrame: 12 months
measure: Plasma concentrations of fatty acids
timeFrame: 12 months
Locations:
city: Graz
country: Austria
facility: Green Beat
city: Graz
country: Austria
facility: Otto Loewi Research Center, Section of Physiological Chemistry, Medical University of Graz
Study officials:
affiliation: Green Beat
name: Manfred Lamprecht, PhD
role: PRINCIPAL_INVESTIGATOR
References: