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Cronobióticos Naturales
Sponsor: Universidad San Sebastián
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
Official title: Cronobióticos Naturales: Innovación en la prevención de Enfermedades crónicas y Mejora Del Equilibrio biológico
Key Details
Gender
All
Age Range
35 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-05-15
Completion Date
2026-09-16
Last Updated
2026-09-30
Healthy Volunteers
Yes
Interventions
Chronobiotic
Proprietary natural chronobiotic juice (ChronoNaturals) made from extracts of native berries of southern Chile, without nanoparticles or artificial additives. It is rich in polyphenols, mainly anthocyanins and phenolic acids, which may support endogenous melatonin production. Participants take two vials of about 30 mL per day (one in the morning and one in the afternoon/evening), providing about 1,000 mg of polyphenols daily, for 4 weeks. The vials are coded to maintain double blinding.
Placebo
Inactive juice without berry extracts, containing no polyphenols from the active formulation. It is matched to the chronobiotic juice in taste, color, and texture and supplied in identical coded vials to maintain double blinding. Participants take two vials of about 30 mL per day (one in the morning and one in the afternoon/evening) for 4 weeks.
Locations (1)
Universidad San Sebastián
Valdivia, Chile