Cardiovascular and InflammAging Study

Cardiovascular Diseases Clinical Trial

Official title:

Effects of Long-term Consumption of Two Plant-based Dietary Supplements on Cardiovascular Health and Low-grade Inflammation in the Elderly

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04763291
• Other study ID #: 33-055 ex 20/21
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: Green Beat
• Contact: Manfred Lamprecht, PhD
• Phone: +43 664 1328287
• Email: manfred.lamprecht[@]greenbeat.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Cardiovascular Diseases
• Overweight
• Overweight or Obesity

Intervention

Dietary Supplement:
• Juice Plus+ Fruit, Vegetable and Berry blends
Encapsulated juice powder concentrate derived from 36 dried fruits, vegetables and berries.
• Juice Plus+ Omega blend
Encapsulated plant-based fatty acid supplement.

Locations

Country	Name	City	State
Austria	Green Beat	Graz
Austria	Otto Loewi Research Center, Section of Physiological Chemistry, Medical University of Graz	Graz

Sponsors (2)

Lead Sponsor	Collaborator
Green Beat	Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Plasma concentrations of vitamins and carotenoids	Retinol, vitamins C, D, E (a-toc and ?-toc), a-carotene, ß-carotene, lutein, zeaxanthin, lycopene, ß-cryptoxanthin	12 months
Other	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
Primary	Lipid profile markers	Total cholesterol, HDL, LDL, ApoA1, triglycerides, Omega-3-Index	12 months
Primary	Hemostasis markers	Platelet aggregation, thrombelastometry, coagulation (Quick, PT, PTT)	12 months
Primary	Oxidative stress markers	oxLDL, MDA, carbonyl proteins, (CP), redox state of albumin, homocysteine	12 months
Primary	Glucose metabolism	Glucose, insulin, HOMA-IR, HbA1c	12 months
Primary	Concentration changes in cytokines/ cytokine receptors	TNF-a, sTNFR1 and sTNFR2, CCL5 = RANTES, IL-1ß, hsCRP, CCL2 = MCP-1, Osteoprotegerin (OPG), IL-5, IL-8	12 months
Secondary	Vitamin K metabolism	Osteocalcin, matrix Gla protein (MGP), vitamins K1 and K2 (MK-7)	12 months
Secondary	mitochondrial DNA copy number (mtDNA-CN)	mitochondrial DNA will be amplified and the ratio to genomic DNA will be calculated	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Neurotrophins	BDNF and NGF will be measured by ELISA	12 months