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Search / Trial NCT04003935

Juice Plus Inflammaging and Cardiovascular Disease Prevention Study

Launched by GREEN BEAT · Jun 28, 2019

Trial Information

Current as of June 10, 2025

Terminated

Keywords

Low Grade Inflammation Aging Cvd Prevention

ClinConnect Summary

Inflammation is a central component of innate (non-specific) immunity. The termination of inflammation is an active process involving cytokines and anti-inflammatory mediators like lipids and micronutrients. Inflammation acts as both, 'friend and foe'; it is an essential component of immunosurveillance and host defense, but a chronic low-grade inflammatory state is a pathological feature of a wide range of chronic conditions, such as the metabolic syndrome or cardiovascular diseases (CVD). In addition, low-grade inflammation and oxidative stress are often associated with increased body fat ...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 90 male and female subjects
  • age: 50 - 80 years
  • post- or peri-menopausal
  • Smokers and non-smokers
  • BMI 25 to 40 kg/m2
  • Dietary Inflammatory Index, DII: 0 to +10
  • Fruit and vegetable intake \<4 servings/d
  • Adherence to a 6-week "wash-out" period
  • Since the intervals between blood drawings are long (6 months), a temporary intake (e.g for a few days, one or two weeks) of some excluded drugs and food supplements does not necessarily mean exclusion from the study
  • Exclusion Criteria:
  • Age \<50 and \>79.9 years
  • Dietary Inflammatory Index, DII: - 0.1 to -10
  • Subjects with any kind of food allergy or histamine intolerance
  • Aversion to stop the intake of nutritional supplements and food, that could interfere with the study outcome
  • Food supplements, functional foods and dietetic products with anti-inflammatory or redox-biological relevance like omega-3 fatty acids, plant/herbal extracts/concentrates, vitamin- and mineral supplements
  • Fruit and vegetable intake \>3 servings per day
  • Hypertension, starting with grade 2 according to the classification of the European Society of Hypertension: systolic blood pressure \> 160 mmHg, diastolic blood pressure \>100 mmHg
  • Medication: any anti-inflammatory medication and medication with relevant antioxidant properties, blood pressure lowering medication, psychotropic drugs, immunosuppressives, cytostatics, anticoagulants, contraceptives, diuretics, pain medication
  • Clinically relevant infectious disease
  • Diabetes mellitus type I and type II
  • Auto-immuno diseases
  • Any stents and Coronary artery diseases (CAD)
  • Cancer patients
  • Pregnancy

About Green Beat

Green Beat is an innovative clinical trial sponsor committed to advancing healthcare through groundbreaking research and development. With a focus on sustainable and environmentally conscious practices, Green Beat specializes in facilitating clinical trials that prioritize patient safety and efficacy while minimizing ecological impact. The organization collaborates with a diverse range of stakeholders, including pharmaceutical companies, research institutions, and healthcare providers, to drive forward the development of novel therapies and treatment modalities. By leveraging cutting-edge technology and a patient-centered approach, Green Beat aims to contribute to the advancement of medical science and improve health outcomes globally.

Locations

Graz, , Austria

Graz, Styria, Austria

Patients applied

0 patients applied

Trial Officials

Manfred Lamprecht, PhD

Principal Investigator

Medical University of Graz

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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