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Completed
NCT07848464
Cronobióticos Naturales
Conditions: Circadian Rhythm Disruption, Healthy Volunteers
Sex: All
Ages: 35 Years – 55 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 20
Sponsor: Universidad San Sebastián
Location: Universidad San Sebastián Valdivia
Summary
Brief Summary The goal of this clinical trial is to learn if a drink made from native berries of southern Chile can change the body's natural production of melatonin (a hormone that helps control sleep), sleep quality, and some measures of metabolic health in adults aged 35 to 55 years who are overweight (body mass index 25 to 29.9), eat fewer than two servings of fruits or vegetables a day, and have regular sleep. The study takes place in Valdivia, Chile.
The main questions it aims to answer are:
Does drinking the berry drink raise the amount of melatonin the body makes? Does drinking the berry drink change sleep quality, blood sugar, blood fats (lipids), body weight and body composition, and markers of inflammation and oxidative stress? Researchers will compare the berry drink to a placebo (a look-alike drink with no berry extracts) to see if the berry drink changes these measures. Each participant will receive both drinks, one after the other, in random order. Neither the participants nor the study staff will know which drink is being taken at any time.
Participants will:
Attend a screening visit to check if they can join the study (blood pressure, weight, height, waist and hip size, and a health form) Drink 2 small vials of the assigned drink every day for 4 weeks Take no study drink for a 4-week break Drink 2 vials of the other drink every day for 4 more weeks Visit the study site 6 times over 12 weeks, after fasting for 8 to 12 hours before each visit Have their blood pressure, finger-prick blood sugar, and weight checked at every visit At 4 of the visits, give a blood sample, collect a saliva sample at home the night before, have their body composition measured, and fill out questionnaires about health, eating habits, physical activity, and sleep Answer a survey about the taste and acceptance of the drink
Eligibility Criteria
Inclusion Criteria:
* Men and women aged 35 to 55 years Body mass index (BMI) between 25.0 and 29.9 kg/m² Intake of fewer than two servings of fruits and/or vegetables per day Regular sleep pattern, with at least 6 hours of sleep per night Resident of Valdivia, Los Ríos Region, Chile Willing to drink two study vials per day (morning and afternoon/evening) during both 4-week intervention periods Willing to attend the screening visit and all six study visits after an 8- to 12-hour fast Willing to avoid supplements high in antioxidants, polyphenols, vitamins, or melatonin for the entire 12-week study Able to understand the study and provide written informed consent
Exclusion Criteria:
* Diagnosed sleep disorder (e.g., chronic insomnia or sleep apnea) Use of L-tryptophan, exogenous melatonin, hypnotics, anxiolytics, antidepressants, or corticosteroids Use of vitamin supplements or dietary supplements containing maqui, cranberry, goji, or other berries Use of probiotics in any form BMI below 25 or above 30 kg/m², or a body weight change of ±10% in the previous 3 months Blood pressure above 140/90 mmHg Uncontrolled metabolic or chronic disease, based on reference parameters for the condition Pregnancy or breastfeeding Allergy to berries or to any component of the study product Excessive alcohol intake (more than 40 g per day, or about 3 cans of beer per day) Excessive caffeine intake (more than 5 cups per day) Use of anticoagulants
Source: ClinicalTrials.gov (NCT07848464). StuddyBuddy aggregates publicly available trial information.