Acute Effect of Crocus Sativus on Postprandial Glycemia

Blood Pressure Clinical Trial

Official title:

Acute Effect of Two Doses of Crocus Sativus on Postprandial Glycemia: A Randomized Clinical Trial in Healthy Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05484362
• Other study ID #: HRBD 58/21.06.2022
• Status: Completed
• Phase: N/A
• Start date: June 6, 2022
• Est. completion date: July 26, 2022

Study information

• Verified date: July 2022
• Source: Agricultural University of Athens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: July 26, 2022
• Est. primary completion date: July 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Appetitive Behavior
• Blood Pressure
• Congenital Abnormalities
• Potential Abnormality of Glucose Tolerance

Intervention

Other:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Greece	Agricultural University of Athens	Athens	Attica

Sponsors (1)

Lead Sponsor	Collaborator
Agricultural University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Capillary blood glucose responses	Clinically useful change in blood glucose, defined as the restoration of glucose within normal limits during the 2-hour oral glucose tolerance test	2 hours
Secondary	Subjective appetite ratings	Useful change in subjective appetite using visual analogue scales with a score from 0 to 10 (given in the form of booklet, one scale per page) at baseline, 15, 30, 45, 60, 90 and 120 min. The minimum or maximum score will be evaluated if it is better or worse depending on the appetite variable e.g., hunger, satiety, desire to eat etc.	2 hours
Secondary	Blood pressure	Useful change in systolic and diastolic blood pressure before and 2-hour after consumption of the three beverages	2 hours