NCT01809795

Brief Summary

The purpose of this study to determine if adding blueberries to obese children's diet will improve weight status and other medical testing. We would also like to determine if a larger research study involving blueberries is possible.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Mar 2013

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

First Submitted

Initial submission to the registry

February 6, 2013

Completed
23 days until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 13, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 18, 2014

Status Verified

December 1, 2014

Enrollment Period

7 months

First QC Date

February 6, 2013

Last Update Submit

December 16, 2014

Conditions

Obesity

Keywords

ObesityExerciseBlueberry Plant

Outcome Measures

Primary Outcomes (1)

  • Attendance and compliance to healthy eating plan, group exercise class and smoothie consumption will be measured to assess feasibility of larger, randomized study.

    12 weeks

Secondary Outcomes (5)

  • Vascular Function

    Baseline and after 12 week program

  • Graded Exercise Test

    Baseline and after 12 week program

  • Cognitive Function/Memory

    Baseline and after 12 week program

  • Anthropometric Measurements

    Baseline and after 12 week program

  • Laboratory Testing

    Baseline and after 12 week program

Study Arms (2)

Blueberry Smoothie

EXPERIMENTAL

Participants in this group will receive a smoothie containing 1 1/2 cups of freeze-dried whole blueberries crushed into a powder.

Other: Blueberry Smoothie

Sham Smoothie

SHAM COMPARATOR

Participants in this group will receive a smoothie that contains no blueberries.

Other: Sham Smoothie

Interventions

Blueberry SmoothieOTHER
Blueberry Smoothie
Sham SmoothieOTHER
Sham Smoothie

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children 12 to 17 years old at the time of enrollment
  • Children with a BMI ≥ 95th percentile for age
  • Children participating in a weight management program at the CBHN.

You may not qualify if:

  • Children/parents/guardians who appear unable to understand the study
  • Children/parents appear unable to meet the requirements of participating, specifically not missing more than 1 consecutive week during the 12 week intervention
  • Children who have a medical condition or development impairment that precludes them from participating in an exercise program
  • Children who have type 2 diabetes
  • Children who have been diagnosed with hypertension
  • Children who are taking a statin
  • Children who are pregnant or have given birth within 6 months
  • Children with a history of significant cardiac disease leading to cardiovascular instability
  • Children who have food allergies or are lactose intolerant
  • Children who are unable to finish at least half of the smoothie while they taste it after the consent/assent process or decide after tasting the smoothie that they are no longer interested in participating.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (17)

  • Ogden CL, Carroll MD, Curtin LR, Lamb MM, Flegal KM. Prevalence of high body mass index in US children and adolescents, 2007-2008. JAMA. 2010 Jan 20;303(3):242-9. doi: 10.1001/jama.2009.2012. Epub 2010 Jan 13.

    PMID: 20071470BACKGROUND

  • Freedman DS, Khan LK, Serdula MK, Dietz WH, Srinivasan SR, Berenson GS. The relation of childhood BMI to adult adiposity: the Bogalusa Heart Study. Pediatrics. 2005 Jan;115(1):22-7. doi: 10.1542/peds.2004-0220.

    PMID: 15629977BACKGROUND

  • Deckelbaum RJ, Williams CL. Childhood obesity: the health issue. Obes Res. 2001 Nov;9 Suppl 4:239S-243S. doi: 10.1038/oby.2001.125.

    PMID: 11707548BACKGROUND

  • Lampe JW. Health effects of vegetables and fruit: assessing mechanisms of action in human experimental studies. Am J Clin Nutr. 1999 Sep;70(3 Suppl):475S-490S. doi: 10.1093/ajcn/70.3.475s.

    PMID: 10479220BACKGROUND

  • Prior RL. Fruits and vegetables in the prevention of cellular oxidative damage. Am J Clin Nutr. 2003 Sep;78(3 Suppl):570S-578S. doi: 10.1093/ajcn/78.3.570S.

    PMID: 12936951BACKGROUND

  • Duffy KB, Spangler EL, Devan BD, Guo Z, Bowker JL, Janas AM, Hagepanos A, Minor RK, DeCabo R, Mouton PR, Shukitt-Hale B, Joseph JA, Ingram DK. A blueberry-enriched diet provides cellular protection against oxidative stress and reduces a kainate-induced learning impairment in rats. Neurobiol Aging. 2008 Nov;29(11):1680-9. doi: 10.1016/j.neurobiolaging.2007.04.002. Epub 2007 May 23.

    PMID: 17524525BACKGROUND

  • Wu X, Kang J, Xie C, Burris R, Ferguson ME, Badger TM, Nagarajan S. Dietary blueberries attenuate atherosclerosis in apolipoprotein E-deficient mice by upregulating antioxidant enzyme expression. J Nutr. 2010 Sep;140(9):1628-32. doi: 10.3945/jn.110.123927. Epub 2010 Jul 21.

    PMID: 20660283BACKGROUND

  • Wang YP, Cheng ML, Zhang BF, Mu M, Wu J. Effects of blueberry on hepatic fibrosis and transcription factor Nrf2 in rats. World J Gastroenterol. 2010 Jun 7;16(21):2657-63. doi: 10.3748/wjg.v16.i21.2657.

    PMID: 20518088BACKGROUND

  • Casadesus G, Shukitt-Hale B, Stellwagen HM, Zhu X, Lee HG, Smith MA, Joseph JA. Modulation of hippocampal plasticity and cognitive behavior by short-term blueberry supplementation in aged rats. Nutr Neurosci. 2004 Oct-Dec;7(5-6):309-16. doi: 10.1080/10284150400020482.

    PMID: 15682927BACKGROUND

  • Andres-Lacueva C, Shukitt-Hale B, Galli RL, Jauregui O, Lamuela-Raventos RM, Joseph JA. Anthocyanins in aged blueberry-fed rats are found centrally and may enhance memory. Nutr Neurosci. 2005 Apr;8(2):111-20. doi: 10.1080/10284150500078117.

    PMID: 16053243BACKGROUND

  • Elks CM, Reed SD, Mariappan N, Shukitt-Hale B, Joseph JA, Ingram DK, Francis J. A blueberry-enriched diet attenuates nephropathy in a rat model of hypertension via reduction in oxidative stress. PLoS One. 2011;6(9):e24028. doi: 10.1371/journal.pone.0024028. Epub 2011 Sep 15.

    PMID: 21949690BACKGROUND

  • Kay CD, Holub BJ. The effect of wild blueberry (Vaccinium angustifolium) consumption on postprandial serum antioxidant status in human subjects. Br J Nutr. 2002 Oct;88(4):389-98. doi: 10.1079/BJN2002665.

    PMID: 12323088BACKGROUND

  • Stull AJ, Cash KC, Johnson WD, Champagne CM, Cefalu WT. Bioactives in blueberries improve insulin sensitivity in obese, insulin-resistant men and women. J Nutr. 2010 Oct;140(10):1764-8. doi: 10.3945/jn.110.125336. Epub 2010 Aug 19.

    PMID: 20724487BACKGROUND

  • Krikorian R, Shidler MD, Nash TA, Kalt W, Vinqvist-Tymchuk MR, Shukitt-Hale B, Joseph JA. Blueberry supplementation improves memory in older adults. J Agric Food Chem. 2010 Apr 14;58(7):3996-4000. doi: 10.1021/jf9029332.

    PMID: 20047325BACKGROUND

  • Basu A, Du M, Leyva MJ, Sanchez K, Betts NM, Wu M, Aston CE, Lyons TJ. Blueberries decrease cardiovascular risk factors in obese men and women with metabolic syndrome. J Nutr. 2010 Sep;140(9):1582-7. doi: 10.3945/jn.110.124701. Epub 2010 Jul 21.

    PMID: 20660279BACKGROUND

  • Barlow SE; Expert Committee. Expert committee recommendations regarding the prevention, assessment, and treatment of child and adolescent overweight and obesity: summary report. Pediatrics. 2007 Dec;120 Suppl 4:S164-92. doi: 10.1542/peds.2007-2329C.

    PMID: 18055651BACKGROUND

  • Kirk S, Brehm B, Saelens BE, Woo JG, Kissel E, D'Alessio D, Bolling C, Daniels SR. Role of carbohydrate modification in weight management among obese children: a randomized clinical trial. J Pediatr. 2012 Aug;161(2):320-7.e1. doi: 10.1016/j.jpeds.2012.01.041. Epub 2012 Feb 28.

    PMID: 22381024BACKGROUND

MeSH Terms

Conditions

ObesityMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Robert Siegel, MD

    Children's Hospital Medical Center, Cincinnati

    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 6, 2013

First Posted

March 13, 2013

Study Start

March 1, 2013

Primary Completion

October 1, 2013

Study Completion

December 1, 2014

Last Updated

December 18, 2014

Record last verified: 2014-12

Locations

US(1)