Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)NCT06735651
Wild Blueberries for Gut, Brain, and Cardiometabolic Health in Prediabetes
A study testing Wild Blueberry in people with Prediabetes (Insulin Resistance, Impaired Glucose Tolerance) and Female, run by Georgia State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Female, Adult
- What is being tested?
- Wild Blueberry
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2024to 1 Sep 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Pregnant or Lactating
- Actively participating in a weight loss program
- Currently taking berry supplements or recently participated in another study taking berry supplements
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Georgia State University
Atlanta, Georgia, 30303
Rafaela G Feresin, PhD, 404-413-1233, berries@gsu.edu
Rafaela G Feresin, PhD
About this study
Official title: Wild Blueberries for Gut, Brain, and Cardiometabolic Health in Female Adults With Prediabetes.
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.
Read the 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.
- Conditions
- Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Female, Adult, Endothelial Function (Reactive Hyperemia), Arterial Stiffness, Cognition
- Being tested
- Wild Blueberry, Placebo
- Keywords
- Blueberries, Prediabetes, Insulin Resistance, Functional foods, Dietary intervention, Endothelial function, Vascular function, Cardiovascular health, Metabolic health, Gut microbiota, Cognitive function, Type II diabetes, Microvascular Function, Wild Blueberries
- Medical subject headings
- Prediabetic State, Insulin Resistance, Glucose Intolerance, Hyperemia, Overweight, Inflammation, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wild BlueberryDietary supplement
Daily consumption of 22 g of freeze-dried wild blueberry freeze-dried powder for 6 weeks
PlaceboDietary supplement
Daily consumption of 22 g of freeze-dried macronutrient-matched placebo powder for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Wild Blueberry | Experimental | 22 g of freeze-dried wild blueberry freeze-dried powder per day Receives: Dietary Supplement: Wild Blueberry |
| Placebo | Placebo comparator | 22 g of freeze-dried macronutrient-matched placebo powder per day Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Glucose
Measurement of fasting blood glucose
Measured: Baseline and 6 weeks
Ambulatory Blood Pressure
Assessment of whole-day ambulatory blood pressure during daytime and nighttime periods.
Measured: Baseline and 6 weeks
Secondary outcomes (14)
Fasting Insulin
Measured: Baseline and 6 weeks
Homeostasis model assessment-insulin resistance (HOMA-R)
Calculated as fasting insulin (mU/mL) x fasting glucose (mg/dL)/405
Measured: Baseline and 6 weeks
Blood Lipid Profile
Measurement of blood lipid profile
Measured: Baseline and 6 weeks
Gut Microbiota Composition
Analysis of stool sample for determination of absolute levels of bacteria and relative species composition
Measured: Baseline and 6 weeks
Global Cognitive Ability
Measured using NIH Toolbox Picture Vocabulary test and Oral Reading Recognition
Measured: Screening
Performance Validity
Assessed using Rey 15
Measured: Baseline and 6 weeks
Verbal Memory & Recognition
Measured using Rey Auditory Verbal Learning Test with appropriate alternate forms
Measured: Baseline and 6 weeks
Cognitive Inhibition
Measured using Delis-Kaplan Executive Function System Color Word Interference, and NIH Toolbox Flanker Inhibitory Control and Attention
Measured: Baseline and 6 weeks
Cognitive Flexibility
Assessed using Delis-Kaplan Executive Function System Trails and Verbal Fluency Switching
Measured: Baseline and 6 weeks
Working Memory
Measured using Digit Span and NIH Toolbox List Sorting
Measured: Baseline and 6 weeks
Processing Speed
Measured using NIH Toolbox Pattern Comparison and Oral Symbol Digit tests
Measured: Baseline and 6 weeks
Associative Memory
Measured using NIH Toolbox Face Name Associative Memory Exam and Face Name Associative Memory Exam Delay tests
Measured: Baseline and 6 months
Attention
Assessed using Wechsler Adult Intelligence Scale - IV and Rey Auditory Verbal Learning Test Trial 1.
Measured: Baseline and 6 weeks
Problem-Solving
Assessed using NIH Toolbox Visual Reasoning Test
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start20 Sep 2024
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgia State University
- Sponsor type
- University, hospital or other
- Collaborators
- Wild Blueberry Association of North America
- Responsible party
- Principal investigator, Rafaela G. Feresin, Georgia State University
- Investigators
- Rafaela G Feresin, PhD, Principal investigator, Georgia State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06735651
- Sponsor's protocol ID
- H24123
- Status last verified
- Sep 2026
- First submitted
- 5 Nov 2024
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32337475Miller 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.
PubMed 28283823Biessels 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.
PubMed 30022099Rawshani 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.
PubMed 28402770Krikorian 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.
PubMed 35458181Johnson 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.
PubMed 25578927