Bioavailability and Satiety Study of a Cretan Carob Beverage

Study Overview
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Brief Summary
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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.

Detailed Description
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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 or a carob beverage before consuming a standard meal. Blood samples will be collected 0.5, 1.0, 1.5, 2.0, 2.5 and 3.0 h postprandially and isolated serum and plasma samples in all time intervals will be used for the measurement of ghrelin levels as a marker of objective satiety and 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 all time points postprandially. Additionally, 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.

Official Title
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Bioavailability and Satiety Study of a Cretan Carob Beverage

Conditions
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Healthy Diet

Intervention / Treatment
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* Other: Carob beverage
* Other: Sucrose beverage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carob beverage<br> | Other: Carob beverage<br>* Volunteers will consume 2 tablespoons of carob powder in 200mL drinking water.<br>|
| Other: Sucrose beverage<br> | Other: Sucrose beverage<br>* Volunteers will consume a beverage with sucrose equal to this contained in carob beverage (approx. 5g) prepared in 200mL drinking water.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Plasma ghrelin levels | Plasma ghrelin levels in the two groups for the comparison of objective satiety between treatments. | Three hours | 
| Identification of putative polyphenol metabolites related to carob consumption. | Polyphenol metabolites related to carob consumption identified using LC-ESI-MS/MS. | Three hours | 
| 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 |