Wild Blueberries for Gut, Brain, and Cardiometabolic Health in Prediabetes
NCT ID: NCT06735651
Last Updated: 2025-07-30
Study Results
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Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2024-09-20
2026-06-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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Wild Blueberry
22 g of freeze-dried wild blueberry freeze-dried powder per day
Wild Blueberry
Daily consumption of 22 g of freeze-dried wild blueberry freeze-dried powder for 6 weeks
Placebo
22 g of freeze-dried macronutrient-matched placebo powder per day
Placebo
Daily consumption of 22 g of freeze-dried macronutrient-matched placebo powder for 6 weeks
Interventions
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Wild Blueberry
Daily consumption of 22 g of freeze-dried wild blueberry freeze-dried powder for 6 weeks
Placebo
Daily consumption of 22 g of freeze-dried macronutrient-matched placebo powder for 6 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* Smoking
* 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
45 Years
65 Years
FEMALE
No
Sponsors
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Wild Blueberry Association of North America
OTHER
Georgia State University
OTHER
Responsible Party
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Rafaela G. Feresin
Associate Professor
Principal Investigators
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Rafaela G Feresin, PhD
Role: PRINCIPAL_INVESTIGATOR
Georgia State University
Locations
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Georgia State University
Atlanta, Georgia, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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H24123
Identifier Type: -
Identifier Source: org_study_id
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