Overview

This trial is active, not recruiting.

Condition healthy
Treatment juice plus+(r)
Sponsor Green Beat
Collaborator Medical University of Graz
Start date October 2015
End date September 2016
Trial size 20 participants
Trial identifier NCT02587468, 27-507 ex 14/15

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification bio-availability study
Intervention model single group assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
Check of phenolic absorption between baseline and after 8wks of intake before-after comparison
juice plus+(r)
before-after comparison of plasma phenolics

Primary Outcomes

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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 20 years up to 50 years old.

Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Additional Information

Official title Bioavailability and Absorption Kinetics of Phenolic Compounds and Specific Vitamins of a Commercially Available, Encapsulated Nutraceutical (Juice Plus+®)
Principal investigator Manfred Lamprecht, PhD
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).
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Green Beat.