Acute Effect of Crocus Sativus on Postprandial Glycemia

Sponsor
Agricultural University of Athens (Other)
Overall Status
Completed
CT.gov ID
NCT05484362
Collaborator
(none)
11
1
3
1.6
6.7

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: D-Glucose beverage as reference food
  • Other: 15mg of Crocus Sativus as beverage
  • Other: 30mg of Crocus Sativus as beverage
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
11 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Crossover, double blind, randomized clinical trialCrossover, double blind, randomized clinical trial
Masking:
Double (Participant, Investigator)
Masking Description:
A researcher not involved in data analyses was responsible for participant allocation and test food consumption.
Primary Purpose:
Other
Official Title:
Acute Effect of Two Doses of Crocus Sativus on Postprandial Glycemia: A Randomized Clinical Trial in Healthy Humans
Actual Study Start Date :
Jun 6, 2022
Actual Primary Completion Date :
Jul 10, 2022
Actual Study Completion Date :
Jul 26, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Capillary blood glucose responses [2 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

  1. Subjective appetite ratings [2 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.

  2. Blood pressure [2 hours]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Agricultural University of Athens Athens Attica Greece 11855

Sponsors and Collaborators

  • Agricultural University of Athens

Investigators

  • Principal Investigator: Aimilia Papakonstantinou, PhD, Agricultural University of Athens

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aimilia Papakonstantinou, Assistant Professor, Agricultural University of Athens
ClinicalTrials.gov Identifier:
NCT05484362
Other Study ID Numbers:
  • HRBD 58/21.06.2022
First Posted:
Aug 2, 2022
Last Update Posted:
Aug 2, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Aimilia Papakonstantinou, Assistant Professor, Agricultural University of Athens
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 2, 2022