Bioavailability and Satiety Study of a Cretan Carob Beverage

Healthy Diet Clinical Trial

Official title:

Bioavailability and Satiety Study of a Cretan Carob Beverage

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05870930
• Other study ID #: CRETAN CAROB_147
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2024
• Est. completion date: October 1, 2025

Study information

• Verified date: March 2024
• Source: Harokopio University
• Contact: Andriana C Kaliora
• Phone: +302109549226
• Email: akaliora[@]hua.gr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Diet

Intervention

Other:
• Carob beverage
Volunteers will consume 2 tablespoons of carob powder in 200mL drinking water.
• Sucrose beverage
Volunteers will consume a beverage with sucrose equal to this contained in carob beverage (approx. 5g) prepared in 200mL drinking water.

Locations

Country	Name	City	State
Greece	Andriana Kaliora	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Harokopio University

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in visual analogue scale	Changes in visual analogue scale for the comparison of subjective satiety between the two groups. Values range 0-10, the higher the value the higher satiety	Three hours
Secondary	Weight/quantity of food remaining after consumption.	The weight/quantity of food remaining after consumption for the comparison of objective satiety between the two groups.	Three hours
Secondary	Plasma ghrelin levels	Plasma ghrelin levels in the two groups for the comparison of objective satiety between treatments.	Three hours
Secondary	Identification of putative polyphenol metabolites related to carob consumption.	Polyphenol metabolites related to carob consumption identified using LC-ESI-MS/MS.	Three hours
Secondary	Investigation of the associations of the metabolic profile of the volunteers to the appetite modulation and satiety.	Metabolic profile of the volunteers as assessed by LC-ESI-MS/MS will be evaluated for potential associations with appetite modulation and satiety.	Three hours