Juice Plus Inflammaging and Cardiovascular Disease Prevention Study
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|ClinicalTrials.gov Identifier: NCT04003935|
Recruitment Status : Terminated (One of the 2 nutritional products is reformulated and withdrawn from the market)
First Posted : July 1, 2019
Last Update Posted : May 29, 2020
|Condition or disease||Intervention/treatment|
|Overweight or Obesity||Other: Juice Plus+ Complete Dietary Supplement: Juice Plus+ Premium|
|Study Type :||Observational|
|Actual Enrollment :||22 participants|
|Official Title:||Effects of Long-term Consumption of Two Plant-based Dietary Supplements on Low-grade Inflammation, Cardiovascular Disease Prevention and Circulating Micronutrients in a Cohort of Elderly Volunteers|
|Actual Study Start Date :||June 1, 2019|
|Actual Primary Completion Date :||May 27, 2020|
|Actual Study Completion Date :||May 27, 2020|
Continuing habitual diet and lifestyle.
Ingestion of a macro- and micro-nutrient rich shake, otherwise continuing habitual diet and lifestyle.
Other: Juice Plus+ Complete
Plant-based smoothie; maintaining habitual diet.
Ingestion of an encapsulated vitamin and phytonutrient supplement, otherwise continuing habitual diet and lifestyle.
Dietary Supplement: Juice Plus+ Premium
Fruit and vegetable juice concentrate; maintaining habitual diet.
- Concentration changes in biomarkers of low-grade inflammation [ Time Frame: 24 months ]TNF-α, TNFsR2, TNFsR1, RANTES/ CCL5, IL-1β, osteoprotegerin (OPG)
- Plasma concentration changes in biomarkers of CVD [ Time Frame: 24 months ]Homocysteine, oxLDL, Chol, HDL, LDL, Triglycerides, Apo A1, HOMA-IR, Insulin, Glucose, HbA1c, osteocalcin
- Efficacy of micronutrients' absorption [ Time Frame: 24 months ]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)
- Wisconsin upper respiratory symptoms survey (WURSS) [ Time Frame: 24 months ]This is an exploratory questionnaire, consisting of 21 questions and collects information on respiratory tract symptoms.
- Gastrointestinal symptoms survey (GISS-14) [ Time Frame: 24 months ]This is a questionnaire consisting of 14 questions and is an exploratory assessment of overall gastrointestinal symptoms.
- Quality of life [ Time Frame: 24 months ]
Quality of life will be assessed through the Short Form Survey (SF-36). This is a questionnaire, consisting of 36 questions and 8 scales namely: 1) Physical functioning, 2) Role limitations due to physical health, 3) Role limitations due to emotional problems, 4) Energy/fatigue, 5) Emotional well-being, 6) Social functioning, 7) Pain and 8) General Health.
All questions are scored on a scale from 0 to 100, with higher scores representing a better health state.
- Body mass assessment [ Time Frame: 24 months ]Dincl, Dexcl
- Anthropometrics [ Time Frame: 24 months ]waist circumference, mid arm muscle circumference, BMI, waist/hip ratio
- Cognitive function test [ Time Frame: 24 months ]A total CFD-index can be calculated across all domains, taking into account the following dimensions: Expressive language, executive function, verbal long-term memory, attention, and perceptual motoric function
- Bone quality [ Time Frame: 24 months ]Stiffness index via ultrasound measures
- Telomere length [ Time Frame: 24 months ]PBMCs, T/S
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04003935
|Institute of Pathophysiology and Immunology|
|Graz, Styria, Austria, 8010|
|Graz, Austria, 8042|
|Principal Investigator:||Manfred Lamprecht, PhD||Medical University of Graz|