Blueberries for Gut, Brain, and Cardiometabolic Health in Prediabetes

Last updated: March 18, 2025
Sponsor: Georgia State University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Inflammation

Body Composition

Stress

Treatment

Wild Blueberry

Placebo

Clinical Study ID

NCT06735651
H24123
  • Ages 45-65
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Women aged 45-65 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

Exclusion Criteria:

  • Allergies to berries

  • Use of insulin, antidiabetic, antibiotics, and anti-inflammatory drugs

  • Active cancer, gastrointestinal, renal, thyroid, stage 1 & 2 hypertension and othercardiovascular 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 takingberry supplements

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Wild Blueberry
Phase:
Study Start date:
September 20, 2024
Estimated Completion Date:
June 01, 2025

Study 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 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 blueberry powder improves gut, cardiometabolic, and cognitive function in women with prediabetes. Investigators hypothesize that daily consumption of 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 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.

Connect with a study center

  • Georgia State University

    Atlanta, Georgia 30303
    United States

    Active - Recruiting

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