Juice Plus+OMEGA Study
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ClinicalTrials.gov Identifier: NCT03348553 |
Recruitment Status :
Completed
First Posted : November 21, 2017
Last Update Posted : August 6, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Dietary Supplement: control group Dietary Supplement: Omega2 Dietary Supplement: Omega4 Dietary Supplement: Omega2+OGV | Not Applicable |

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
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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
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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
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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
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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 |
- Omega 3 index [ Time Frame: 4 months ]Omega 3 index in erythrocytes is a valid parameter to estimate bioavailability of omega 3 fatty acids
- Change in lipid profile [ Time Frame: 4 months ]Lipid metabolism may change over the time in a positive manner due to micronutrient intervention
- 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 |
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

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
Austria | |
Institute of Pathophysiology and Immunology | |
Graz, Styria, Austria, 8010 | |
Green Beat | |
Graz, Austria, 8042 |
Study Chair: | Manfred Lamprecht, PhD,PhD | Green Beat and Medical University of Graz, Austria |
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: | August 6, 2020 |
Last Verified: | August 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Omega-fatty-acids Absorption Bioavailability Fruit & Vegetable concentrate Lipid Metabolism |