Study on the Chronic and Acute Effects of Nordic Berry Beverage on Cognitive Function, Cardiometabolic Risk Markers and Gut Microbiome: A Randomized, Double-blind, Placebo-controlled Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aventure AB
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Cognitive measures
研究概览
简要总结
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.
详细描述
The study will be conducted with a randomized, double-blind, parallel-group (2 arms) placebo-controlled, single-center interventional design. The aim is to investigate the effects on cognitive function and cardiometabolic risk markers after acute and 12 weeks daily intake of a berry product vs. a reference product. The reference will be isocaloric and matched in taste, appearance, volume and macronutrient composition to the active berry product.
Two groups, each of 30 volunteers, are studied. One group of volunteers will consume the berry product while the other group act as control and will consume the reference product.
Each volunteer will be seen for a screening visit as well as one pre- and one post-intervention visit at the clinic. In addition, there will be 2 follow-up calls in between visits. Pre- and post intervention visits will include cognitive assessment with the CANTAB battery (episodic memory and verbal recognition memory), as well as additional cognitive and behavioral tests. Cardiometabolic parameters will be addressed (plasma glucose, insulin, inflammatory markers, blood lipids, body composition) and fecal samples collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 study
排除标准
- •Known to be affected by major neurocognitive disorder/dementia or low score on cognitive screening test (Mini Mental State Examination (MMSE) score less than
- •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 study
- •Concurrent 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
研究组 & 干预措施
Active berry product
Once daily consumption over the period of the study
干预措施: Active berry product (Other)
Reference berry-like product
Once daily consumption over the period of the study
干预措施: Reference berry-like product (Other)
结局指标
主要结局
Cognitive measures
时间窗: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Global cognitive function - assessed by calculating a z-score from the cognitive battery score outcomes
Cognitive measures-memory
时间窗: Change from baseline following 12 weeks daily consumption, compared to control
Episodic memory - assessed using computerized cognitive battery including PAL (paired associates learning) test.
Cognitive measures - memory
时间窗: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Working memory - assessed using computerized cognitive battery including SWM (spatial working memory) test.
Cognitive measures - executive function
时间窗: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Executive function - assessed using computerized cognitive battery including TMT (trail making test) A \& B.
Cognitive measures - attention
时间窗: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Attention, reaction time - assessed using computerized cognitive battery including RTI (reaction time) test.
次要结局
- Self-reported quality of life(Difference from baseline vs control following 12 weeks of daily consumption)
- Biomarkers of lipemia in blood plasma(Difference from baseline vs control following 12 weeks of daily consumption)
- Cardiometabolic risk factor(Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control)
- Body composition(Change from baseline following 12 weeks daily consumption, compared to control)
- Biomarkers of glycemia(Change from baseline following 12 weeks daily consumption, compared to control)
- Biomarkers of inflammation and oxidative stress blood plasma(Difference from baseline vs control following 12 weeks of daily consumption)
- Biomarker endothelial function in blood plasma(Difference from baseline vs control following 12 weeks of daily consumption)
- Circulating plasma biomarkers relating to cognitive function(Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control)
- Subjective memory(Difference from baseline vs control following 12 weeks of daily consumption)
- Biomarkers of liver function in blood plasma(Difference from baseline vs control following 12 weeks of daily consumption)
- Mood measurement(Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control)
- Well-being measurement(Difference from baseline vs control following 12 weeks of daily consumption)
- Biomarkers of glycemia(Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control)