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Completed

NCT Number: NCT02075307

Effect of Blueberry Consumption on Metabolic Syndrome & DNA Damage

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.

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Key information

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital & Research Center Oakland

Oakland, California, 94609, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blueberry powder

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. DNA damage in peripheral blood mononuclear cells

    Time frame: Baseline and 2 months

    DNA double-stranded breaks (DSBs) will be measured.

Secondary outcomes

  1. Insulin resistance

    Time frame: Baseline and 2 months

    Insulin resistance will be measured by a 2-hr glucose tolerance test.

Other outcomes

  1. Thiol/Redox changes

    Time frame: Baseline and 2 months

    Metabolomic profile measuring shifts in the plasma redox environment

Sponsors and collaborators

Lead sponsor

UCSF Benioff Children's Hospital Oakland

Other

Collaborators

  • U.S. Highbush Blueberry Council
  • USDA Agricultural Research Station in Albany, CA

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Mar 3, 2014
Registry last updated
Dec 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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