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Juice Plus Inflammaging and Cardiovascular Disease Prevention Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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Recruitment Status : Terminated (One of the 2 nutritional products is reformulated and withdrawn from the market)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
Sponsor:
Collaborator:
Medical University of Graz
Information provided by (Responsible Party):
Lamprecht Manfred PhD, PhD, Green Beat

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.

Condition or disease Intervention/treatment
Overweight or Obesity Other: Juice Plus+ Complete Dietary Supplement: Juice Plus+ Premium

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Study Type : Observational
Actual Enrollment : 22 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Plant-based smoothie; maintaining habitual diet.

Active 2
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.




Primary Outcome Measures :
  1. Concentration changes in biomarkers of low-grade inflammation [ Time Frame: 24 months ]
    TNF-α, TNFsR2, TNFsR1, RANTES/ CCL5, IL-1β, osteoprotegerin (OPG)

  2. 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

  3. 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)


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


  4. Body mass assessment [ Time Frame: 24 months ]
    Dincl, Dexcl

  5. Anthropometrics [ Time Frame: 24 months ]
    waist circumference, mid arm muscle circumference, BMI, waist/hip ratio


Other Outcome Measures:
  1. 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

  2. Bone quality [ Time Frame: 24 months ]
    Stiffness index via ultrasound measures

  3. Telomere length [ Time Frame: 24 months ]
    PBMCs, T/S


Biospecimen Retention:   Samples Without DNA
Serum samples stored for future micronutrient analysis.


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Overweight and obese subjects with a higher probability of a low-grade inflammatory status compared to lean people.
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

Information from the National Library of Medicine

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


Locations
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Austria
Institute of Pathophysiology and Immunology
Graz, Styria, Austria, 8010
Green Beat
Graz, Austria, 8042
Sponsors and Collaborators
Green Beat
Medical University of Graz
Investigators
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Principal Investigator: Manfred Lamprecht, PhD Medical University of Graz
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Responsible Party: Lamprecht Manfred PhD, PhD, Principal Investigator, Green Beat
ClinicalTrials.gov Identifier: NCT04003935    
Other Study ID Numbers: 31-242 ex 18/19
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lamprecht Manfred PhD, PhD, Green Beat:
low-grade inflammation
aging
CVD prevention
Additional relevant MeSH terms:
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Overweight
Cardiovascular Diseases
Body Weight
Signs and Symptoms