Status:
ACTIVE_NOT_RECRUITING
Postprandial Effect of Olive Leaf Biscuits and Tea Consumption on Blood Biomarkers in Healthy Individuals
Lead Sponsor:
University of the Aegean
Conditions:
Oxidative Stress
Inflammation Biomarkers
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This randomized controlled nutritional intervention study aims to investigate the bioactivity of dried olive leaves in biscuit and tea preparations, focusing on their postprandial effects on selected ...
Detailed Description
This is the protocol of a randomized controlled nutritional intervention \- clinical study to investigate the bioactivity of preparations (biscuits and tea) with dried olive leaves. This is a nutriti...
Eligibility Criteria
Inclusion
- Healthy, without underlying diseases (e.g. diabetes, cardiovascular, hypertension, hypercholesterolemia, hypertriglyceridemia, morbid obesity with BMI\>40kg/m2)
- Aged 18-65 years at the start of the study
- Signed written consent to participate in the study and access by doctors to their medical history (diseases, medication)
Exclusion
- People with a BMI \>40
- Professional athletes
- People taking contraceptive treatment in the last 3 months
- People with a history of food allergy with hypersensitivity to any of the components of the administered product (e.g. milk protein or allergy-hypersensitivity to plants of the Oleaceae family) People taking supplements (e.g. antioxidants) or drugs that affect intestinal function (e.g. antibiotics) in the last 3 months or medication (hypoglycemic drugs or antihypertensive drugs or diuretics) that may interact with the administered product
- People taking any medication or supplement that may affect metabolism (e.g. GLP-1 analogues and receptor agonists, caffeine supplement, supplements weight loss/gain)
- Pregnant, lactating or menopausal women
- Individuals with substance abuse (drugs) or chronic alcoholism or total daily alcohol intake \> 50 g/d
- Individuals with a chronic condition (history of cardiovascular disease, cancer, diabetes, hypertension, hyperlipidemia, neurological and neuropsychological disorders, active liver disease, severe renal dysfunction, severe stroke and conditions associated with increased risk of bleeding)
- Individuals with any other serious medical condition that may affect the individual's ability to participate in a nutritional intervention study.
- Individuals whose dietary preferences do not allow them to do so (e.g., vegetarians, vegans)
- Individuals who are not willing to comply with the study protocol and the periods of fasting and eating
- Individuals who are considered unreliable by the researcher or have a shorter life expectancy than the expected duration of the study, due to some disease or if they are in any condition that, in the opinion of the researcher, does not allow their safe participation in the study (drug addiction, alcohol abuse)
Key Trial Info
Start Date :
November 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06983145
Start Date
November 20 2024
End Date
September 30 2025
Last Update
May 21 2025
Active Locations (1)
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1
Lab of Human Nutrition and Public Health
Myrina, Limnos, Greece, 81400