Acute Effect of Crocus Sativus on Postprandial Glycemia

NCT ID: NCT05484362

Last Updated: 2022-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-06

Study Completion Date

2022-07-26

Brief Summary

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This study investigated the effects of two different doses of Crocus Sativus in glucose beverages on glycemic responses.

Detailed Description

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This study examined the short-term effects of two different doses (15 mg and 30 mg) of Crocus Sativus in glucose beverages on postprandial glycemic responses in healthy young adults.

Conditions

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Potential Abnormality of Glucose Tolerance Appetitive Behavior Blood Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Crossover, double blind, randomized clinical trial
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators
A researcher not involved in data analyses was responsible for participant allocation and test food consumption.

Study Groups

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Glucose as reference food

Eleven healthy subjects (male: 6, female: 5) after 10-14h fast, consumed 50 g D-glucose, three times, in different weeks along with 250 mL water; and 50 g D-glucose containing 15 mg and 30 mg of Crocus Sativus tested once, in different weeks along with 250 mL water. Fingertip capillary blood glucose samples were taken at 0, 15, 30, 45, 60, 90 and 120 min postmeal. The first glucose sample was taken exactly 15 min after the beginning of the consumption of the tested beverage.

Group Type EXPERIMENTAL

D-Glucose beverage as reference food

Intervention Type OTHER

Eleven healthy subjects (male: 6, female: 5) after 10-14h fast, consumed 50 g D-glucose, three times, in different weeks along with 250 mL water; and 50 g D-glucose containing 15 mg and 30 mg of Crocus Sativus tested once, in different weeks along with 250 mL water. Fingertip capillary blood glucose samples were taken at 0, 15, 30, 45, 60, 90 and 120 min postmeal. The first glucose sample was taken exactly 15 min after the beginning of the consumption of the tested beverage.

15mg of Crocus Sativus as beverage

Intervention Type OTHER

Eleven healthy subjects (male: 6, female: 5) after 10-14h fast, consumed 50 g D-glucose, three times, in different weeks along with 250 mL water; and 50 g D-glucose containing 15 mg and 30 mg of Crocus Sativus tested once, in different weeks along with 250 mL water. Fingertip capillary blood glucose samples were taken at 0, 15, 30, 45, 60, 90 and 120 min postmeal. The first glucose sample was taken exactly 15 min after the beginning of the consumption of the tested beverage.

30mg of Crocus Sativus as beverage

Intervention Type OTHER

Eleven healthy subjects (male: 6, female: 5) after 10-14h fast, consumed 50 g D-glucose, three times, in different weeks along with 250 mL water; and 50 g D-glucose containing 15 mg and 30 mg of Crocus Sativus tested once, in different weeks along with 250 mL water. Fingertip capillary blood glucose samples were taken at 0, 15, 30, 45, 60, 90 and 120 min postmeal. The first glucose sample was taken exactly 15 min after the beginning of the consumption of the tested beverage.

15mg of Crocus Sativus as beverage

Eleven healthy subjects (male: 6, female: 5) after 10-14h fast, consumed 50 g D-glucose, three times, in different weeks along with 250 mL water; and 50 g D-glucose containing 15 mg and 30 mg of Crocus Sativus tested once, in different weeks along with 250 mL water. Fingertip capillary blood glucose samples were taken at 0, 15, 30, 45, 60, 90 and 120 min postmeal. The first glucose sample was taken exactly 15 min after the beginning of the consumption of the tested beverage.

Group Type EXPERIMENTAL

D-Glucose beverage as reference food

Intervention Type OTHER

Eleven healthy subjects (male: 6, female: 5) after 10-14h fast, consumed 50 g D-glucose, three times, in different weeks along with 250 mL water; and 50 g D-glucose containing 15 mg and 30 mg of Crocus Sativus tested once, in different weeks along with 250 mL water. Fingertip capillary blood glucose samples were taken at 0, 15, 30, 45, 60, 90 and 120 min postmeal. The first glucose sample was taken exactly 15 min after the beginning of the consumption of the tested beverage.

15mg of Crocus Sativus as beverage

Intervention Type OTHER

Eleven healthy subjects (male: 6, female: 5) after 10-14h fast, consumed 50 g D-glucose, three times, in different weeks along with 250 mL water; and 50 g D-glucose containing 15 mg and 30 mg of Crocus Sativus tested once, in different weeks along with 250 mL water. Fingertip capillary blood glucose samples were taken at 0, 15, 30, 45, 60, 90 and 120 min postmeal. The first glucose sample was taken exactly 15 min after the beginning of the consumption of the tested beverage.

30mg of Crocus Sativus as beverage

Intervention Type OTHER

Eleven healthy subjects (male: 6, female: 5) after 10-14h fast, consumed 50 g D-glucose, three times, in different weeks along with 250 mL water; and 50 g D-glucose containing 15 mg and 30 mg of Crocus Sativus tested once, in different weeks along with 250 mL water. Fingertip capillary blood glucose samples were taken at 0, 15, 30, 45, 60, 90 and 120 min postmeal. The first glucose sample was taken exactly 15 min after the beginning of the consumption of the tested beverage.

30mg of Crocus Sativus as beverage

Eleven healthy subjects (male: 6, female: 5) after 10-14h fast, consumed 50 g D-glucose, three times, in different weeks along with 250 mL water; and 50 g D-glucose containing 15 mg and 30 mg of Crocus Sativus tested once, in different weeks along with 250 mL water. Fingertip capillary blood glucose samples were taken at 0, 15, 30, 45, 60, 90 and 120 min postmeal. The first glucose sample was taken exactly 15 min after the beginning of the consumption of the tested beverage.

Group Type EXPERIMENTAL

D-Glucose beverage as reference food

Intervention Type OTHER

Eleven healthy subjects (male: 6, female: 5) after 10-14h fast, consumed 50 g D-glucose, three times, in different weeks along with 250 mL water; and 50 g D-glucose containing 15 mg and 30 mg of Crocus Sativus tested once, in different weeks along with 250 mL water. Fingertip capillary blood glucose samples were taken at 0, 15, 30, 45, 60, 90 and 120 min postmeal. The first glucose sample was taken exactly 15 min after the beginning of the consumption of the tested beverage.

15mg of Crocus Sativus as beverage

Intervention Type OTHER

Eleven healthy subjects (male: 6, female: 5) after 10-14h fast, consumed 50 g D-glucose, three times, in different weeks along with 250 mL water; and 50 g D-glucose containing 15 mg and 30 mg of Crocus Sativus tested once, in different weeks along with 250 mL water. Fingertip capillary blood glucose samples were taken at 0, 15, 30, 45, 60, 90 and 120 min postmeal. The first glucose sample was taken exactly 15 min after the beginning of the consumption of the tested beverage.

30mg of Crocus Sativus as beverage

Intervention Type OTHER

Eleven healthy subjects (male: 6, female: 5) after 10-14h fast, consumed 50 g D-glucose, three times, in different weeks along with 250 mL water; and 50 g D-glucose containing 15 mg and 30 mg of Crocus Sativus tested once, in different weeks along with 250 mL water. Fingertip capillary blood glucose samples were taken at 0, 15, 30, 45, 60, 90 and 120 min postmeal. The first glucose sample was taken exactly 15 min after the beginning of the consumption of the tested beverage.

Interventions

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D-Glucose beverage as reference food

Eleven healthy subjects (male: 6, female: 5) after 10-14h fast, consumed 50 g D-glucose, three times, in different weeks along with 250 mL water; and 50 g D-glucose containing 15 mg and 30 mg of Crocus Sativus tested once, in different weeks along with 250 mL water. Fingertip capillary blood glucose samples were taken at 0, 15, 30, 45, 60, 90 and 120 min postmeal. The first glucose sample was taken exactly 15 min after the beginning of the consumption of the tested beverage.

Intervention Type OTHER

15mg of Crocus Sativus as beverage

Eleven healthy subjects (male: 6, female: 5) after 10-14h fast, consumed 50 g D-glucose, three times, in different weeks along with 250 mL water; and 50 g D-glucose containing 15 mg and 30 mg of Crocus Sativus tested once, in different weeks along with 250 mL water. Fingertip capillary blood glucose samples were taken at 0, 15, 30, 45, 60, 90 and 120 min postmeal. The first glucose sample was taken exactly 15 min after the beginning of the consumption of the tested beverage.

Intervention Type OTHER

30mg of Crocus Sativus as beverage

Eleven healthy subjects (male: 6, female: 5) after 10-14h fast, consumed 50 g D-glucose, three times, in different weeks along with 250 mL water; and 50 g D-glucose containing 15 mg and 30 mg of Crocus Sativus tested once, in different weeks along with 250 mL water. Fingertip capillary blood glucose samples were taken at 0, 15, 30, 45, 60, 90 and 120 min postmeal. The first glucose sample was taken exactly 15 min after the beginning of the consumption of the tested beverage.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy
* Non-smoking
* Non-diabetic men and women
* Body Mass Index (BMI) between 18.5 and 24.9 kg/m2
* Normal blood pressure

Exclusion Criteria

* Severe chronic disease (e.g., coronary heart disease, diabetes mellitus, kidney or liver conditions, endocrine conditions)
* Gastrointestinal disorders
* Pregnancy
* Lactation
* Competitive sports
* Alcohol abuse
* Drug dependency
* Allergy in Crocus Sativus
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Agricultural University of Athens

OTHER

Sponsor Role lead

Responsible Party

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Aimilia Papakonstantinou

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aimilia Papakonstantinou, PhD

Role: PRINCIPAL_INVESTIGATOR

Agricultural University of Athens

Locations

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Agricultural University of Athens

Athens, Attica, Greece

Site Status

Countries

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Greece

Other Identifiers

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HRBD 58/21.06.2022

Identifier Type: -

Identifier Source: org_study_id

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