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Clinical Trials/NCT05484362
NCT05484362
Completed
Not Applicable

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

Agricultural University of Athens1 site in 1 country11 target enrollmentStarted: June 6, 2022Last updated:
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ConditionsPotential Abnormality of Glucose ToleranceAppetitive BehaviorBlood Pressure

Overview

Phase
Not Applicable
Status
Completed
Enrollment
11
Locations
1
Primary Endpoint
Capillary blood glucose responses
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Other
Masking
Double (Participant, Investigator)

Masking Description

A researcher not involved in data analyses was responsible for participant allocation and test food consumption.

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Subjective appetite ratings(2 hours)
  • Blood pressure(2 hours)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Aimilia Papakonstantinou

Assistant Professor

Agricultural University of Athens

Study Sites (1)

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