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Effect of Blueberry Consumption on Metabolic Syndrome & DNA Damage

Highbush Blueberries, the DNA-damage of Obesity, Somatic Mutations and Metabolic Syndrome

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02075307
Enrollment
7
Registered
2014-03-03
Start date
2014-01-31
Completion date
2017-04-04
Last updated
2020-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

DNA Damage, Insulin Resistance, Metabolic Syndrome

Keywords

insulin, diabetes, obesity, DNA damage, metabolic syndrome

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.

Interventions

DIETARY_SUPPLEMENTBlueberry Powder
DIETARY_SUPPLEMENTPlacebo

Sponsors

U.S. Highbush Blueberry Council
CollaboratorOTHER
USDA Agricultural Research Station in Albany, CA
CollaboratorUNKNOWN
UCSF Benioff Children's Hospital Oakland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

1. Age 30-60 years; 2. BMI \> 30; 3. Blood pressure \<140/90 mmHg without antihypertensive medicines or with a stable dose of antihypertensive medicines (no change in last 3 months).; 4. Insulin resistance (HOMA/IR) \> 2.0; 5. Willing to restrict intake of high polyphenol-containing foods during the trial period; 6. Willing to forego intake of nutritional supplements other than a multivitamin; 7. Willing to maintain their current daily level of exercise throughout the study.

Exclusion criteria

1. Known diabetes mellitus according to the 2013 ADA criteria; 2. Medications known to affect glucose metabolism; 3. Weight loss pharmacotherapy; 4. Lipid-lowering medication; 5. Untreated thyroid or chronic liver, renal, or cardiovascular disease; 6. Smoking; 7. Pregnancy- a negative urine pregnancy test will be documented for any women participants of childbearing age prior to enrollment. 8. History of allergic reactions to blueberries. 9. Any pathological condition known to alter white blood cell count over the previous 6 months; 10. Exposure to drugs known to cause mutations or radiation within the previous 6 months; 11. Alcohol consumption greater than 2 drinks/d for males and 1 drink/d for females.

Design outcomes

Primary

MeasureTime frameDescription
DNA damage in peripheral blood mononuclear cellsBaseline and 2 monthsDNA double-stranded breaks (DSBs) will be measured.

Secondary

MeasureTime frameDescription
Insulin resistanceBaseline and 2 monthsInsulin resistance will be measured by a 2-hr glucose tolerance test.

Other

MeasureTime frameDescription
Thiol/Redox changesBaseline and 2 monthsMetabolomic profile measuring shifts in the plasma redox environment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026