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Clinical Trials/NCT04763291
NCT04763291
Active, not recruiting
Not Applicable

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

Green Beat2 sites in 1 country112 target enrollmentSeptember 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aging
Sponsor
Green Beat
Enrollment
112
Locations
2
Primary Endpoint
Lipid profile markers
Status
Active, not recruiting
Last Updated
10 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2021
End Date
December 1, 2026
Last Updated
10 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Green Beat
Responsible Party
Principal Investigator
Principal Investigator

Lamprecht Manfred PhD, PhD

Principal Investigator

Green Beat

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

Outcomes

Primary Outcomes

Lipid profile markers

Time Frame: 12 months

Total cholesterol, HDL, LDL, ApoA1, triglycerides, Omega-3-Index

Concentration changes in cytokines/ cytokine receptors

Time Frame: 12 months

TNF-α, sTNFR1 and sTNFR2, CCL5 = RANTES, IL-1β, hsCRP, CCL2 = MCP-1, Osteoprotegerin (OPG), IL-5, IL-8

Oxidative stress markers

Time Frame: 12 months

oxLDL, MDA, carbonyl proteins, (CP), redox state of albumin, homocysteine

Glucose metabolism

Time Frame: 12 months

Glucose, insulin, HOMA-IR, HbA1c

Hemostasis markers

Time Frame: 12 months

Platelet aggregation, thrombelastometry, coagulation (Quick, PT, PTT)

Secondary Outcomes

  • Vitamin K metabolism(12 months)
  • mitochondrial DNA copy number (mtDNA-CN)(12 months)
  • Upper respiratory tract symptoms(12 months)
  • Quality of life Questionnaire(12 months)
  • Neurotrophins(12 months)
  • Cognitive function(12 months)

Study Sites (2)

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