Back to resultsEffect of Blueberry Consumption on Metabolic Syndrome & DNA Damage
Primary Purpose
Metabolic Syndrome, Insulin Resistance, DNA Damage
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blueberry Powder
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Syndrome focused on measuring insulin, diabetes, obesity, DNA damage, metabolic syndrome
Eligibility Criteria
Inclusion criteria:
- Age 30-60 years;
- BMI > 30;
- Blood pressure <140/90 mmHg without antihypertensive medicines or with a stable dose of antihypertensive medicines (no change in last 3 months).;
- Insulin resistance (HOMA/IR) > 2.0;
- Willing to restrict intake of high polyphenol-containing foods during the trial period;
- Willing to forego intake of nutritional supplements other than a multivitamin;
- Willing to maintain their current daily level of exercise throughout the study.
Exclusion criteria:
- Known diabetes mellitus according to the 2013 ADA criteria;
- Medications known to affect glucose metabolism;
- Weight loss pharmacotherapy;
- Lipid-lowering medication;
- Untreated thyroid or chronic liver, renal, or cardiovascular disease;
- Smoking;
- Pregnancy- a negative urine pregnancy test will be documented for any women participants of childbearing age prior to enrollment.
- History of allergic reactions to blueberries.
- Any pathological condition known to alter white blood cell count over the previous 6 months;
- Exposure to drugs known to cause mutations or radiation within the previous 6 months;
- Alcohol consumption greater than 2 drinks/d for males and 1 drink/d for females.
Sites / Locations
- Children's Hospital & Research Center Oakland
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Blueberry Powder
Placebo Powder
Arm Description
The intervention group will receive the Blueberry freeze-dried powder equivalent to 1 cup of whole Blueberries twice a day for 8 weeks (i.e. 2 cups/day).
The placebo group will receive placebo powder in the same amounts for the same duration.
Outcomes
Primary Outcome Measures
DNA damage in peripheral blood mononuclear cells
DNA double-stranded breaks (DSBs) will be measured.
Secondary Outcome Measures
Insulin resistance
Insulin resistance will be measured by a 2-hr glucose tolerance test.
Full Information
NCT ID
NCT02075307
First Posted
February 27, 2014
Last Updated
December 22, 2020
Sponsor
UCSF Benioff Children's Hospital Oakland
Collaborators
U.S. Highbush Blueberry Council, USDA Agricultural Research Station in Albany, CA
1. Study Identification
Unique Protocol Identification Number
NCT02075307
Brief Title
Effect of Blueberry Consumption on Metabolic Syndrome & DNA Damage
Official Title
Highbush Blueberries, the DNA-damage of Obesity, Somatic Mutations and Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
April 4, 2017 (Actual)
Study Completion Date
April 4, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCSF Benioff Children's Hospital Oakland
Collaborators
U.S. Highbush Blueberry Council, USDA Agricultural Research Station in Albany, CA
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Obesity usually brings with it disturbances in the body that increase the chances of developing serious diseases like diabetes and cancer. These disturbances include one or more symptoms of a condition called "metabolic syndrome" that often leads to diabetes. High levels of damage to the DNA that makes up our chromosomes have also been observed in obese people. It is possible that these two disturbances are connected. The goal of this project is to test this whether consumption of blueberries will improve these abnormalities.
Detailed Description
Unbalanced diets rich in refined carbohydrate calories, saturated fats, and trans fats, but low in vitamins, minerals, fiber, polyphenolics and ω-3 fatty acids are common in the United States, particularly among the obese. Insulin resistance and high levels of DNA damage commonly accompany obesity. There also appears to be a relationship between oxidative DNA-damage and biomarkers that characterize metabolic syndrome. The bioactivity of blueberries is usually attributed to their high content of polyphenolics which can reduce oxidative DNA damage. Since oxidative damage to mitochondrial DNA is a suggested causal factor leading to increased insulin resistance, we will test if blueberry consumption can be an ameliorative dietary factor for insulin resistance as well. If blueberry consumption both shifts metabolism away from insulin resistance and reduces DNA damage, it may be a useful tool to assist in understanding relationships between these two obesity-associated conditions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Insulin Resistance, DNA Damage
Keywords
insulin, diabetes, obesity, DNA damage, metabolic syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Blueberry Powder
Arm Type
Experimental
Arm Description
The intervention group will receive the Blueberry freeze-dried powder equivalent to 1 cup of whole Blueberries twice a day for 8 weeks (i.e. 2 cups/day).
Arm Title
Placebo Powder
Arm Type
Placebo Comparator
Arm Description
The placebo group will receive placebo powder in the same amounts for the same duration.
Intervention Type
Dietary Supplement
Intervention Name(s)
Blueberry Powder
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
DNA damage in peripheral blood mononuclear cells
Description
DNA double-stranded breaks (DSBs) will be measured.
Time Frame
Baseline and 2 months
Secondary Outcome Measure Information:
Title
Insulin resistance
Description
Insulin resistance will be measured by a 2-hr glucose tolerance test.
Time Frame
Baseline and 2 months
Other Pre-specified Outcome Measures:
Title
Thiol/Redox changes
Description
Metabolomic profile measuring shifts in the plasma redox environment
Time Frame
Baseline and 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Age 30-60 years;
BMI > 30;
Blood pressure <140/90 mmHg without antihypertensive medicines or with a stable dose of antihypertensive medicines (no change in last 3 months).;
Insulin resistance (HOMA/IR) > 2.0;
Willing to restrict intake of high polyphenol-containing foods during the trial period;
Willing to forego intake of nutritional supplements other than a multivitamin;
Willing to maintain their current daily level of exercise throughout the study.
Exclusion criteria:
Known diabetes mellitus according to the 2013 ADA criteria;
Medications known to affect glucose metabolism;
Weight loss pharmacotherapy;
Lipid-lowering medication;
Untreated thyroid or chronic liver, renal, or cardiovascular disease;
Smoking;
Pregnancy- a negative urine pregnancy test will be documented for any women participants of childbearing age prior to enrollment.
History of allergic reactions to blueberries.
Any pathological condition known to alter white blood cell count over the previous 6 months;
Exposure to drugs known to cause mutations or radiation within the previous 6 months;
Alcohol consumption greater than 2 drinks/d for males and 1 drink/d for females.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Ames, PhD
Organizational Affiliation
Children's Hospital & Research Center at Oakland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ashutosh Lal, MD
Organizational Affiliation
Children's Hospital & Research Center at Oakland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital & Research Center Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
12. IPD Sharing Statement
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Effect of Blueberry Consumption on Metabolic Syndrome & DNA Damage
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