Juice Plus Inflammaging and Cardiovascular Disease Prevention Study

NCT04003935 | Terminated DMC

• 1 other identifier: 31-242 ex 18/19
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 2

Brief Summary

Low- grade inflammation is a pathological feature of a wide range of chronic conditions, including the metabolic syndrome, cardiovascular diseases (CVD) and the accelerated reduction in bone density. Previous research shows that diets rich in fruits and vegetables can reduce chronic inflammation. To date there is no data on multiyear clinical interventions assessing the effect of plant-based dietary supplements on low-grade inflammation, cardiovascular disease prevention and indicators of biological aging, including individuals' cognitive function. In this study, the investigators are thus exploring whether separate ingestions of two plant-based nutritional products over 2 years, are able to modulate low-grade inflammation, parameters of CVD prevention, circulating micronutrients, upper respiratory tract- and gastro-intestinal symptoms, quality of life, indicators of biological aging, and cognitive function in overweight seniors.

Conditions

Overweight or Obesity

Keywords

low-grade inflammation; aging; CVD prevention

Outcome Measures

Primary Outcomes (3)

• Concentration changes in biomarkers of low-grade inflammation

  TNF-α, TNFsR2, TNFsR1, RANTES/ CCL5, IL-1β, osteoprotegerin (OPG)

  24 months

• Plasma concentration changes in biomarkers of CVD

  Homocysteine, oxLDL, Chol, HDL, LDL, Triglycerides, Apo A1, HOMA-IR, Insulin, Glucose, HbA1c, osteocalcin

  24 months

• Efficacy of micronutrients' absorption

  Vitamin C, α-carotene, lycopene, ß-cryptoxanthin, α-tocopherol, vitamin A (retinol), ß-carotene, lutein/zeaxanthin, γ-tocopherol, vitamin D, vitamin K1, vitamin K2 (MK-7), matrix gla protein (MGP)

  24 months

Secondary Outcomes (5)

• Wisconsin upper respiratory symptoms survey (WURSS)

  24 months

• Gastrointestinal symptoms survey (GISS-14)

  24 months

• Quality of life

  24 months

• Body mass assessment

  24 months

• Anthropometrics

  24 months

Other Outcomes (3)

• Cognitive function test

  24 months

• Bone quality

  24 months

• Telomere length

  24 months

Study Arms (3)

Control

Continuing habitual diet and lifestyle.

Active 1

Ingestion of a macro- and micro-nutrient rich shake, otherwise continuing habitual diet and lifestyle.

Other: Juice Plus+ Complete

Active 2

Ingestion of an encapsulated vitamin and phytonutrient supplement, otherwise continuing habitual diet and lifestyle.

Dietary Supplement: Juice Plus+ Premium

Interventions

Juice Plus+ Complete OTHER

Plant-based smoothie; maintaining habitual diet.

Active 1

Juice Plus+ Premium DIETARY_SUPPLEMENT

Fruit and vegetable juice concentrate; maintaining habitual diet.

Active 2

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Overweight and obese subjects with a higher probability of a low-grade inflammatory status compared to lean people.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Green Beat: lead
• Medical University of Graz: collaborator

Study Sites (2)

Institute of Pathophysiology and Immunology

Graz, Styria, 8010, Austria

Location

Green Beat

Graz, 8042, Austria

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples stored for future micronutrient analysis.

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Manfred Lamprecht, PhD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: July 1, 2019
• Study Start: June 1, 2019
• Primary Completion: May 27, 2020
• Study Completion: May 27, 2020
• Last Updated: May 29, 2020

Record last verified: 2020-05

Locations

AU (2)