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Completed

NCT Number: NCT05484362

Acute Effect of Crocus Sativus on Postprandial Glycemia

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

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Key information

Conditions

Potential Abnormality of Glucose Tolerance Appetitive Behavior Behavior Behavior, Animal Blood Pressure

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Agricultural University of Athens

Athens, Attica, 11855, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

D-Glucose beverage as reference food

Other

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 beverage

Other

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 beverage

Other

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.

Primary outcomes

  1. 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

  1. Subjective appetite ratings

    Time frame: 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

    Time frame: 2 hours

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

Sponsors and collaborators

Lead sponsor

Agricultural University of Athens

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 2, 2022
Registry last updated
Aug 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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