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Juice Plus+OMEGA 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: NCT03348553
Recruitment Status : Completed
First Posted : November 21, 2017
Last Update Posted : March 19, 2020
Sponsor:
Collaborator:
Medical University of Graz
Information provided by (Responsible Party):
Lamprecht Manfred PhD, PhD, Green Beat

Brief Summary:
In this randomized, controlled clinical study firstly the bioavailability of fatty acids and micronutrients of JP+® Omega Blend will be analysed. Secondly, the effect of the constituents contained in the nutraceuticals on blood lipid values will be determined. Thirdly, it will be examined, whether a dose-dependent effect of the supplementation of JP+® Omega Blend exists. Fourthly, the effect of a combined consumption of JP+® Omega Blend and Juice Plus+® Orchard, Garden and Vineyard blend (JP+® OGV) is investigated.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: control group Dietary Supplement: Omega2 Dietary Supplement: Omega4 Dietary Supplement: Omega2+OGV Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: subjects are randomised into one of 4 intervention groups (control group (CG; consumption of 2 capsules of JP+® Omega Blend/d (Ω2); consumption of 4 capsules JP+® Omega Blend/d (Ω4); consumption of 2 capsules JP+® Omega Blend + Juice Plus+® fruit, vegetable and berry juice concentrate with 2 capsules each /d (Ω2+OGV)). Subjects allocated to Ω2 and Ω4 will receive the herbal fatty acid nutraceutical in the 4-month long study period (intervention phase), subjects allocated to Ω2+OGV will additionally receive the fruit, vegetable and berry juice concentrate. The control group will refrain from using any supplements over the course of this period and will maintain their usual eating habits.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Bioavailability of Major Compounds of a Vegan Fatty-acid Nutraceutical and Its Effect on the Lipid Profile in Individuals With Suboptimal Serum-lipid Values
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : April 30, 2019
Actual Study Completion Date : February 3, 2020

Arm Intervention/treatment
Sham Comparator: control group
20 subjects do not receive any supplementation
Dietary Supplement: control group
no supplements given for 16 weeks, after 4 week washout of all supplements and dietetic products

Active Comparator: Omega2
20 subjects receive an Omega-Fatty-acid Nutratceutical
Dietary Supplement: Omega2
2 capsules of JP+® Omega/d for 16 weeks, after 4 week washout of all supplements and dietetic products

Active Comparator: Omega4
20 subjects receive an Omega-Fatty-acid Nutraceutical
Dietary Supplement: Omega4
4 capsules of JP+® Omega/d for 16 weeks, after 4 week washout of all supplements and dietetic products

Active Comparator: Omega2+OGV
20 subjects receive an Omega-Fatty-acid Nutraceutical + encapsulated fruit, vegetable and berry-juice concentrate
Dietary Supplement: Omega2+OGV
2 capsules of JP+® Omega/d plus 2 capsules each of an encapsulated fruit, vegetable and berry-juice concentrate (6 capsules) for 16 weeks, after 4 week washout of all supplements and dietetic products




Primary Outcome Measures :
  1. Omega 3 index [ Time Frame: 4 months ]
    Omega 3 index in erythrocytes is a valid parameter to estimate bioavailability of omega 3 fatty acids


Secondary Outcome Measures :
  1. Change in lipid profile [ Time Frame: 4 months ]
    Lipid metabolism may change over the time in a positive manner due to micronutrient intervention


Other Outcome Measures:
  1. Micronutrient Absorption [ Time Frame: 4 months ]
    Absorption of ß-carotene, tocopherols, vitamin A and vitamin C after 8 and 16 weeks of supplementation, measured via HPLC, proven by a UV detector, analysed by means of an internal standard method, evaluated by paired t-test, and assessed via SPSS 22.0



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 80 healthy men and women, 20-65 years
  • suboptimal serum lipid values without medication
  • triglycerides >140 mg/dl
  • HDL Chol < 45 (m) or < 50 mg/dl (w)
  • Non smokers
  • BMI >20 and <35 kg/m2
  • ω-3-fatty acid index (ω-3 index): rank 21 - 100 of the ranking or ω-3 index < 8%
  • normal nutrition (omnivore diet)
  • adherence to the 4-week long wash-out period

Exclusion criteria:

  • all people not meeting the inclusion criterions
  • hypertension (systolic blood pressure > 160mmHg, diastolic blood pressure >100 mmHg)
  • Specific diets and nutritional habits (vegan, vegetarian, paleo, low-carb pregnancy)
  • aversion to stop the intake of nutritional supplements and food, that could interfere with the study outcome
  • over-consumption of fish (> 1 portion/week)
  • linseed and walnut oil, whole linseeds and walnuts (>1 portion (25g)/day)
  • with omega-3 fatty acids enriched "functional food
  • intake of lipid-lowering, anti-inflammatory, blood pressure lowering medication and anticoagulants
  • clinically relevant infectious disease
  • acute and chronic inflammatory disease
  • Diabetes mellitus type I and type II
  • supplementation of antioxidants in all variations, omega-3 fatty acids, plant extracts/concentrates

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): NCT03348553


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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Study Chair: Manfred Lamprecht, PhD,PhD Green Beat and Medical University of Graz, Austria

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Responsible Party: Lamprecht Manfred PhD, PhD, Sponsor Investigator, Green Beat
ClinicalTrials.gov Identifier: NCT03348553    
Other Study ID Numbers: 29-525ex16/17
First Posted: November 21, 2017    Key Record Dates
Last Update Posted: March 19, 2020
Last Verified: March 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:
Omega-fatty-acids
Absorption
Bioavailability
Fruit & Vegetable concentrate
Lipid Metabolism