Effect of Blueberry Consumption on Metabolic Syndrome & DNA Damage

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02075307
• Other study ID #: 2012-033
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: April 4, 2017

Study information

• Verified date: December 2020
• Source: UCSF Benioff Children's Hospital Oakland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: April 4, 2017
• Est. primary completion date: April 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• DNA Damage
• Insulin Resistance
• Metabolic Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Blueberry Powder

• Placebo

Locations

Country	Name	City	State
United States	Children's Hospital & Research Center Oakland	Oakland	California

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Thiol/Redox changes	Metabolomic profile measuring shifts in the plasma redox environment	Baseline and 2 months
Primary	DNA damage in peripheral blood mononuclear cells	DNA double-stranded breaks (DSBs) will be measured.	Baseline and 2 months
Secondary	Insulin resistance	Insulin resistance will be measured by a 2-hr glucose tolerance test.	Baseline and 2 months