Bioavailability of Phenolic Compounds Following the Consumption of a Carob Beverage
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Harokopio University
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Identification of putative polyphenol metabolites related to carob consumption.
Study Overview
Brief Summary
This is an interventional, open-label, single-group, bioavailability postprandial study. The aim of the study is to evaluate the bioavailability of phenolic compounds of a beverage prepared with Cretan carob powder of the Imera cultivar in healthy individuals after consumption.
Detailed Description
This is an interventional, open-label, single-group, bioavailability postprandial study. The aim of the study is to evaluate the bioavailability of active constituents of a beverage with carob powder in healthy individuals after consumption. Fifteen apparently healthy male adults of normal body fat mass (non-obese) will be enrolled based on certain inclusion and exclusion criteria. After enrollment, the volunteers will undergo a medical and dietary assessment and will be instructed to follow a low-phytochemical diet (washout) for five consecutive days, excluding from their diet sources of phytochemicals, i.e., fruits, vegetables, legumes, coffee, tea. Compliance with the low-phytochemical diet will be assessed with a 24 h recall during and at the end of the washout period. On the day of the experiment following washout, volunteers will be given a carob beverage (blood samples will be collected 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 5.0, 6.0h postprandially). Time intervals 0-6h will be used for LC-ESI-MS/MS approach in order to identify putative polyphenol metabolites related to carob consumption.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •healthy male adults
- •normal body fat mass
Exclusion Criteria
- •obesity (according to body fat mass)
- •Type 1 Diabetes, cardiovascular diseases, hypertension
- •thyroid disorder, liver disease, kidney disease
- •gastrointestinal disease
- •mental illness
- •use of nutraceutical supplements or natural products for weight loss
- •dietitians/nutritionists
Arms & Interventions
Carob beverage
Intervention: Carob beverage (Other)
Outcomes
Primary Outcomes
Identification of putative polyphenol metabolites related to carob consumption.
Time Frame: Six hours
Polyphenol metabolites related to carob consumption identified using LC-ESI-MS/MS.
Secondary Outcomes
No secondary outcomes reported
Investigators
Andriana C. Kaliora
Associate Professor
Harokopio University
