Blood Pressure Clinical Trial
Official title:
Acute Effect of Two Doses of Crocus Sativus on Postprandial Glycemia: A Randomized Clinical Trial in Healthy Humans
Verified date | July 2022 |
Source | Agricultural University of Athens |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study investigated the effects of two different doses of Crocus Sativus in glucose beverages on glycemic responses.
Status | Completed |
Enrollment | 11 |
Est. completion date | July 26, 2022 |
Est. primary completion date | July 10, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Greece | Agricultural University of Athens | Athens | Attica |
Lead Sponsor | Collaborator |
---|---|
Agricultural University of Athens |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | 2 hours | |
Secondary | Blood pressure | Useful change in systolic and diastolic blood pressure before and 2-hour after consumption of the three beverages | 2 hours |
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