Acute Effect of Crocus Sativus on Postprandial Glycemia

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

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

Study Overview

• Status: Completed
• Conditions: Blood Pressure; Appetitive Behavior; Potential Abnormality of Glucose Tolerance
• Intervention / Treatment: Other: D-Glucose beverage as reference food; Other: 15mg of Crocus Sativus as beverage; Other: 30mg of Crocus Sativus as beverage

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Attica
    • Athens, Attica, Greece, 11855
      • Agricultural University of Athens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; 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.; 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.
Experimental: 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.	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.; 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.; 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.
Experimental: 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.	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.; 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Blood pressure	Useful change in systolic and diastolic blood pressure before and 2-hour after consumption of the three beverages	2 hours

Collaborators and Investigators

• Sponsor: Agricultural University of Athens

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2022
• Primary Completion (Actual): July 10, 2022
• Study Completion (Actual): July 26, 2022

Study Registration Dates

• First Submitted: July 30, 2022
• First Submitted That Met QC Criteria: July 30, 2022
• First Posted (Actual): August 2, 2022

Study Record Updates

• Last Update Posted (Actual): August 2, 2022
• Last Update Submitted That Met QC Criteria: July 30, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: blood pressure; subjective appetite; blood glucose concentrations; Crocus sativus; Blood glucose responses
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: HRBD 58/21.06.2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No