NCT02075307

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 3, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2017

Completed
Last Updated

December 23, 2020

Status Verified

December 1, 2020

Enrollment Period

3.3 years

First QC Date

February 27, 2014

Last Update Submit

December 22, 2020

Conditions

Metabolic SyndromeInsulin ResistanceDNA Damage

Keywords

insulindiabetesobesityDNA damagemetabolic syndrome

Outcome Measures

Primary Outcomes (1)

  • DNA damage in peripheral blood mononuclear cells

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

    Baseline and 2 months

Secondary Outcomes (1)

  • Insulin resistance

    Baseline and 2 months

Other Outcomes (1)

  • Thiol/Redox changes

    Baseline and 2 months

Study Arms (2)

Blueberry Powder

EXPERIMENTAL

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 Powder

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Blueberry PowderDIETARY_SUPPLEMENT
Blueberry Powder
PlaceboDIETARY_SUPPLEMENT
Placebo Powder

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital & Research Center Oakland

Oakland, California, 94609, United States

Location

MeSH Terms

Conditions

Metabolic SyndromeInsulin ResistanceDiabetes MellitusObesity

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bruce Ames, PhD

    Children's Hospital & Research Center at Oakland

    PRINCIPAL INVESTIGATOR

  • Ashutosh Lal, MD

    Children's Hospital & Research Center at Oakland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2014

First Posted

March 3, 2014

Study Start

January 1, 2014

Primary Completion

April 4, 2017

Study Completion

April 4, 2017

Last Updated

December 23, 2020

Record last verified: 2020-12

Locations

US(1)