NCT06735651

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Sep 2024Jun 2026

Study Start

First participant enrolled

September 20, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 16, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

March 25, 2026

Status Verified

July 1, 2025

Enrollment Period

1.7 years

First QC Date

November 5, 2024

Last Update Submit

March 23, 2026

Conditions

Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)FemaleAdultEndothelial Function (Reactive Hyperemia)Arterial StiffnessCognitionOxidative StressGut MicrobiotaOverweightInflammationMicrovascular FunctionBody Composition

Keywords

BlueberriesPrediabetesInsulin ResistanceFunctional foodsDietary interventionEndothelial functionVascular functionCardiovascular healthMetabolic healthGut microbiotaCognitive functionType II diabetesMicrovascular FunctionWild Blueberries

Outcome Measures

Primary Outcomes (2)

  • Blood Glucose

    Measurement of fasting blood glucose

    Baseline and 6 weeks

  • Ambulatory Blood Pressure

    Assessment of whole-day ambulatory blood pressure during daytime and nighttime periods.

    Baseline and 6 weeks

Secondary Outcomes (14)

  • Fasting Insulin

    Baseline and 6 weeks

  • Homeostasis model assessment-insulin resistance (HOMA-R)

    Baseline and 6 weeks

  • Blood Lipid Profile

    Baseline and 6 weeks

  • Gut Microbiota Composition

    Baseline and 6 weeks

  • Global Cognitive Ability

    Screening

  • +9 more secondary outcomes

Other Outcomes (6)

  • Reactive Hyperemia Index

    Baseline and 6 weeks

  • Pulse Wave Velocity

    Baseline and 6 weeks

  • Percent Maximal Microvascular Blood Flow

    Baseline and 6 weeks

  • +3 more other outcomes

Study Arms (2)

Wild Blueberry

EXPERIMENTAL

22 g of freeze-dried wild blueberry freeze-dried powder per day

Dietary Supplement: Wild Blueberry

Placebo

PLACEBO COMPARATOR

22 g of freeze-dried macronutrient-matched placebo powder per day

Dietary Supplement: Placebo

Interventions

Wild BlueberryDIETARY_SUPPLEMENT

Daily consumption of 22 g of freeze-dried wild blueberry freeze-dried powder for 6 weeks

Wild Blueberry
PlaceboDIETARY_SUPPLEMENT

Daily consumption of 22 g of freeze-dried macronutrient-matched placebo powder for 6 weeks

Placebo

Eligibility Criteria

Age20 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgia State University

Atlanta, Georgia, 30303, United States

RECRUITING

Related Publications (6)

  • 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: 32337475BACKGROUND

  • 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: 28283823BACKGROUND

  • 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: 30022099BACKGROUND

  • 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: 28402770BACKGROUND

  • 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: 35458181BACKGROUND

  • 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.

    PMID: 25578927BACKGROUND

MeSH Terms

Conditions

Prediabetic StateInsulin ResistanceGlucose IntoleranceHyperemiaOverweightInflammationDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinismHyperglycemiaVascular DiseasesCardiovascular DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • Rafaela G Feresin, PhD

    Georgia State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rafaela G Feresin, PhD

CONTACT

404-413-1233berries@gsu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 5, 2024

First Posted

December 16, 2024

Study Start

September 20, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

March 25, 2026

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)