Thinking of joining a study?

Register your interest

NCT05870930 | Recruiting | Healthy Diet


Bioavailability and Satiety Study of a Cretan Carob Beverage
Sponsor:

Harokopio University

Information provided by (Responsible Party):

Andriana C Kaliora

Brief Summary:

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.

Condition or disease

Healthy Diet

Intervention/treatment

Carob beverage

Sucrose beverage

Phase

Not Applicable

Detailed Description:

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
Criteria
Inclusion Criteria
  • healthy males and females adults
  • normal weight
Exclusion Criteria
  • overweight/obesity (BMI>25kg/m2)
  • Type 1 Diabetes, cardiovascular diseases, hypertension
  • thyroid disorder, liver disease, kidney disease
  • gastrointestinal disease
  • pregnant or lactating women
  • mental illness
  • use of nutraceutical supplements or natural products for weight loss
  • dietitians/nutritionists

Bioavailability and Satiety Study of a Cretan Carob Beverage

Location Details


Please Choose a site



Bioavailability and Satiety Study of a Cretan Carob Beverage

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

Greece,

Andriana Kaliora

Athens, Greece, 17671

Loading...