Cardiovascular and InflammAging Study

Green Beat

Status: Active, not recruiting

Conditions: Aging; Overweight or Obesity; Cardiovascular Diseases

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04763291

33-055 ex 20/21

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 55 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

Control group

No Intervention group

Description:

Continue habitual diet and lifestyle.

Fruit, Vegetable and Berry (FVB) group

Experimental group

Description:

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

Treatment:

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

Omega group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Juice Plus+ Omega blend

Fruit, Vegetable, Berry and Omega (FVBO) group

Experimental group

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.

Treatment:

Dietary Supplement: Juice Plus+ Omega blend

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