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Study of the Postprandial Effect of Olive Leaf Biscuits and Tea Consumption on Plasma Antioxidant Status, as Well as on Metabolic Syndrome Indicators, in Healthy Individuals
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 biomarkers and plasma antioxidant status. Healthy volunteers aged 18 to 65 from Limnos, Greece, will participate in the study, held at the Human Nutrition Unit of the University of the Aegean. The study will last 15 days and features a cross-over design involving three groups: Control Group: Consumes biscuits made with butter, flour, sugar, and caramel coloring, along with natural mineral water. Intervention Group A: Receives the same biscuits with added dried olive leaf powder, accompanied by the same water. Intervention Group B: Eats the standard biscuits with olive leaf tea instead of water. On each study day, participants will consume their meal over 15 minutes, followed by the liquid within 10 minutes. After a 7-day washout period, the groups will switch treatments for the second phase. The procedure will be repeated on the 15th day, ensuring that all participants experience each condition. Blood samples will be collected before and at 60, 120, and 240 minutes post-meal for analysis. Statistical processing will then be conducted to evaluate the effects on biomarkers and antioxidant status.
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 nutritional intervention - clinical study of cross-over design (cross over design: acute study). The main objective of the study is to investigate the postprandial effect of olive leaves, on selected biomarkers and on the antioxidant status of plasma. The participants of the study will be healthy volunteers, aged 18-65 years, who will come from areas of Greece and will be based on the island of Limnos, in order to be able to be present on the days of the study. The study will be carried out in the specially designed space of the Human Nutrition Unit, University of the Aegean, in collaboration with external doctors. The total duration of the study will be 15 days (3 axes). Participants will be randomly divided into three groups. On the first day, the first group will consume a meal rich in carbohydrates and fats, which will consist of 2-3 biscuits made with butter, flour and sugar and drops of caramel coloring (E150a), along with a glass of natural mineral water with the addition of caramel coloring (E150a) at a refrigerator temperature of \~4°C (control group), the second group 2-3 biscuits made with butter, flour and sugar and dried olive leaf powder, along with a glass of natural mineral water with the addition of caramel coloring (E150a) at a refrigerator temperature of \~4°C (intervention group A) and the third group 2-3 biscuits made with butter, flour and sugar and drops of caramel coloring (E150a), along with a glass of tea made from dried olive leaves and natural mineral water at refrigerator temperature \~4°C (intervention group B). In all groups, the meal (control or intervention) will be consumed first and the liquid (control or intervention) will be consumed immediately afterwards. The total time for the meal (biscuits) will be 15 minutes and in the next 10 minutes, the liquid (olive leaf tea or water with caramel coloring) must also be consumed. After 7 days (washout period), the same volunteers will come to the specially designed area and the procedure will be repeated, with the difference that the control group on day 1 will belong to intervention group A, intervention group A will belong to intervention group B and intervention group B will belong to the control group. Finally, on the 15th day, the procedure will be repeated with the same volunteers, where the control group of the 1st day will now belong to the intervention group B, the intervention group A will belong to the control group and the intervention group B will belong to the intervention group A. On all 3 days, blood will be taken for analysis from the participants before, as well as 60, 120 and 240 minutes after the meals. Statistical processing of the results of the analyses will follow to present data regarding the postprandial levels of selected biomarkers and the antioxidant status of plasma.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
Yes
Lab of Human Nutrition and Public Health
Myrina, Limnos, Greece
Start Date
November 20, 2024
Primary Completion Date
March 11, 2025
Completion Date
September 30, 2025
Last Updated
May 21, 2025
30
ESTIMATED participants
Olive Leaf tea
OTHER
Lead Sponsor
University of the Aegean
NCT07379216
NCT06817252
Data Source & Attribution
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