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| Name | Class |
|---|---|
| Wild Blueberry Association of North America | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wild Blueberry | Experimental | 22 g of freeze-dried wild blueberry freeze-dried powder per day |
|
| Placebo | Placebo Comparator | 22 g of freeze-dried macronutrient-matched placebo powder per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wild Blueberry | Dietary Supplement | Daily consumption of 22 g of freeze-dried wild blueberry freeze-dried powder for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood Glucose | Measurement of fasting blood glucose | Baseline and 6 weeks |
| Ambulatory Blood Pressure | Assessment of whole-day ambulatory blood pressure during daytime and nighttime periods. | Baseline and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Insulin | Baseline and 6 weeks | |
| Homeostasis model assessment-insulin resistance (HOMA-R) | Calculated as fasting insulin (mU/mL) x fasting glucose (mg/dL)/405 | Baseline and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Reactive Hyperemia Index | Assessment of endothelial function in response to increased shear stress using EndoPAT2000 | Baseline and 6 weeks |
| Pulse Wave Velocity | Arterial Stiffness will be assessed by pulse wave velocity using SphygmCor |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rafaela G Feresin, PhD | Contact | 404-413-1233 | berries@gsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Rafaela G Feresin, PhD | Georgia State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgia State University | Recruiting | Atlanta | Georgia | 30303 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32337475 | Background | Stote KS, Wilson MM, Hallenbeck D, Thomas K, Rourke JM, Sweeney MI, Gottschall-Pass KT, Gosmanov AR. Effect of Blueberry Consumption on Cardiometabolic Health Parameters in Men with Type 2 Diabetes: An 8-Week, Double-Blind, Randomized, Placebo-Controlled Trial. Curr Dev Nutr. 2020 Mar 9;4(4):nzaa030. doi: 10.1093/cdn/nzaa030. eCollection 2020 Apr. | |
| 28283823 |
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| Placebo | Dietary Supplement | Daily consumption of 22 g of freeze-dried macronutrient-matched placebo powder for 6 weeks |
|
| Blood Lipid Profile | Measurement of blood lipid profile | Baseline and 6 weeks |
| Gut Microbiota Composition | Analysis of stool sample for determination of absolute levels of bacteria and relative species composition | Baseline and 6 weeks |
| Global Cognitive Ability | Measured using NIH Toolbox Picture Vocabulary test and Oral Reading Recognition | Screening |
| Performance Validity | Assessed using Rey 15 | Baseline and 6 weeks |
| Verbal Memory & Recognition | Measured using Rey Auditory Verbal Learning Test with appropriate alternate forms | Baseline and 6 weeks |
| Cognitive Inhibition | Measured using Delis-Kaplan Executive Function System Color Word Interference, and NIH Toolbox Flanker Inhibitory Control and Attention | Baseline and 6 weeks |
| Cognitive Flexibility | Assessed using Delis-Kaplan Executive Function System Trails and Verbal Fluency Switching | Baseline and 6 weeks |
| Working Memory | Measured using Digit Span and NIH Toolbox List Sorting | Baseline and 6 weeks |
| Processing Speed | Measured using NIH Toolbox Pattern Comparison and Oral Symbol Digit tests | Baseline and 6 weeks |
| Associative Memory | Measured using NIH Toolbox Face Name Associative Memory Exam and Face Name Associative Memory Exam Delay tests | Baseline and 6 months |
| Attention | Assessed using Wechsler Adult Intelligence Scale - IV and Rey Auditory Verbal Learning Test Trial 1. | Baseline and 6 weeks |
| Problem-Solving | Assessed using NIH Toolbox Visual Reasoning Test | Baseline and 6 weeks |
| Baseline and 6 weeks |
| Percent Maximal Microvascular Blood Flow | Micro-vessel blood flow in response to local heating stimulus will be assessed using a Laser Doppler | Baseline and 6 weeks |
| Circulating Markers of Inflammation and Oxidative Stress | Measurement of concentrations of circulating markers of inflammation such as CRP and oxidative stress such as TBARS in blood plasma and serum samples. | Baseline and 6 weeks |
| Urinary Polyphenolic Metabolites | 24-hour urine collection samples will be assessed for polyphenol metabolites | Baseline and 6 weeks |
| Body Fat | DEXA will be used to assess body fat. | Baseline and 6 weeks |
| Miller MG, Hamilton DA, Joseph JA, Shukitt-Hale B. Dietary blueberry improves cognition among older adults in a randomized, double-blind, placebo-controlled trial. Eur J Nutr. 2018 Apr;57(3):1169-1180. doi: 10.1007/s00394-017-1400-8. Epub 2017 Mar 10. |
| 30022099 | Background | Biessels GJ, Despa F. Cognitive decline and dementia in diabetes mellitus: mechanisms and clinical implications. Nat Rev Endocrinol. 2018 Oct;14(10):591-604. doi: 10.1038/s41574-018-0048-7. |
| 28402770 | Background | Rawshani A, Rawshani A, Franzen S, Eliasson B, Svensson AM, Miftaraj M, McGuire DK, Sattar N, Rosengren A, Gudbjornsdottir S. Mortality and Cardiovascular Disease in Type 1 and Type 2 Diabetes. N Engl J Med. 2017 Apr 13;376(15):1407-1418. doi: 10.1056/NEJMoa1608664. |
| 35458181 | Background | Krikorian R, Skelton MR, Summer SS, Shidler MD, Sullivan PG. Blueberry Supplementation in Midlife for Dementia Risk Reduction. Nutrients. 2022 Apr 13;14(8):1619. doi: 10.3390/nu14081619. |
| 25578927 | Background | Johnson SA, Figueroa A, Navaei N, Wong A, Kalfon R, Ormsbee LT, Feresin RG, Elam ML, Hooshmand S, Payton ME, Arjmandi BH. Daily blueberry consumption improves blood pressure and arterial stiffness in postmenopausal women with pre- and stage 1-hypertension: a randomized, double-blind, placebo-controlled clinical trial. J Acad Nutr Diet. 2015 Mar;115(3):369-377. doi: 10.1016/j.jand.2014.11.001. Epub 2015 Jan 8. |
| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D007333 | Insulin Resistance |
| D018149 | Glucose Intolerance |
| D006940 | Hyperemia |
| D050177 | Overweight |
| D007249 | Inflammation |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
| D006943 | Hyperglycemia |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
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