Childhood ObesityPhase 2NCT01705093
The Effects of California Strawberries on Parameters of Cardiovascular Health
A Phase 2 study testing flavonoid-rich freeze-dried strawberry powder in people with Childhood Obesity and Cardiovascular Disease, run by University of California, Davis at 1 site in United States.
Trial summary
The prevalence of childhood obesity has been increasing over the past couple of decades. Similar to adults, overweight and obesity in young children and adolescents is associated with an increased number of cardiovascular risk factors including dyslipidemia, hypertension, insulin resistance and Type 2 diabetes. Read more about this study
- Who is it for?
- Ages 14 to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity, Cardiovascular Disease
- What is being tested?
- flavonoid-rich freeze-dried strawberry powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Jan 2015
- Phase
- Phase 2
- 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 14 to 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Male subjects, age 14 - 18 years.
- BMI for age and gender >75th percentile (based on CDC growth charts)
- Subject is willing and able to comply with the study protocols.
Who cannot join
- Inability to wear PAT probes
- Inability to remain still and remain quiet during test procedures
- BMI for age and gender ≤ 75th percentile (based on CDC growth charts)
- The use of medications that affect vascular function
- Regular use of dietary supplements during the last 6 months
- Blood pressure for age, gender and height ≥95th percentile
Show all 17Show fewer
- Chronic/routine high intensity exercise or current participation in a sports program
- Self/Parent reported use of anticoagulation agents including NSAIDs
- Self/Parent reported use of oral cortisone or other immunosuppressive agents,
- Self/Parent reported underlying neoplasia or immunological disease
- Self/Parent reported diabetes
- Food faddists or those taking a non-traditional diet
- Allergies to fruit
- Abnormal Liver, CBC or Chemistry panels (laboratory values outside the reference
- range) if determined to be clinically significant by the study physician.
- Self/Parent reported malabsorption (e.g. difficulty digesting or absorbing nutrients from food, potentially leading to bloating, cramping or gas).
- Asthma (can be worsened by mild to moderate food allergies).
Trial locations and contacts
1 site in 1 country.
United States1 site
Ragle Human Nutrition Research Center, Academic Surge, UC Davis
Davis, California, 95616
About this study
The prevalence of childhood obesity has been increasing over the past couple of decades. Similar to adults, overweight and obesity in young children and adolescents is associated with an increased number of cardiovascular risk factors including dyslipidemia, hypertension, insulin resistance and Type 2 diabetes. Epidemiological and clinical studies suggest that foods and ingredients rich in select flavonoids, such as cocoa, red grape products, tea, citrus fruits, and strawberries are protective against the development of cardiovascular disease. Strawberries are rich in flavonoids, particularly anthocyanins, flavanols, flavonols, ellagic acid and its glucose ester, ellagitanin. A number of in vitro studies have observed that these isolated compounds, as well as strawberry extracts have the potential to affect outcomes of cardiovascular health, including vascular reactivity, cellular signaling and oxidant defense6,7. We hypothesize that strawberry intake will lead to improvements in select measures of cardiovascular function in overweight and obese adolescent males.
- Conditions
- Childhood Obesity, Cardiovascular Disease
- Being tested
- flavonoid-rich freeze-dried strawberry powder, macronutrient-matched control powder
- Keywords
- strawberry, cardiovascular, obesity, adolescent
- Medical subject headings
- Pediatric Obesity, Cardiovascular Diseases, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flavonoid-rich freeze-dried strawberry powderDietary supplement
50g of flavonoid-rich freeze-dried strawberry powder
macronutrient-matched control powderDietary supplement
50g macronutrient-matched powder that will lack strawberry flavonoids
| Study group | Role | What they receive |
|---|---|---|
| Flavonoid-rich freeze-dried strawberry powder | Experimental | 50g of flavonoid-rich freeze-dried strawberry powder Receives: Dietary Supplement: flavonoid-rich freeze-dried strawberry powder |
| macronutrient- matched control powder | Placebo comparator | 50g macronutrient-matched control powder that will lack strawberry flavonoids Receives: Dietary Supplement: macronutrient-matched control powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular function measured by peripheral arterial tonometry
Change from baseline at 1 hour and 1 week post consumption of freeze-dried strawberry powder or control powder
Measured: Change from baseline in vascular function at 1 hour and 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2012 (estimated)
- Study startMay 2012
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01705093
- Sponsor's protocol ID
- 333071
- Status last verified
- Jul 2017
- First submitted
- 31 Aug 2012
- Last updated
- 14 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of California Strawberries on Parameters of Cardiovascular Health
- ClinicalTrials.gov ID
- NCT01705093
- Acronym / sponsor ID
- 333071
- Conditions
- Childhood Obesity, Cardiovascular Disease
- Keywords
- strawberry, cardiovascular, obesity, adolescent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- May 2012 (actual)
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 12 Oct 2012 (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 prevalence of childhood obesity has been increasing over the past couple of decades. Similar to adults, overweight and obesity in young children and adolescents is associated with an increased number of cardiovascular risk factors including dyslipidemia, hypertension, insulin resistance and Type 2 diabetes. Epidemiological and clinical studies suggest that foods and ingredients rich in select flavonoids, such as cocoa, red grape products, tea, citrus fruits, and strawberries are protective against the development of cardiovascular disease. Strawberries are rich in flavonoids, particularly anthocyanins, flavanols, flavonols, ellagic acid and its glucose ester, ellagitanin. A number of in vitro studies have observed that these isolated compounds, as well as strawberry extracts have the potential to affect outcomes of cardiovascular health, including vascular reactivity, cellular signaling and oxidant defense6,7. We hypothesize that strawberry intake will lead to improvements in select measures of cardiovascular function in overweight and obese adolescent males.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flavonoid-rich freeze-dried strawberry powder | Experimental | Dietary Supplement: flavonoid-rich freeze-dried strawberry powder50g of flavonoid-rich freeze-dried strawberry powder |
| macronutrient- matched control powder | Placebo comparator | Dietary Supplement: macronutrient-matched control powder50g macronutrient-matched control powder that will lack strawberry flavonoids |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Male subjects, age 14 - 18 years.
- BMI for age and gender >75th percentile (based on CDC growth charts)
- Subject is willing and able to comply with the study protocols.
Key exclusion criteria (17 listed)
- Inability to wear PAT probes
- Inability to remain still and remain quiet during test procedures
- BMI for age and gender ≤ 75th percentile (based on CDC growth charts)
- The use of medications that affect vascular function
- Regular use of dietary supplements during the last 6 months
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 |
|---|---|---|
| flavonoid-rich freeze-dried strawberry powder50g of flavonoid-rich freeze-dried strawberry powder | Dietary supplement | Flavonoid-rich freeze-dried strawberry powder |
| macronutrient-matched control powder50g macronutrient-matched powder that will lack strawberry flavonoids | Dietary supplement | macronutrient- matched control powder |
Primary outcome
Vascular function measured by peripheral arterial tonometry
Time frame: Change from baseline in vascular function at 1 hour and 1 week
Change from baseline at 1 hour and 1 week post consumption of freeze-dried strawberry powder or control powder
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 14 Jul 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing flavonoid-rich freeze-dried strawberry powder in people with Childhood Obesity and Cardiovascular Disease, run by University of California, Davis 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 17 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 14 Jul 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Vascular function measured by peripheral arterial tonometry (time frame: Change from baseline in vascular function at 1 hour and 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2017.