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

ConditionsPrediabetes (Insulin Resistance, Impaired Glucose Tolerance)Female Adult Endothelial Function (Reactive Hyperemia)Arterial Stiffness Cognition Oxidative Stress Gut Microbiota Overweight Inflammation Microvascular Function Body Composition

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age20-65

SponsorGeorgia State University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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/m²

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Wild BlueberryExperimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Blood Glucose

Measurement of fasting blood glucose

Time frame

Baseline and 6 weeks

Ambulatory Blood Pressure

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

Time frame

Baseline and 6 weeks

Secondary outcomes

Fasting Insulin

Time frame

Baseline and 6 weeks

Homeostasis model assessment-insulin resistance (HOMA-R)

Calculated as fasting insulin (mU/mL) x fasting glucose (mg/dL)/405

Time frame

Baseline and 6 weeks

Blood Lipid Profile

Measurement of blood lipid profile

Time frame

Baseline and 6 weeks

Gut Microbiota Composition

Analysis of stool sample for determination of absolute levels of bacteria and relative species composition

Time frame

Baseline and 6 weeks

Other outcomes

Reactive Hyperemia Index

Assessment of endothelial function in response to increased shear stress using EndoPAT2000

Time frame

Baseline and 6 weeks

Pulse Wave Velocity

Arterial Stiffness will be assessed by pulse wave velocity using SphygmCor

Time frame

Baseline and 6 weeks

Percent Maximal Microvascular Blood Flow

Micro-vessel blood flow in response to local heating stimulus will be assessed using a Laser Doppler

Time frame

Baseline and 6 weeks

Circulating Markers of Inflammation and Oxidative Stress

Measurement of concentrations of circulating markers of inflammation such as CRP and oxidative stress such as TBARS in blood plasma and serum samples.

Time frame

Baseline and 6 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Georgia State University

Lead sponsor

Wild Blueberry Association of North America

Collaborator

Source ClinicalTrials.gov

Apply now