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临床试验/NCT06735651
NCT06735651招募中不适用

Wild Blueberries for Gut, Brain, and Cardiometabolic Health in Female Adults With Prediabetes.

Georgia State University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年9月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Blood Glucose

研究概览

简要总结

The goal of this clinical trial is to determine the effectiveness of using a freeze-dried wild blueberry powder on cardiometabolic health, cognitive function, and gut microbiota composition in adult women with prediabetes.

详细描述

In the U.S., 35.3 million adults have type 2 diabetes mellitus (T2DM) and 96 million have prediabetes. Eight out of 10 people with T2DM die from cardiovascular disease. People with T2DM also have a 50% higher risk of developing dementia compared to healthy counterparts. Further, studies show that gut microbes play a major role in the development of T2DM. Prevention and treatment of T2DM focus on lifestyle changes including dietary modifications such as increased consumption of deep-colored fruits like berries. Blueberries are rich in fiber and phytochemicals and have several health benefits. We and others have shown that blueberry intake improves heart health in healthy men, hypertensive postmenopausal women, and men and women with metabolic syndrome. Yet, a comprehensive study in women with prediabetes that measures changes in cognitive performance and the underlying heart and gut health has not been conducted to date. Thus, the overall objective of this study is to investigate and bring forth evidence that wild blueberries improve gut, cardiometabolic, and cognitive function in women with prediabetes.

Therefore, this pilot six-week randomized, placebo-controlled parallel-arm clinical trial aims to investigate whether daily consumption of 22 g of freeze-dried wild blueberry powder improves gut, cardiometabolic, and cognitive function in women with prediabetes. Investigators hypothesize that daily consumption of wild blueberries will improve cardiometabolic parameters, gut dysbiosis, and cognitive impairments in our study population. To test these hypotheses, the following specific aims are proposed. To investigate whether daily consumption of 22 g of freeze-dried wild blueberry powder:

  • Reduces levels of fasting blood glucose (FBG), insulin, and HOMA-IR (homeostatic model assessment of insulin resistance) and improves lipid profile in women with prediabetes.
  • Reduces blood pressure and improves endothelial function in women with prediabetes.
  • Improves cognitive function (verbal memory and executive functions [inhibition, working memory, cognitive flexibility]) in women with prediabetes.
  • Favorably modulates gut microbiota composition in women with prediabetes.
  • Improves serum markers of oxidative stress and inflammation in women with prediabetes.

Additionally, whether changes in the gut microbiota are associated with changes in cardiometabolic and cognitive function outcomes and whether changes in cardiometabolic outcomes are associated with changes in cognitive function parameters will be explored.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Women aged 20-65 years old
  • •Prediabetes (fasting blood glucose 100-125 mg/dL and/or HbA1c percentage between 5.7-6.4)
  • •Body Mass Index between 25-30 kg/m^2

排除标准

  • •Allergies to berries
  • •Use of insulin, antidiabetic, antibiotics, and anti-inflammatory drugs
  • •Active cancer, gastrointestinal, renal, thyroid, stage 1 & 2 hypertension and other cardiovascular diseases, neurological diseases, or severe head injury
  • •Consumes greater than 2 alcoholic beverages per day
  • •Consumes antioxidant, probiotic, and prebiotic supplements
  • •Pregnant or Lactating
  • •Actively participating in a weight loss program
  • •Currently taking berry supplements or recently participated in another study taking berry supplements

研究组 & 干预措施

Placebo

Placebo Comparator

22 g of freeze-dried macronutrient-matched placebo powder per day

干预措施: Placebo (Dietary Supplement)

Wild Blueberry

Experimental

22 g of freeze-dried wild blueberry freeze-dried powder per day

干预措施: Wild Blueberry (Dietary Supplement)

结局指标

主要结局

Blood Glucose

时间窗: Baseline and 6 weeks

Measurement of fasting blood glucose

Ambulatory Blood Pressure

时间窗: Baseline and 6 weeks

Assessment of whole-day ambulatory blood pressure during daytime and nighttime periods.

次要结局

  • Problem-Solving(Baseline and 6 weeks)
  • Blood Lipid Profile(Baseline and 6 weeks)
  • Fasting Insulin(Baseline and 6 weeks)
  • Homeostasis model assessment-insulin resistance (HOMA-R)(Baseline and 6 weeks)
  • Associative Memory(Baseline and 6 months)
  • Gut Microbiota Composition(Baseline and 6 weeks)
  • Global Cognitive Ability(Screening)
  • Performance Validity(Baseline and 6 weeks)
  • Verbal Memory & Recognition(Baseline and 6 weeks)
  • Working Memory(Baseline and 6 weeks)
  • Processing Speed(Baseline and 6 weeks)
  • Cognitive Inhibition(Baseline and 6 weeks)
  • Cognitive Flexibility(Baseline and 6 weeks)
  • Attention(Baseline and 6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rafaela G. Feresin

Associate Professor

Georgia State University

研究点 (1)

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