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Lifestyle strategies that include dietary modification, such as consumption of a plant-based diet, are well recognized in disease prevention and may improve type 2 diabetes. Various components of a plant-based diet may contribute to its beneficial health effects, but there has been keen interest in the possibility that plant polyphenols may have a role. Blueberries are dietary sources of polyphenols, specifically anthocyanins. To date there are few human clinical trials evaluating the beneficial health effects of blueberries in populations with type 2 diabetes. The objective of the study is to determine if freeze-dried blueberries compared to a blueberry placebo will improve cardiometabolic parameters in men with type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blueberry | Experimental | 22 g freeze-dried blueberries |
|
| Placebo | Placebo Comparator | 22 g placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blueberry | Other | 22 g freeze-dried whole blueberry powder |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure | Systolic blood pressure and diastolic blood pressure. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1C | Hemoglobin A1C is a surrogate marker of glycemic control over the preceding 2-3 months. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margaret M. Wilson, MS, RD, CDE | Stratton V.A. Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stratton V.A. Medical Center | Albany | New York | 12208 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32337475 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Blueberry | Blueberry: 22 g freeze-dried whole blueberry powder |
| FG001 | Placebo | Placebo: 22 g placebo blueberry powder |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Blueberry | Blueberry: 22 g freeze-dried whole blueberry powder |
| BG001 | Placebo | Placebo: 22 g placebo blueberry powder |
| 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 | Blood Pressure | Systolic blood pressure and diastolic blood pressure. | Posted | Least Squares Mean | Standard Error | mm Hg | 8 weeks |
|
|
2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Blueberry | 22 g freeze-dried blueberries Blueberry: 22 g freeze-dried whole blueberry powder |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Margaret M. Wilson MS, RD, LD/N, CD/N, CNSC, CDE | Stratton V.A. Medical Center | 518 626-6889 | margaret.wilson2@va.gov |
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| 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 | Jul 6, 2016 | Jul 22, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C000721609 | blueberry extract |
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| Placebo |
| Other |
22 g placebo blueberry powder |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Blood Pressure | Mean | Standard Deviation | mm Hg |
|
|
|
| Secondary | Hemoglobin A1C | Hemoglobin A1C is a surrogate marker of glycemic control over the preceding 2-3 months. | Posted | Least Squares Mean | Standard Error | percent | 8 weeks |
|
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Placebo | 22 g placebo Placebo: 22 g placebo blueberry powder | 0 | 26 | 0 | 26 | 0 | 26 |
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