Wild Blueberries for Gut, Brain, and Cardiometabolic Health in Prediabetes

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка Wild Blueberry
  Daily consumption of 22 g of freeze-dried wild blueberry freeze-dried powder for 6 weeks
• Пищевая добавка Placebo
  Daily consumption of 22 g of freeze-dried macronutrient-matched placebo powder for 6 weeks

Первичные конечные точки

• Blood Glucose [Срок оценки: Baseline and 6 weeks]
• Ambulatory Blood Pressure [Срок оценки: Baseline and 6 weeks]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Georgia State University — Atlanta

Публикации

• 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

Идентификаторы

NCT: NCT06735651 · H24123

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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