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Bioavailability and Satiety Study of a Cretan Carob Beverage

Sponsor
Harokopio University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05870930
Collaborator
(none)
20
Enrollment
2
Arms
11
Anticipated Duration (Months)

Study Details

Study Description

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 Intervention/Treatment Phase
  • Other: Carob beverage
  • Other: Sucrose beverage
 N/A

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 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Bioavailability and Satiety Study of a Cretan Carob Beverage
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Carob beverage

Other: Carob beverage
Volunteers will consume 2 tablespoons of carob powder in 200mL drinking water.
Other: Sucrose beverage

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

Outcome Measures

Primary Outcome Measures

  1. Changes in VAS scale [Three hours]

    Changes in VAS scale for the comparison of subjective satiety between the two groups

Secondary Outcome Measures

  1. Differences in the weight of food remaining after consumption. [Three hours]

    Differences in the quantity of food remaining after consumption for the comparison of objective satiety between the two groups.

  2. Changes in plasma ghrelin [Three hours]

    Changes in plasma ghrelin for the comparison of objective satiety between the two groups.

  3. Identification of putative polyphenol metabolites related to carob consumption. [Three hours]

    Polyphenol metabolites related to carob consumption will be identified using LC-ESI-MS/MS.

  4. Investigation of the associations of the metabolic profile of the volunteers to the appetite modulation and satiety. [Three hours]

    Metabolic profile of the volunteers as assessed by LC-ESI-MS/MS will be evaluated for potential associations with appetite modulation and satiety.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Harokopio University

Investigators

  • Principal Investigator: Andriana C Kaliora, Harokopio University of Athens, Greece

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Andriana C Kaliora, Associate Professor, Harokopio University
ClinicalTrials.gov Identifier:
NCT05870930
Other Study ID Numbers:
  • CRETAN CAROB_147
First Posted:
May 23, 2023
Last Update Posted:
May 23, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 23, 2023