Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 6026-51000-012-06S | Other Grant/Funding Number | USDA-ARS | |
| P20GM109096 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| United States Department of Agriculture (USDA) | FED |
| National Institute of General Medical Sciences (NIGMS) | NIH |
Not provided
Not provided
Not provided
Not provided
This is a research study about the effects of blueberries on the health of children who do not eat much fruits and vegetables. By doing this study, we hope to find out what nutrients from blueberries appear in the blood and urine of the child
This is a double blinded randomized control trial aiming to characterize the profile of polyphenol-derived metabolites in plasma and urine for children ages 11-12 years supplemented short term with wild blueberry powder. The study will assess if a short-term supplementation (5 days) with wild blueberry powder impacts immune responses as well as markers for cardiovascular and bone health. Up to 44 children will be recruited. The participants will attend three visits at Arkansas Children's Nutrition Center.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wild Blueberry Supplement | Active Comparator | 30 grams of wild blueberry powder per day in foods items provided to them |
|
| Placebo supplement | Placebo Comparator | Food items will be provided to them without the wild blueberry power. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wild blueberry containing foods | Dietary Supplement | Foods that contain wild blueberry supplement to deliver up to 30 grams of blueberry powder |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phenolic Acid Metabolites Measured in Plasma and Urine After Dietary Intervention | Fasting Blood and urine were collected at visit two and three following an overnight fasting. At visit three, children consumed a single dose of the study product and plasma and urine were collected | Measurements were conducted hourly for 5 hours; the cumulative number of metabolites characterized over the 5 hours is reported |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Percentage of Lymphocytes Cluster of Differentiation 4 (CD4), Lymphocytes Cluster of Differentiation 8 (CD8) and Natural Killer (NK) Cells | Mitogen stimulated blood will be stained with combinations of fluorochrome-labeled antibodies and analyzed by flow cytometry. Absolute and relative number of CD4, lymphocytes CD8 and natural killer (NK) will be compared between groups. | up to 2 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eva Diaz, MD | Arkansas Children's Reserach Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Nutrition Center | Little Rock | Arkansas | 72202 | United States |
After enrollment, the children were placed on a low-polyphenol diet for 48 hours. Following this period, they were assigned to consume either wild-blueberry products (n = 22) or placebo-containing products (n = 22).
Forty-four children were enrolled at the Arkansas Children's Nutrition Center, with the first participant enrolled on April 23, 2021, and the last participant on August 4, 2022
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Wild Blueberry Supplement | 30 grams of wild blueberry powder per day in food items provided to participants Wild blueberry containing foods: Foods that contain wild blueberry supplement to deliver up to 30 grams of blueberry powder |
| FG001 | Placebo Supplement | Food items were provided to study participants without the wild blueberry power. Placebo containing foods: Foods that do not contain the blueberry powder but a placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Wild Blueberry Supplement | 30 grams of wild blueberry powder per day in foods items provided to study participants Wild blueberry containing foods: Foods that contain wild blueberry supplement to deliver up to 30 grams of blueberry powder |
| BG001 | Placebo Supplement |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Phenolic Acid Metabolites Measured in Plasma and Urine After Dietary Intervention | Fasting Blood and urine were collected at visit two and three following an overnight fasting. At visit three, children consumed a single dose of the study product and plasma and urine were collected | Phenolic-derived metabolites were characterized in the samples using an ultra-high performance liquid chromatography method coupled with mass-spectrometry/mass spectrometry multiple reactions monitoring | Posted | Number | Counts of metabolites | Measurements were conducted hourly for 5 hours; the cumulative number of metabolites characterized over the 5 hours is reported |
|
1 year, 4 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Wild Blueberry Supplement | 30 grams of wild blueberry powder per day in foods items provided to them Wild blueberry containing foods: Foods that contain wild blueberry supplement to deliver up to 30 grams of blueberry powder |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| High blood pressure | General disorders | Systematic Assessment | Blood pressure marked as elevated |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eva C. Diaz, Principal Investigator | University of Arkansas for Medical Sciences and Arkansas Children's Nutrition Ce | 5013643056 | ecdiazfuentes@uams.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 3, 2021 | May 8, 2025 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
Double blinded randomized control
| Placebo containing foods | Dietary Supplement | Foods that do not contain the blueberry powder but a placebo |
|
| T-lymphocyte Responsiveness to Immune Stressors | Blood will be collected following an overnight fast after 5 days on the intervention. Whole blood will be cultured and cells stressed with E. coli lipopolysaccharide (LPS) to induce cytokine release from immune cells. Cytokines will be assayed using electrochemiluminescence based detection platform with multiplexed immunoassays, and their levels compared between study groups. | up to 2 weeks |
| Endothelial Function by Brachial Artery Flow Mediated Dilation | Endothelial-dependent flow-mediated vasodilation of the brachial artery in the fasting state was measured using high resolution ultrasound at enrollment and after 5 days on the intervention. This technology uses sound waves (ultrasound) to visualize the diameter of the brachial artery. A baseline image of the brachial artery will be recorded at rest. A blood pressure cuff will be placed around the lower arm and the cuff will be inflated to 50 mmHg above systolic pressure for 5 minutes, followed by rapid deflation of the cuff. The diameter of the brachial artery will be measured from ultrasound images captured throughout the 8 minute recording protocol. The percent change in the brachial artery will be compared between and within groups. | up to 2 weeks |
Food items without wild blueberry power were provided to study participants. Placebo containing foods: Foods that do not contain the blueberry powder but a placebo |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race was assessed per NIH criteria | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| BMI percentile | Anthropometric measurements, including body weight and height, were obtained using standardized techniques, with the children wearing light clothing and no shoes. All measurements were taken in duplicate, or in triplicate if the initial measures did not meet acceptable agreement. Age-, sex-, and height-specific body mass index percentiles were calculated using growth charts from the CDC. | Mean | Standard Deviation | percentile |
|
| Systolic blood pressure percentile | Blood pressure was measure following the 2017 guidelines from the American Academy of Pediatrics. Blood pressure percentiles were calculated using reference standards to allow comparisons across children of all ages, heights, and sex. | Mean | Standard Deviation | percentile |
|
| Diastolic blood pressure percentile | Blood pressure was measure following the 2017 guidelines from the American Academy of Pediatrics. Blood pressure percentiles were calculated using reference standards to allow comparisons across children of all ages, heights, and sex. | Mean | Standard Deviation | percentile |
|
| Peak VO2 | A graded exercise test was performed to determine peak oxygen uptake (peak VO2). A bicycle fitness test was conducted, during which the resistance of the stationary bicycle was gradually increased. The children were told that they could stop the test at any time if they did not wish to continue but were encouraged to perform maximally. During the test, the children wore an indirect calorimetry face mask to assess their oxygen uptake (VO2), carbon dioxide production (VCO2), and respiratory exchange ratio (RER; VCO2/VO2). Peak VO2 (ml/min) was normalized per body weight. | Mean | Standard Deviation | ml/kg/min |
|
| Flow mediated dilation of the brachial artery | Endothelial function was measured during visits #2 using ultrasound (GE Vivid 7 Ultrasound system with 5.0-13.0 MHz linear transducer, GE Healthcare, Chicago, IL, USA) to assess brachial artery flow-mediated dilation (FMD). This technology used sound waves (ultrasound) to visualize the diameter of the brachial artery. A baseline image of the brachial artery was recorded at rest. | Flow mediated dilation of the brachial artery (%, FMD) were taken at visit 2 before the participants received the study products. Six participants dropped out of the study or were lost to follow-up by visit 2. Additionally, two FMD measurements were either unsuccessful or did not meet the quality criteria for inclusion in the analysis, resulting in a total of 36 baseline FMDs. There are currently no reference standards for FMD in children. | Mean | Standard Deviation | Percentage of artery diameter |
|
| OG001 | Placebo Supplement | Food items without the wild blueberry power were provided to study participants, Placebo containing foods: Foods that do not contain the blueberry powder but a placebo |
|
|
| Secondary | Number and Percentage of Lymphocytes Cluster of Differentiation 4 (CD4), Lymphocytes Cluster of Differentiation 8 (CD8) and Natural Killer (NK) Cells | Mitogen stimulated blood will be stained with combinations of fluorochrome-labeled antibodies and analyzed by flow cytometry. Absolute and relative number of CD4, lymphocytes CD8 and natural killer (NK) will be compared between groups. | Not Posted | up to 2 weeks | Participants |
| Secondary | T-lymphocyte Responsiveness to Immune Stressors | Blood will be collected following an overnight fast after 5 days on the intervention. Whole blood will be cultured and cells stressed with E. coli lipopolysaccharide (LPS) to induce cytokine release from immune cells. Cytokines will be assayed using electrochemiluminescence based detection platform with multiplexed immunoassays, and their levels compared between study groups. | Not Posted | up to 2 weeks | Participants |
| Secondary | Endothelial Function by Brachial Artery Flow Mediated Dilation | Endothelial-dependent flow-mediated vasodilation of the brachial artery in the fasting state was measured using high resolution ultrasound at enrollment and after 5 days on the intervention. This technology uses sound waves (ultrasound) to visualize the diameter of the brachial artery. A baseline image of the brachial artery will be recorded at rest. A blood pressure cuff will be placed around the lower arm and the cuff will be inflated to 50 mmHg above systolic pressure for 5 minutes, followed by rapid deflation of the cuff. The diameter of the brachial artery will be measured from ultrasound images captured throughout the 8 minute recording protocol. The percent change in the brachial artery will be compared between and within groups. | Posted | Mean | Standard Deviation | percentage change in arterial diameter | up to 2 weeks |
|
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 2 |
| 22 |
| EG001 | Placebo Supplement | Food items will be provided to them without the wild blueberry power. Placebo containing foods: Foods that do not contain the blueberry powder but a placebo | 0 | 22 | 0 | 22 | 2 | 22 |
|
| Gastrointestinal symptoms | Gastrointestinal disorders | Non-systematic Assessment | Nausea and / or vomiting |
|
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|