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NCT06983145

Postprandial Effect of Olive Leaf Biscuits and Tea Consumption on Blood Biomarkers in Healthy Individuals

Sponsor: University of the Aegean

View on ClinicalTrials.gov

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 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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-11-20

Completion Date

2025-09-30

Last Updated

2025-05-21

Healthy Volunteers

Yes

Conditions

Oxidative Stress Inflammation Biomarkers

Interventions

OTHER

Olive Leaf tea

Individuals will consume 2-3 pieces of biscuits with caramel coloring (total 120 g) and a glass (250 mL) of tea (natural mineral water with 1.25 g. dried olive leaves)

Inclusion Criteria: * 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 Criteria: * 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)

Locations (1)

Lab of Human Nutrition and Public Health

Myrina, Limnos, Greece