Bioavailability and Absorption Kinetics of Phenolic Compounds and Specific Vitamins
1 other identifier
interventional
20
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Oct 2015
Typical duration for not_applicable healthy
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 22, 2015
CompletedFirst Posted
Study publicly available on registry
October 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedAugust 1, 2017
July 1, 2017
1.7 years
October 22, 2015
July 29, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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
1 year
Study Arms (1)
Juice Plus+(R)
EXPERIMENTALCheck of phenolic absorption between baseline and after 8wks of intake before-after comparison
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Green Beatlead
- Medical University of Grazcollaborator
Study Sites (2)
Institute of Pathophysiology and Immunology
Graz, Styria, 8010, Austria
Green Beat
Graz, 8042, Austria
Study Officials
- PRINCIPAL INVESTIGATOR
Manfred Lamprecht, PhD
Green Beat + Medical University of Graz
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 22, 2015
First Posted
October 27, 2015
Study Start
October 1, 2015
Primary Completion
June 1, 2017
Study Completion
July 1, 2017
Last Updated
August 1, 2017
Record last verified: 2017-07