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Acute Effect of Crocus Sativus on Postprandial Glycemia

Not Applicable
Completed
Conditions
Potential Abnormality of Glucose Tolerance
Blood Pressure
Appetitive Behavior
Interventions
Other: D-Glucose beverage as reference food
Other: 15mg of Crocus Sativus as beverage
Other: 30mg of Crocus Sativus as beverage
Registration Number
NCT05484362
Lead Sponsor
Agricultural University of Athens
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
11
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 & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Glucose as reference food30mg of Crocus Sativus as beverageEleven 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 beverage15mg of Crocus Sativus as beverageEleven 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.
Glucose as reference foodD-Glucose beverage as reference foodEleven 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 beverageD-Glucose beverage as reference foodEleven 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.
Glucose as reference food15mg of Crocus Sativus as beverageEleven 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 beverage30mg of Crocus Sativus as beverageEleven 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 beverage15mg of Crocus Sativus as beverageEleven 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 beverageD-Glucose beverage as reference foodEleven 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 beverage30mg of Crocus Sativus as beverageEleven 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.
Primary Outcome Measures
NameTimeMethod
Capillary blood glucose responses2 hours

Clinically useful change in blood glucose, defined as the restoration of glucose within normal limits during the 2-hour oral glucose tolerance test

Secondary Outcome Measures
NameTimeMethod
Subjective appetite ratings2 hours

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.

Blood pressure2 hours

Useful change in systolic and diastolic blood pressure before and 2-hour after consumption of the three beverages

Trial Locations

Locations (1)

Agricultural University of Athens

🇬🇷

Athens, Attica, Greece

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