Potential Abnormality of Glucose ToleranceNCT05484362

Acute Effect of Crocus Sativus on Postprandial Glycemia

A study testing D-Glucose beverage as reference food, 15mg of Crocus Sativus as beverage and 30mg of Crocus Sativus as beverage in people with Potential Abnormality of Glucose Tolerance and Appetitive Behavior, run by Agricultural University of Athens at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Potential Abnormality of Glucose Tolerance, Appetitive Behavior, Blood Pressure
What is being tested?: D-Glucose beverage as reference food, 15mg of Crocus Sativus as beverage and 30mg of Crocus Sativus as beverage
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 1 siteGreece
Study dates: 6 Jun 2022to 26 Jul 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Greece1 site

Agricultural University of Athens
Athens, Attica, 11855

Other trials in Greece

About this study

Official title: 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.

Read the 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.

Conditions: Potential Abnormality of Glucose Tolerance, Appetitive Behavior, Blood Pressure
Being tested: D-Glucose beverage as reference food, 15mg of Crocus Sativus as beverage, 30mg of Crocus Sativus as beverage
Keywords: Crocus sativus, Blood glucose responses, blood pressure, subjective appetite, blood glucose concentrations
Medical subject headings: Appetitive Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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 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.
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.

Study groups in NCT05484362
Study group	Role	What they receive
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. Receives: Other: D-Glucose beverage as reference food; Other: 15mg of Crocus Sativus as beverage; Other: 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. Receives: Other: D-Glucose beverage as reference food; Other: 15mg of Crocus Sativus as beverage; Other: 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. Receives: Other: D-Glucose beverage as reference food; Other: 15mg of Crocus Sativus as beverage; Other: 30mg of Crocus Sativus as beverage

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 2 hours

Secondary outcomes (2)

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.
Measured: 2 hours
Blood pressure
Useful change in systolic and diastolic blood pressure before and 2-hour after consumption of the three beverages
Measured: 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jun 202226 Jul 2022

First posted2 Aug 2022
Study start6 Jun 2022
Primary completion10 Jul 2022
Study completion26 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Potential Abnormality of Glucose ToleranceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Model description: Crossover, double blind, randomized clinical trial
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05484362
Sponsor's protocol ID: HRBD 58/21.06.2022
Status last verified: Jul 2022
First submitted: 30 Jul 2022
Last updated: 2 Aug 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Acute Effect of Two Doses of Crocus Sativus on Postprandial Glycemia: A Randomized Clinical Trial in Healthy Humans
ClinicalTrials.gov ID: NCT05484362
Acronym / sponsor ID: HRBD 58/21.06.2022
Conditions: Potential Abnormality of Glucose Tolerance, Appetitive Behavior, Blood Pressure
Keywords: Crocus sativus, Blood glucose responses, blood pressure, subjective appetite, blood glucose concentrations
Study type: Interventional
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: Agricultural University of AthensUniversity, hospital or other
Study start: 6 Jun 2022 (actual)
Primary completion: 10 Jul 2022 (actual)
Study completion: 26 Jul 2022 (actual)
First posted: 2 Aug 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 3
Model description: Crossover, double blind, randomized clinical trial

Arm	Type	Receives
Glucose as reference food	Experimental	Other: D-Glucose beverage as reference food, Other: 15mg of Crocus Sativus as beverage, Other: 30mg 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 beverage	Experimental	Other: D-Glucose beverage as reference food, Other: 15mg of Crocus Sativus as beverage, Other: 30mg 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 beverage	Experimental	Other: D-Glucose beverage as reference food, Other: 15mg of Crocus Sativus as beverage, Other: 30mg 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.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (8 listed)

Severe chronic disease (e.g., coronary heart disease, diabetes mellitus, kidney or liver conditions, endocrine conditions)
Gastrointestinal disorders
Pregnancy
Lactation
Competitive sports

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
D-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.	Other	15mg of Crocus Sativus as beverage, 30mg of Crocus Sativus as beverage, Glucose as reference food
15mg 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.	Other	15mg of Crocus Sativus as beverage, 30mg of Crocus Sativus as beverage, Glucose as reference food
30mg 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.	Other	15mg of Crocus Sativus as beverage, 30mg of Crocus Sativus as beverage, Glucose as reference food

Primary outcome

Capillary blood glucose responses
Time frame: 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

2 secondary outcomes

Subjective appetite ratings
Time frame: 2 hours
Blood pressure
Time frame: 2 hours

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Aimilia Papakonstantinou, PhD principal investigator

Agricultural University of Athens

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Capillary blood glucose responses (time frame: 2 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05484362.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.