Wild Blueberries for Gut, Brain, and Cardiometabolic Health in Prediabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Wild Blueberry, Placebo.
- Who it may be relevant to
- Registry conditions: Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Female, Adult, Endothelial Function (Reactive Hyperemia). Basic parameters: 20 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Wild Blueberries for Gut, Brain, and Cardiometabolic Health in Female Adults With Prediabetes.
Overview
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.
Detailed description
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.
Interventions
- Dietary supplement Wild Blueberry
Daily consumption of 22 g of freeze-dried wild blueberry freeze-dried powder for 6 weeks - Dietary supplement Placebo
Daily consumption of 22 g of freeze-dried macronutrient-matched placebo powder for 6 weeks
Primary outcome measures
- Blood Glucose [Time frame: Baseline and 6 weeks]
- Ambulatory Blood Pressure [Time frame: Baseline and 6 weeks]
Secondary outcome measures (12)
- Fasting Insulin [Time frame: Baseline and 6 weeks]
- Homeostasis model assessment-insulin resistance (HOMA-R) [Time frame: Baseline and 6 weeks]
- Blood Lipid Profile [Time frame: Baseline and 6 weeks]
- Gut Microbiota Composition [Time frame: Baseline and 6 weeks]
- Global Cognitive Ability [Time frame: Screening]
- Performance Validity [Time frame: Baseline and 6 weeks]
- Verbal Memory & Recognition [Time frame: Baseline and 6 weeks]
- Cognitive Inhibition [Time frame: Baseline and 6 weeks]
- Cognitive Flexibility [Time frame: Baseline and 6 weeks]
- Working Memory [Time frame: Baseline and 6 weeks]
- Processing Speed [Time frame: Baseline and 6 weeks]
- Associative Memory [Time frame: Baseline and 6 months]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Georgia State University — Atlanta
Publications
- 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. PMID 32337475
- 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. PMID 28283823
- 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. PMID 30022099
- 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. PMID 28402770
- 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. PMID 35458181
- 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 PMID 25578927
Identifiers
NCT: NCT06735651 · H24123