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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
30
Daily consumption of 22 g of freeze-dried wild blueberry freeze-dried powder for 6 weeks
Daily consumption of 22 g of freeze-dried macronutrient-matched placebo powder for 6 weeks
Georgia State University
Atlanta, Georgia, United States
RECRUITINGBlood Glucose
Measurement of fasting blood glucose
Time frame: Baseline and 6 weeks
Ambulatory Blood Pressure
Assessment of whole-day ambulatory blood pressure during daytime and nighttime periods.
Time frame: Baseline and 6 weeks
Fasting Insulin
Time frame: Baseline and 6 weeks
Homeostasis model assessment-insulin resistance (HOMA-R)
Calculated as fasting insulin (mU/mL) x fasting glucose (mg/dL)/405
Time frame: Baseline and 6 weeks
Blood Lipid Profile
Measurement of blood lipid profile
Time frame: Baseline and 6 weeks
Gut Microbiota Composition
Analysis of stool sample for determination of absolute levels of bacteria and relative species composition
Time frame: Baseline and 6 weeks
Global Cognitive Ability
Measured using NIH Toolbox Picture Vocabulary test and Oral Reading Recognition
Time frame: Screening
Performance Validity
Assessed using Rey 15
Time frame: Baseline and 6 weeks
Verbal Memory & Recognition
Measured using Rey Auditory Verbal Learning Test with appropriate alternate forms
Time frame: Baseline and 6 weeks
Cognitive Inhibition
Measured using Delis-Kaplan Executive Function System Color Word Interference, and NIH Toolbox Flanker Inhibitory Control and Attention
Time frame: Baseline and 6 weeks
Cognitive Flexibility
Assessed using Delis-Kaplan Executive Function System Trails and Verbal Fluency Switching
Time frame: Baseline and 6 weeks
Working Memory
Measured using Digit Span and NIH Toolbox List Sorting
Time frame: Baseline and 6 weeks
Processing Speed
Measured using NIH Toolbox Pattern Comparison and Oral Symbol Digit tests
Time frame: Baseline and 6 weeks
Associative Memory
Measured using NIH Toolbox Face Name Associative Memory Exam and Face Name Associative Memory Exam Delay tests
Time frame: Baseline and 6 months
Attention
Assessed using Wechsler Adult Intelligence Scale - IV and Rey Auditory Verbal Learning Test Trial 1.
Time frame: Baseline and 6 weeks
Problem-Solving
Assessed using NIH Toolbox Visual Reasoning Test
Time frame: Baseline and 6 weeks
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