NCT05484362

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 6, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2022

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 2, 2022

Completed
Last Updated

August 2, 2022

Status Verified

July 1, 2022

Enrollment Period

1 month

First QC Date

July 30, 2022

Last Update Submit

July 30, 2022

Conditions

Potential Abnormality of Glucose ToleranceAppetitive BehaviorBlood Pressure

Keywords

Crocus sativusBlood glucose responsesblood pressuresubjective appetiteblood glucose concentrations

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Subjective appetite ratings

    2 hours

  • Blood pressure

    2 hours

Study Arms (3)

Glucose as reference food

EXPERIMENTAL

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 foodOther: 15mg of Crocus Sativus as beverageOther: 30mg of Crocus Sativus as beverage

15mg of Crocus Sativus as beverage

EXPERIMENTAL

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 foodOther: 15mg of Crocus Sativus as beverageOther: 30mg of Crocus Sativus as beverage

30mg of Crocus Sativus as beverage

EXPERIMENTAL

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 foodOther: 15mg of Crocus Sativus as beverageOther: 30mg of Crocus Sativus as beverage

Interventions

D-Glucose beverage as reference foodOTHER

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 beverage30mg of Crocus Sativus as beverageGlucose as reference food
15mg of Crocus Sativus as beverageOTHER

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 beverage30mg of Crocus Sativus as beverageGlucose as reference food
30mg of Crocus Sativus as beverageOTHER

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 beverage30mg of Crocus Sativus as beverageGlucose as reference food

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Agricultural University of Athens

Athens, Attica, 11855, Greece

Location

MeSH Terms

Conditions

Appetitive Behavior

Interventions

Beverages

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

Diet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Aimilia Papakonstantinou, PhD

    Agricultural University of Athens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
A researcher not involved in data analyses was responsible for participant allocation and test food consumption.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Crossover, double blind, randomized clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 30, 2022

First Posted

August 2, 2022

Study Start

June 6, 2022

Primary Completion

July 10, 2022

Study Completion

July 26, 2022

Last Updated

August 2, 2022

Record last verified: 2022-07

Locations

GR(1)