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Recruiting NCT05693441

Study on the Chronic and Acute Effects of Nordic Berry Beverage on Cognitive Function

Conditions: Age-related Cognitive Decline

Sex: All
Ages: 60 Years – 85 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 60
Sponsor: Aventure AB

Location: Sweden

Summary

The aim of the current study is to investigate whether acute and 12-weeks daily intake of Nordic berries can improve cognitive abilities of adults without cognitive disease, and whether the effect can be linked to changes in metabolic parameters.

Eligibility Criteria

Inclusion Criteria:Age 60-85 years.Capable and willing to give written informed consent.Capable and willing to perform cognitive testing in Swedish (mastering the Swedish language, functional vision and hearing or the use of visual or hearing aids during testing).Capable and willing to ingest the study beverage for 12 weeks and to follow the instructions given.Agree to maintain consistent dietary habits and physical activity levels for the duration of the studyExclusion Criteria:Known to be affected by major neurocognitive disorder/dementia or low score on cognitive screening test (Mini Mental State Examination (MMSE) score less than 24.Affected by other medical condition(s) or medication(s) known to significantly affect cognitive function.Past history of brain damage, significant head trauma (including loss of consciousness as a result), brain surgery or stroke.Underweight (BMI <18.5).Significant psychiatric disorders with current symptoms.Type 1 diabetes, recently diagnosis of Type 2 diabetes (<12 months) or ongoing insulin treatment.Ongoing treatment for malignancy*.Significant change in medication over the last 3 months.Undergoing antibiotic therapy for the last 3 months prior to inclusion in the study.Blood donation before (3 months) or during the study period.Planned major intervention in health care or change in medication over the next 3 months (study period).Currently active smoker or regular use of other nicotine products.Drug or alcohol abuse.Conditions with major impact on the gastrointestinal tract (such as Crohn's disease, ulcerative colitis, diagnosed gluten intolerance, undertaken intestinal resection or weight loss surgery).Allergy / intolerance to berries or other ingredients in the study products (i.e., colorants, aromas, starch).Vegetarians / vegans.Daily, regular high consumption (approximately 1 dl or more per day) of berries or juices / marmalade / products with high content of bilberries and lingonberries. (Can be recruited if consumption has ceased to less than 5 grams of berries per day at least 1 month before visit 1.).Taking supplements with potential cognitive effects (e.g., omega-3, ginko biloba, Souvenaid), or containing grape and berry extracts or probiotics (capsules or ProViva). (Can be recruited if this intake ceases at least one month before visit 1).Planned longer absence/vacation during the next 3 months (study period).Sharing household with someone participating in the current studyConcurrent participation in other clinical intervention trials (dietary/pharmacological).Other reasons that make the SD in consultation with the PI deem the person inappropriate to include. *basalioma exempt from exclusion criteria

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05693441). StuddyBuddy aggregates publicly available trial information.