HealthyNCT02587468
Bioavailability and Absorption Kinetics of Phenolic Compounds and Specific Vitamins
A study testing Juice Plus+(R) in people with Healthy, run by Green Beat at 2 sites in Austria.
Trial summary
GOAL To identify absorption kinetics and bioavailability of phenolic compounds and specific vitamins from encapsulated Juice Plus+® powder ENDPOINTS Absorption kinetics of phenolic compounds in plasma Bioavailability of vitamins C, E, and carotenoids into plasma Subjects: 20 healthy subjects from Graz region, meeting… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Juice Plus+(R)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesAustria
- Study dates
- Oct 2015to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20 healthy men and women, 20-50 years old;
- non-smokers;
- BMI >20 und <30 kg/m2;
- no medication;
- premenopausal;
- normal dietary habits (no specific diets, meals, food components etc.);
- adherence to wash-out period.
Who cannot join
- all people not meeting the inclusion criterions;
- diet: subjects consuming >4 servings of fruits and vegetables per day;
- subjects with any kind of food allergy or histamine intolerance;
- highly trained subjects (> 5 training units/week);
- women with menstrual dysfunctions;
- pregnancy
- alcoholics.
Trial locations and contacts
2 sites in 1 country.
Austria2 sites
Institute of Pathophysiology and Immunology
Graz, Styria, 8010
Green Beat
Graz, 8042
About this study
Official title: Bioavailability and Absorption Kinetics of Phenolic Compounds and Specific Vitamins of a Commercially Available, Encapsulated Nutraceutical (Juice Plus+®)
GOAL To identify absorption kinetics and bioavailability of phenolic compounds and specific vitamins from encapsulated Juice Plus+® powder
ENDPOINTS
- Absorption kinetics of phenolic compounds in plasma
- Bioavailability of vitamins C, E, and carotenoids into plasma
Subjects: 20 healthy subjects from Graz region, meeting all inclusion criterions (see underneath).
Read the detailed description
Phytonutrients are regarded to play an important role in many health-related issues like:
- Improvement of redox balance
- Anti-inflammatory effects
- Prevention of chronic diseases like CVD, stroke, diabetes II, Alzheimer´s, AMD, and certain forms of cancer
- Beneficial effects on human´s microbiome Therefore it is of scientific interest whether this product provides absorbable phytonutrients/phenolics and vitamins to support mechanistic explanations for the beneficial outcomes observed in the past after intake of Juice Plus+®.
GOAL To identify absorption kinetics and bioavailability of phenolic compounds and specific vitamins from encapsulated Juice Plus+® powder
MERITS
- This study would reveal knowledge whether and to which extent specific vitamins and phenolic compounds are absorbed, including absorption kinetics/metabolism.
- Data of this study may provide support for mechanistic arguments on the beneficial clinical outcomes observed and published in the past.
ENDPOINTS
- Absorption kinetics of phenolic compounds in plasma
- Bioavailability of vitamins C, E, and carotenoids into plasma
Absorption kinetics of phytonutrients:
- Open-, one-arm study, absorption kinetics over 10 hours
- 5 blood sample collections: baseline (= 0); 1hr, 2hrs, 5hrs and 10 hours after intake of 3 capsules
- Wash-out of all food supplements and dietetic foodstuff: 2 weeks
- Wash-out of phytonutrients: 48 hours before baseline sampling, accomplished via a phytonutrient-poor diet.
Bioavailability of vitamins C, E, A and carotenoids:
- Open-, one-arm study over 8 weeks
- 2 blood sample collections: at baseline (2 weeks after the phenolics experiment) and after 8-weeks
- Wash-out of all food supplements and dietetic foodstuff: 4 weeks, 2 weeks before the phenolics experiment + another 2 weeks Subjects: 20 healthy subjects from Graz region, meeting all inclusion criterions (see underneath).
- Conditions
- Healthy
- Being tested
- Juice Plus+(R)
- Keywords
- phenolics, absorption, fruit & vegetable concentrate, Bioavailability of phenolic compounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Juice Plus+(R)Dietary supplement
before-after comparison of plasma phenolics
| Study group | Role | What they receive |
|---|---|---|
| Juice Plus+(R) | Experimental | Check of phenolic absorption between baseline and after 8wks of intake before-after comparison Receives: Dietary Supplement: Juice Plus+(R) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absorption kinetics of phenolic acids after 1, 2, 5 and 10 hours, measured via HPLC, evaluated by repeated measures ANOVA, and assessed via SPSS 19.0.
For the phenolics analyses subjects come to the lab after an overnight fast, and after 2 weeks wash-out of all food supplements and 48 hours wash-out of phytonutrients (phytonutrient-poor diet). To adhere to the phytonutrient-poor diet they receive an exact diet plan in the forefront. This plan will be perused with the research associate. After the baseline blood drawing, they receive 3 capsules of Juice Plus+® consumed with 250ml plain water from the pipe. They will be instructed to swallow one capsule of each blend (fruit, berry, vegetable). During this day 4 additional blood samples will be drawn: 1hr, 2hrs, 5hrs, 10hrs after capsule intake in the morning.
After the 2hrs blood sampling the subjects get a standardized, phytonutrient-poor snack: white bread, cheese, ham, milk and water ad libitum. Subjects will receive a list with suggestions of allowed food they could consume on this day.
Measured: 1 year
Secondary outcomes (1)
Absorption of ß-carotene after 8 weeks of supplementation, measured via HPLC, evaluated by paired t-test, and assessed via SPSS 19.0
Two weeks after the first blood drawings, for the phytonutrient absorption and absorption kinetics, subjects will be invited to another visit to the laboratory. During these two weeks the volunteers adhere to the wash-out from all food supplements. After an overnight fast they come to the lab for the baseline blood drawings to evaluate vitamins and carotenoids absorption. This procedure will be repeated after 8 weeks of supplementation with 6 capsules of Juice Plus+® per day (~2.2g juice powder per day). During this time subjects will be instructed to maintain their habitual diet.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionJun 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Green Beat
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Graz
- Responsible party
- Principal investigator, Lamprecht Manfred PhD, PhD, Green Beat
- Investigators
- Manfred Lamprecht, PhD, Principal investigator, Green Beat + Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02587468
- Sponsor's protocol ID
- 27-507 ex 14/15
- Status last verified
- Jul 2017
- First submitted
- 22 Oct 2015
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability and Absorption Kinetics of Phenolic Compounds and Specific Vitamins of a Commercially Available, Encapsulated Nutraceutical (Juice Plus+®)
- ClinicalTrials.gov ID
- NCT02587468
- Acronym / sponsor ID
- 27-507 ex 14/15
- Conditions
- Healthy
- Keywords
- phenolics, absorption, fruit & vegetable concentrate, Bioavailability of phenolic compounds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Green BeatUniversity, hospital or other
- Collaborators
- Medical University of Graz
- Study start
- Oct 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 27 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
GOAL To identify absorption kinetics and bioavailability of phenolic compounds and specific vitamins from encapsulated Juice Plus+® powder
ENDPOINTS
- Absorption kinetics of phenolic compounds in plasma
- Bioavailability of vitamins C, E, and carotenoids into plasma
Subjects: 20 healthy subjects from Graz region, meeting all inclusion criterions (see underneath).
Detailed description
Phytonutrients are regarded to play an important role in many health-related issues like:
- Improvement of redox balance
- Anti-inflammatory effects
- Prevention of chronic diseases like CVD, stroke, diabetes II, Alzheimer´s, AMD, and certain forms of cancer
- Beneficial effects on human´s microbiome Therefore it is of scientific interest whether this product provides absorbable phytonutrients/phenolics and vitamins to support mechanistic explanations for the beneficial outcomes observed in the past after intake of Juice Plus+®.
GOAL To identify absorption kinetics and bioavailability of phenolic compounds and specific vitamins from encapsulated Juice Plus+® powder
MERITS
- This study would reveal knowledge whether and to which extent specific vitamins and phenolic compounds are absorbed, including absorption kinetics/metabolism.
- Data of this study may provide support for mechanistic arguments on the beneficial clinical outcomes observed and published in the past.
ENDPOINTS
- Absorption kinetics of phenolic compounds in plasma
- Bioavailability of vitamins C, E, and carotenoids into plasma
Absorption kinetics of phytonutrients:
- Open-, one-arm study, absorption kinetics over 10 hours
- 5 blood sample collections: baseline (= 0); 1hr, 2hrs, 5hrs and 10 hours after intake of 3 capsules
- Wash-out of all food supplements and dietetic foodstuff: 2 weeks
- Wash-out of phytonutrients: 48 hours before baseline sampling, accomplished via a phytonutrient-poor diet.
Bioavailability of vitamins C, E, A and carotenoids:
- Open-, one-arm study over 8 weeks
- 2 blood sample collections: at baseline (2 weeks after the phenolics experiment) and after 8-weeks
- Wash-out of all food supplements and dietetic foodstuff: 4 weeks, 2 weeks before the phenolics experiment + another 2 weeks Subjects: 20 healthy subjects from Graz region, meeting all inclusion criterions (see underneath).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Juice Plus+(R) | Experimental | Dietary Supplement: Juice Plus+(R)Check of phenolic absorption between baseline and after 8wks of intake before-after comparison |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 20 healthy men and women, 20-50 years old;
- non-smokers;
- BMI >20 und <30 kg/m2;
- no medication;
- premenopausal;
Key exclusion criteria (7 listed)
- all people not meeting the inclusion criterions;
- diet: subjects consuming >4 servings of fruits and vegetables per day;
- subjects with any kind of food allergy or histamine intolerance;
- highly trained subjects (> 5 training units/week);
- women with menstrual dysfunctions;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Juice Plus+(R)before-after comparison of plasma phenolics | Dietary supplement | Juice Plus+(R) |
Primary outcome
Absorption kinetics of phenolic acids after 1, 2, 5 and 10 hours, measured via HPLC, evaluated by repeated measures ANOVA, and assessed via SPSS 19.0.
Time frame: 1 year
For the phenolics analyses subjects come to the lab after an overnight fast, and after 2 weeks wash-out of all food supplements and 48 hours wash-out of phytonutrients (phytonutrient-poor diet). To adhere to the phytonutrient-poor diet they receive an exact diet plan in the forefront. This plan will be perused with the research associate. After the baseline blood drawing, they receive 3 capsules of Juice Plus+® consumed with 250ml plain water from the pipe. They will be instructed to swallow one capsule of each blend (fruit, berry, vegetable). During this day 4 additional blood samples will be drawn: 1hr, 2hrs, 5hrs, 10hrs after capsule intake in the morning. After the 2hrs blood sampling the subjects get a standardized, phytonutrient-poor snack: white bread, cheese, ham, milk and water ad libitum. Subjects will receive a list with suggestions of allowed food they could consume on this day.
1 secondary outcome
Absorption of ß-carotene after 8 weeks of supplementation, measured via HPLC, evaluated by paired t-test, and assessed via SPSS 19.0
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manfred Lamprecht, PhD principal investigator
Green Beat + Medical University of Graz
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Juice Plus+(R) in people with Healthy, run by Green Beat at 2 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absorption kinetics of phenolic acids after 1, 2, 5 and 10 hours, measured via HPLC, evaluated by repeated measures ANOVA, and assessed via SPSS 19.0. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2017.