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Bioavailability and Absorption Kinetics of Phenolic Compounds and Specific Vitamins

G

Green Beat

Status

Completed

Conditions

Healthy

Treatments

Dietary Supplement: Juice Plus+(R)

Study type

Interventional

Funder types

Other

Identifiers

NCT02587468
27-507 ex 14/15

Details and patient eligibility

About

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).

Full 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).

Enrollment

20 patients

Sex

All

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Juice Plus+(R)
Experimental group
Description:
Check of phenolic absorption between baseline and after 8wks of intake before-after comparison
Treatment:
Dietary Supplement: Juice Plus+(R)

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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