DyslipidemiaNCT01883401
Chronic Effects of Freeze-Dried Strawberry Beverage on Cardiovascular Risk Factors
A study testing Freeze-dried strawberries and Dietary fiber in people with Dyslipidemia and Obesity, run by Oklahoma State University at 1 site in United States.
Trial summary
Berry anthocyanins have been shown to improve lipid profile in subjects with dyslipidemia while no such studies with whole strawberries have been reported in the US population. The investigators propose to examine the effects of low and high doses of freeze-dried strawberries on serum glucose, insulin, and lipid… Read more about this study
- Who is it for?
- Ages 19 to 72 years
- Conditions the study is for
- Dyslipidemia, Obesity
- What is being tested?
- Freeze-dried strawberries and Dietary fiber
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Mar 2013
- 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 19 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- dyslipidemia
- abdominal adiposity (>35 inches for women, >40 inches for men)
Who cannot join
- on statin therapy
- taking hypoglycemic agents
Trial locations and contacts
1 site in 1 country.
United States1 site
Oklahoma State University
Stillwater, Oklahoma, 74078
About this study
Official title: Chronic Effects of Freeze-dried Strawberry Beverage on Cardiovascular Risk Factors in Subjects With Abdominal Adiposity and Dyslipidemia.
Berry anthocyanins have been shown to improve lipid profile in subjects with dyslipidemia while no such studies with whole strawberries have been reported in the US population. The investigators propose to examine the effects of low and high doses of freeze-dried strawberries on serum glucose, insulin, and lipid profile, biomarkers of oxidative stress and inflammation, in a 12-week randomized controlled trial. Subjects with abdominal adiposity and dyslipidemia (n=15/group) will be recruited at OUHSC and OSU, and randomly assigned to the low (25g/day) or high (50g/day) strawberry dose, or matched control (fiber and calories) group. The strawberry group will consume freeze-dried strawberry beverage (2 cups/day) and the controls will consume 2 cups beverage (fiber +calories) daily for 12 weeks. Blood draws, anthropometrics, blood pressure, and dietary data will be collected at screen, 6 and 12 weeks of the study to determine chronic and acute effects of strawberry intervention. Serum or plasma samples will be analyzed for fasting glucose, insulin, lipid profile including total cholesterol, LDL-, and HDL-cholesterol, triglycerides, lipid particle size, and levels of oxidative stress (malondialdehyde, oxidized LDL, myeloperoxidase), inflammation (high sensitivity C-reactive protein, adiponectin, interleukins) and adhesion molecules. Repeated measures ANOVA will be performed using a 5% significance level. We anticipate a dose response effect in decrease in lipids, oxidative stress or inflammation following strawberry intervention versus controls.
Read the detailed description
The overall objective of this clinical trial is to investigate the effects of low and high doses of freeze-dried strawberries in cardiovascular risk factors in subjects with abdominal adiposity and dyslipidemia versus age and gender-matched controls.
- Conditions
- Dyslipidemia, Obesity
- Being tested
- Freeze-dried strawberries, Dietary fiber
- Keywords
- Strawberries, Heart health, Anthocyanins
- Medical subject headings
- Dyslipidemias, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freeze-dried strawberriesDietary supplement
25g or 50g freeze-dried strawberries reconstituted in water
Dietary fiberDietary supplement
4g or 8g dietary fiber blended in water
| Study group | Role | What they receive |
|---|---|---|
| High dose strawberry | Experimental | 50g freeze-dried strawberries/day Receives: Dietary Supplement: Freeze-dried strawberries |
| Low-dose strawberry | Experimental | 25g freeze-dried strawberries/day Receives: Dietary Supplement: Freeze-dried strawberries |
| Fiber/calorie control (high dose) | Other | Dietary fiber (8g) Receives: Dietary Supplement: Dietary fiber |
| Fiber/calorie control (low dose) | Other | Dietary fiber (4g) Receives: Dietary Supplement: Dietary fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipids (mg/dL)
Change in lipids and lipoproteins at screen and 12 weeks of the study
Measured: 2.5 years
Secondary outcomes (1)
Adhesion molecules (ng/mL)
Change in serum adhesion molecules (ICAM, VCAM) at screen and 12 weeks of the study.
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startApr 2010
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oklahoma State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oklahoma, California Strawberry Commission
- Responsible party
- Principal investigator, Arpita Basu, Oklahoma State University
- Investigators
- Arpita Basu, Phd, Principal investigator, Oklahoma State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883401
- Sponsor's protocol ID
- HE1015
- Status last verified
- Jun 2013
- First submitted
- 13 May 2013
- Last updated
- 21 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Basu A, Fu DX, Wilkinson M, Simmons B, Wu M, Betts NM, Du M, Lyons TJ. Strawberries decrease atherosclerotic markers in subjects with metabolic syndrome. Nutr Res. 2010 Jul;30(7):462-9. doi: 10.1016/j.nutres.2010.06.016.
PubMed 20797478Basu A, Betts NM, Nguyen A, Newman ED, Fu D, Lyons TJ. Freeze-dried strawberries lower serum cholesterol and lipid peroxidation in adults with abdominal adiposity and elevated serum lipids. J Nutr. 2014 Jun;144(6):830-7. doi: 10.3945/jn.113.188169. Epub 2014 Mar 26.
PubMed 24670970
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Effects of Freeze-dried Strawberry Beverage on Cardiovascular Risk Factors in Subjects With Abdominal Adiposity and Dyslipidemia.
- ClinicalTrials.gov ID
- NCT01883401
- Acronym / sponsor ID
- HE1015
- Conditions
- Dyslipidemia, Obesity
- Keywords
- Strawberries, Heart health, Anthocyanins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Oklahoma State UniversityUniversity, hospital or other
- Collaborators
- University of Oklahoma, California Strawberry Commission
- Study start
- Apr 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 21 Jun 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.
Berry anthocyanins have been shown to improve lipid profile in subjects with dyslipidemia while no such studies with whole strawberries have been reported in the US population. The investigators propose to examine the effects of low and high doses of freeze-dried strawberries on serum glucose, insulin, and lipid profile, biomarkers of oxidative stress and inflammation, in a 12-week randomized controlled trial. Subjects with abdominal adiposity and dyslipidemia (n=15/group) will be recruited at OUHSC and OSU, and randomly assigned to the low (25g/day) or high (50g/day) strawberry dose, or matched control (fiber and calories) group. The strawberry group will consume freeze-dried strawberry beverage (2 cups/day) and the controls will consume 2 cups beverage (fiber +calories) daily for 12 weeks. Blood draws, anthropometrics, blood pressure, and dietary data will be collected at screen, 6 and 12 weeks of the study to determine chronic and acute effects of strawberry intervention. Serum or plasma samples will be analyzed for fasting glucose, insulin, lipid profile including total cholesterol, LDL-, and HDL-cholesterol, triglycerides, lipid particle size, and levels of oxidative stress (malondialdehyde, oxidized LDL, myeloperoxidase), inflammation (high sensitivity C-reactive protein, adiponectin, interleukins) and adhesion molecules. Repeated measures ANOVA will be performed using a 5% significance level. We anticipate a dose response effect in decrease in lipids, oxidative stress or inflammation following strawberry intervention versus controls.
Detailed description
The overall objective of this clinical trial is to investigate the effects of low and high doses of freeze-dried strawberries in cardiovascular risk factors in subjects with abdominal adiposity and dyslipidemia versus age and gender-matched controls.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High dose strawberry | Experimental | Dietary Supplement: Freeze-dried strawberries50g freeze-dried strawberries/day |
| Low-dose strawberry | Experimental | Dietary Supplement: Freeze-dried strawberries25g freeze-dried strawberries/day |
| Fiber/calorie control (high dose) | Other | Dietary Supplement: Dietary fiberDietary fiber (8g) |
| Fiber/calorie control (low dose) | Other | Dietary Supplement: Dietary fiberDietary fiber (4g) |
Who may qualify
- Ages
- 19 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- dyslipidemia
- abdominal adiposity (>35 inches for women, >40 inches for men)
Key exclusion criteria (2 listed)
- on statin therapy
- taking hypoglycemic agents
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 |
|---|---|---|
| Freeze-dried strawberries25g or 50g freeze-dried strawberries reconstituted in water | Dietary supplement | High dose strawberry, Low-dose strawberry |
| Dietary fiber4g or 8g dietary fiber blended in water | Dietary supplement | Fiber/calorie control (high dose), Fiber/calorie control (low dose) |
Primary outcome
Lipids (mg/dL)
Time frame: 2.5 years
Change in lipids and lipoproteins at screen and 12 weeks of the study
1 secondary outcome
Adhesion molecules (ng/mL)
Time frame: 2.5 years
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 21 Jun 2013.
- Background: PubMed 20797478Basu A, Fu DX, Wilkinson M, Simmons B, Wu M, Betts NM, Du M, Lyons TJ. Strawberries decrease atherosclerotic markers in subjects with metabolic syndrome. Nutr Res. 2010 Jul;30(7):462-9. doi: 10.1016/j.nutres.2010.06.016.
- Derived from this study: PubMed 24670970Basu A, Betts NM, Nguyen A, Newman ED, Fu D, Lyons TJ. Freeze-dried strawberries lower serum cholesterol and lipid peroxidation in adults with abdominal adiposity and elevated serum lipids. J Nutr. 2014 Jun;144(6):830-7. doi: 10.3945/jn.113.188169. Epub 2014 Mar 26.
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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.
Arpita Basu, Phd principal investigator
Oklahoma State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Freeze-dried strawberries and Dietary fiber in people with Dyslipidemia and Obesity, run by Oklahoma State University 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 2 inclusion and 2 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 21 Jun 2013. 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. 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?
Lipids (mg/dL) (time frame: 2.5 years). 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 NCT01883401, which also lists 2 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 21 Jun 2013.