ObesityWild BlueberryNCT01809795
The Health Effects of a Blueberry Enriched Diet on Obese Children
A study testing Blueberry Smoothie in people with Obesity, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Obesity
- What is being tested?
- Blueberry Smoothie
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: The Health Effects of a Blueberry Enriched Diet on Obese Children: A Feasibility Study
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.
Read the detailed description
Ten children aged 12 to 17 years of age who have a BMI > 95th percentile for age and who are patients of the Center for Better Health and Nutrition will be recruited for this 12 week study.
Group 1 (Standard Therapy): Participants will be asked not to consume berries during the study so as not to confound the effects of eating blueberries. They will, however, be encouraged to consume other fruits consistent with nutrition guidelines for the Healthy Eating Plan (HEP: reduced glycemic load diet).
Participants will be instructed and receive educational handout materials on implementing HEP. In addition participants will be introduced to the use of behavioral tools (e.g. goal setting, daily tracking when goals are met, and incentives provided by the family) to help them stay on track with HEP. Participants will be seen by the dietitian at monthly intervals consistent with programmatic standard of care to review adherence to HEP, use of behavioral tools, and change in weight status.
Participants will be encouraged to attend group exercise classes five days per week or a minimum of four days per week. At the end of each exercise session, participants will receive a "sham smoothie" which contains no blueberries. The children will be directly observed by a study worker when consuming the smoothies to ensure compliance and measure how much of the smoothie was consumed.
Group 2 (Blueberry Enhanced): All the features of Group 1 with the exception that the participants will be given a smoothie that contain 1 1/2 cups of freeze-dried whole blueberries crushed into a powder per serving.
- Conditions
- Obesity
- Being tested
- Blueberry Smoothie, Sham Smoothie
- Keywords
- Obesity, Exercise, Blueberry Plant
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blueberry SmoothieOther
Sham SmoothieOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Blueberry Smoothie |
| Sham Smoothie | Sham comparator | Participants in this group will receive a smoothie that contains no blueberries. Receives: Other: Sham Smoothie |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attendance and compliance to healthy eating plan, group exercise class and smoothie consumption will be measured to assess feasibility of larger, randomized study.
Measured: 12 weeks
Secondary outcomes (5)
Vascular Function
Vascular Function Testing: augmentation index, Brachial Arterial Distensibility, Pulse Wave Velocity, EndoPAT, Laser Flow Doppler, Ultrasound Brachial Flow Mediated Dilation.
Measured: Baseline and after 12 week program
Graded Exercise Test
Exercise data: graded exercise test with submaximal VO2 measure at 6 and 9 minutes, VO2 max values.
Measured: Baseline and after 12 week program
Cognitive Function/Memory
Cognitive Function/Memory-CVLT and D-KFES at the initial medical evaluation and the WRAMIL 2-D-KFES Alternative Version at the final medical evaluation.
Measured: Baseline and after 12 week program
Anthropometric Measurements
Anthropometrics and clinical measurements: height, weight, BMI, BMI percentile, waist circumference, blood pressure, percent body fat by bioimpedance.
Measured: Baseline and after 12 week program
Laboratory Testing
Laboratory testing: fasting blood sugar, insulin, HDL, LDL, Total Cholesterol, Triglycerides, HgA1C, AST, ALT, GGT for research purposes.
Measured: Baseline and after 12 week program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionOct 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Pennington Biomedical Research Center
- Responsible party
- Sponsor
- Investigators
- Robert Siegel, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01809795
- Sponsor's protocol ID
- 2012-4400
- Acronym
- Wild Blueberry
- Status last verified
- Dec 2014
- First submitted
- 6 Feb 2013
- Last updated
- 18 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20071470Freedman 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.
PubMed 15629977Deckelbaum RJ, Williams CL. Childhood obesity: the health issue. Obes Res. 2001 Nov;9 Suppl 4:239S-243S. doi: 10.1038/oby.2001.125.
PubMed 11707548Lampe 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.
PubMed 10479220Prior 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.
PubMed 12936951Duffy 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.
PubMed 17524525Wu 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.
PubMed 20660283Wang 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.
PubMed 20518088Casadesus 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.
PubMed 15682927Andres-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.
PubMed 16053243Elks 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.
PubMed 21949690Kay 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.
PubMed 12323088Stull 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.
PubMed 20724487Krikorian 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.
PubMed 20047325Basu 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.
PubMed 20660279
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Health Effects of a Blueberry Enriched Diet on Obese Children: A Feasibility Study
- ClinicalTrials.gov ID
- NCT01809795
- Acronym / sponsor ID
- Wild Blueberry / 2012-4400
- Conditions
- Obesity
- Keywords
- Obesity, Exercise, Blueberry Plant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Pennington Biomedical Research Center
- Study start
- Mar 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Ten children aged 12 to 17 years of age who have a BMI > 95th percentile for age and who are patients of the Center for Better Health and Nutrition will be recruited for this 12 week study.
Group 1 (Standard Therapy): Participants will be asked not to consume berries during the study so as not to confound the effects of eating blueberries. They will, however, be encouraged to consume other fruits consistent with nutrition guidelines for the Healthy Eating Plan (HEP: reduced glycemic load diet).
Participants will be instructed and receive educational handout materials on implementing HEP. In addition participants will be introduced to the use of behavioral tools (e.g. goal setting, daily tracking when goals are met, and incentives provided by the family) to help them stay on track with HEP. Participants will be seen by the dietitian at monthly intervals consistent with programmatic standard of care to review adherence to HEP, use of behavioral tools, and change in weight status.
Participants will be encouraged to attend group exercise classes five days per week or a minimum of four days per week. At the end of each exercise session, participants will receive a "sham smoothie" which contains no blueberries. The children will be directly observed by a study worker when consuming the smoothies to ensure compliance and measure how much of the smoothie was consumed.
Group 2 (Blueberry Enhanced): All the features of Group 1 with the exception that the participants will be given a smoothie that contain 1 1/2 cups of freeze-dried whole blueberries crushed into a powder per serving.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blueberry Smoothie | Experimental | Other: Blueberry SmoothieParticipants in this group will receive a smoothie containing 1 1/2 cups of freeze-dried whole blueberries crushed into a powder. |
| Sham Smoothie | Sham comparator | Other: Sham SmoothieParticipants in this group will receive a smoothie that contains no blueberries. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blueberry Smoothie | Other | Blueberry Smoothie |
| Sham Smoothie | Other | Sham Smoothie |
Primary outcome
Attendance and compliance to healthy eating plan, group exercise class and smoothie consumption will be measured to assess feasibility of larger, randomized study.
Time frame: 12 weeks
5 secondary outcomes
Vascular Function
Time frame: Baseline and after 12 week program
Graded Exercise Test
Time frame: Baseline and after 12 week program
Cognitive Function/Memory
Time frame: Baseline and after 12 week program
Anthropometric Measurements
Time frame: Baseline and after 12 week program
Laboratory Testing
Time frame: Baseline and after 12 week program
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2014.
- Background: PubMed 20071470Ogden 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.
- Background: PubMed 15629977Freedman 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.
- Background: PubMed 11707548Deckelbaum RJ, Williams CL. Childhood obesity: the health issue. Obes Res. 2001 Nov;9 Suppl 4:239S-243S. doi: 10.1038/oby.2001.125.
- Background: PubMed 10479220Lampe 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.
- Background: PubMed 12936951Prior 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.
- Background: PubMed 17524525Duffy 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.
- Background: PubMed 20660283Wu 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.
- Background: PubMed 20518088Wang 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.
- Background: PubMed 15682927Casadesus 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.
- Background: PubMed 16053243Andres-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.
- Background: PubMed 21949690Elks 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.
- Background: PubMed 12323088Kay 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Siegel, MD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blueberry Smoothie in people with Obesity, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attendance and compliance to healthy eating plan, group exercise class and smoothie consumption will be measured to assess feasibility of larger, randomized study. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01809795, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2014.