Effect of Blueberry Consumption on Metabolic Syndrome & DNA Damage

Sponsor

UCSF Benioff Children's Hospital Oakland (Other)

Overall Status

Completed

CT.gov ID

NCT02075307

Collaborator

U.S. Highbush Blueberry Council (Other), USDA Agricultural Research Station in Albany, CA (Other)

Enrollment

Location

Arms

39.1

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome Insulin Resistance DNA Damage	Dietary Supplement: Blueberry Powder Dietary Supplement: Placebo	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

7 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Apr 4, 2017

Actual Study Completion Date :

Apr 4, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Blueberry Powder 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).	Dietary Supplement: Blueberry Powder
Placebo Comparator: Placebo Powder The placebo group will receive placebo powder in the same amounts for the same duration.	Dietary Supplement: Placebo

Arm

Intervention/Treatment

Experimental: Blueberry Powder

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).

Dietary Supplement: Blueberry Powder

Placebo Comparator: Placebo Powder

The placebo group will receive placebo powder in the same amounts for the same duration.

Dietary Supplement: Placebo

Outcome Measures

Primary Outcome Measures

DNA damage in peripheral blood mononuclear cells [Baseline and 2 months]
DNA double-stranded breaks (DSBs) will be measured.

Secondary Outcome Measures

Insulin resistance [Baseline and 2 months]
Insulin resistance will be measured by a 2-hr glucose tolerance test.

Other Outcome Measures

Thiol/Redox changes [Baseline and 2 months]
Metabolomic profile measuring shifts in the plasma redox environment

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital & Research Center Oakland	Oakland	California	United States	94609

Sponsors and Collaborators

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

Investigators

Principal Investigator: Bruce Ames, PhD, Children's Hospital & Research Center at Oakland
Principal Investigator: Ashutosh Lal, MD, Children's Hospital & Research Center at Oakland