Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2026-02-20 @ 10:10 PM
Study NCT ID:
NCT02587468
Status:
COMPLETED
Last Update Posted:
2017-08-01
First Post:
2015-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioavailability and Absorption Kinetics of Phenolic Compounds and Specific Vitamins
Sponsor:
Green Beat
Organization:
Study Overview
Official Title:
Bioavailability and Absorption Kinetics of Phenolic Compounds and Specific Vitamins of a Commercially Available, Encapsulated Nutraceutical (Juice Plus+®)
Status:
COMPLETED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 all inclusion criterions (see underneath).
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).
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: