NCT03348553

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 21, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2020

Completed
Last Updated

August 6, 2020

Status Verified

August 1, 2020

Enrollment Period

1.7 years

First QC Date

November 3, 2017

Last Update Submit

August 4, 2020

Conditions

Healthy

Keywords

Omega-fatty-acidsAbsorptionBioavailabilityFruit & Vegetable concentrateLipid Metabolism

Outcome Measures

Primary Outcomes (1)

  • Omega 3 index

    Omega 3 index in erythrocytes is a valid parameter to estimate bioavailability of omega 3 fatty acids

    4 months

Secondary Outcomes (1)

  • Change in lipid profile

    4 months

Other Outcomes (1)

  • Micronutrient Absorption

    4 months

Study Arms (4)

control group

SHAM COMPARATOR

20 subjects do not receive any supplementation

Dietary Supplement: control group

Omega2

ACTIVE COMPARATOR

20 subjects receive an Omega-Fatty-acid Nutratceutical

Dietary Supplement: Omega2

Omega4

ACTIVE COMPARATOR

20 subjects receive an Omega-Fatty-acid Nutraceutical

Dietary Supplement: Omega4

Omega2+OGV

ACTIVE COMPARATOR

20 subjects receive an Omega-Fatty-acid Nutraceutical + encapsulated fruit, vegetable and berry-juice concentrate

Dietary Supplement: Omega2+OGV

Interventions

control groupDIETARY_SUPPLEMENT

no supplements given for 16 weeks, after 4 week washout of all supplements and dietetic products

control group
Omega2DIETARY_SUPPLEMENT

2 capsules of JP+® Omega/d for 16 weeks, after 4 week washout of all supplements and dietetic products

Omega2
Omega4DIETARY_SUPPLEMENT

4 capsules of JP+® Omega/d for 16 weeks, after 4 week washout of all supplements and dietetic products

Omega4
Omega2+OGVDIETARY_SUPPLEMENT

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

Omega2+OGV

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institute of Pathophysiology and Immunology

Graz, Styria, 8010, Austria

Location

Green Beat

Graz, 8042, Austria

Location

MeSH Terms

Interventions

Control Groupsomega-(4-iodophenyl)pentadecanoic acid

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Manfred Lamprecht, PhD,PhD

    Green Beat and Medical University of Graz, Austria

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sponsor Investigator

Study Record Dates

First Submitted

November 3, 2017

First Posted

November 21, 2017

Study Start

September 1, 2017

Primary Completion

April 30, 2019

Study Completion

February 3, 2020

Last Updated

August 6, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

AU(2)