Harokopio University
Andriana C Kaliora
This is an interventional, open-label, single-group, bioavailability and satiety postprandial crossover study. The aim of the study is to evaluate the bioavailability of active compounds of a beverage prepared with Cretan carob powder, as well as the subjective and objective satiety in healthy individuals after its consumption.
Healthy Diet
Carob beverage
Sucrose beverage
Not Applicable
This is an interventional, open-label, single-group, bioavailability and satiety postprandial crossover study. The aim of the study is to evaluate the bioavailability of active constituents of a beverage with carob powder and of the subjective and objective satiety of healthy individuals after its consumption. Twenty apparently healthy male and female adults of normal Body-Mass Index 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 and in a crossover design following washout, volunteers will be given either a sucrose beverage (blood samples will be collected 0.5, 1.0, 1.5, 2.0, 2.5 and 3.0 h postprandially) or a carob beverage (blood samples will be collected 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4-6 h postprandially). Time intervals 0-3h will be used for the measurement of ghrelin levels as a marker of objective satiety and time intervals 0-6h for LC-ESI-MS/MS approach in order (a) to identify putative polyphenol metabolites related to carob consumption and (b) to investigate the associations of the metabolic profile of the volunteers to the appetite modulation and satiety. Also, volunteers will self-assess appetite parameters using the visual analog scale (VAS) in time points 0-3h postprandially. Objective satiety will be measured through the next food intake; participants will consume a weighed snack that will be administered ad libitum 3h after the meal consumption. Food intake will be calculated by weighting the amount of snack food remaining after consumption.}}
Study Type : | Interventional |
Estimated Enrollment : | 20 participants |
Masking : | None (Open Label) |
Primary Purpose : | Prevention |
Official Title : | Bioavailability and Satiety Study of a Cretan Carob Beverage |
Actual Study Start Date : | February 10, 2024 |
Estimated Primary Completion Date : | October 1, 2025 |
Estimated Study Completion Date : | October 1, 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: Carob beverage |
Other: Carob beverage |
Other: Sucrose beverage |
Other: Sucrose beverage |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
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Recruiting
Andriana Kaliora
Athens, Greece, 17671