Hyper-LDL-cholesterolemiaNCT03441620
The Effects of Strawberries on Blood Cholesterol.
A study testing strawberries in people with Hyper-LDL-cholesterolemia and Metabolic Syndrome, run by University of Nevada, Las Vegas at 3 sites in United States.
Trial summary
In this study, we propose to investigate the effects of dietary achievable doses of strawberries on serum LDL-cholesterol (LDL-C) and related lipid profiles, measures of glycemia and insulin resistance, and biomarkers of inflammation in a 14 week controlled crossover study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hyper-LDL-cholesterolemia, Metabolic Syndrome
- What is being tested?
- strawberries
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Feb 2018to 31 Jan 2021
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elevated total and LDL cholesterol (>116 mg/dL)
- body mass index (> or = 30 kg/m2)
- features of the metabolic syndrome
Who cannot join
- taking glucose and lipid lowering medications (e.g. statins, metformin)
- history of chronic conditions (diabetes, CHD, anemia, renal diseases)
- allergic to strawberries
- pregnant and/or lactating
- smoking
- vegetarian or consuming special diet
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Nevada at Las Vegas
Las Vegas, Nevada, 89154
University of Oklahoma Health Sciences Center, OCTSI
Oklahoma City, Oklahoma, 73104
Oklahoma State University
Stillwater, Oklahoma, 74078
About this study
Official title: Effects of Strawberries on LDL Cholesterol and Insulin Resistance in Overweight/Obese Adults With the Metabolic Syndrome.
In this study, we propose to investigate the effects of dietary achievable doses of strawberries on serum LDL-cholesterol (LDL-C) and related lipid profiles, measures of glycemia and insulin resistance, and biomarkers of inflammation in a 14 week controlled crossover study.
Read the detailed description
The screen visit will involve an 8 hour fasting state and the following procedures:
- Completing screening questionnaire
- Measuring height, weight, blood pressure, and waist size
- Drawing about 30mL blood for blood glucose and lipids and comprehensive metabolic panel All subjects will be asked to follow usual diet and lifestyle, and refrain from other sources of berries and related products while on the study. Subjects will also maintain 3-day food records at screen, 4, 9, and 14 weeks of the study. Height, weight, blood pressure and waist circumference will be measured by trained personnel at MPE 326 (KNS facility for clinical research). Blood draws will be performed by trained phlebotomists (to be hired) at MPE 326, and all procedures will be performed by trained research personnel [PI \&Co-PI: Basu, Izuora and graduate student]. In case of blood pressure, an average of at least three readings, 10 min apart, will be measured at each visit for each participant. Blood glucose (fasting and postprandial at two hours) will be determined at each time point. The oral glucose tolerance tests will be conducted at MPE 326 and blood samples will be sent to Quest Diagnostics, Las Vegas. Insulin resistance will be calculated using the homoeostatic model assessment (HOMA-IR). The HOMA-IR is a standard and widely used formula in calculating insulin resistance based on fasting glucose values. Screening and follow-up tests will include clinical laboratory tests for blood glucose, lipids, NMR profiles, C-reactive protein and metabolic panel to determine effects of the intervention.
- Conditions
- Hyper-LDL-cholesterolemia, Metabolic Syndrome
- Being tested
- strawberries, Control powder
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
strawberriesDietary supplement
Freeze-dried strawberry powder
Control powderOther
Control powder matched for fiber and strawberries
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Calorie and fiber-matched control powder Receives: Other: Control powder |
| Strawberry one serving | Experimental | Freeze-dried powder equivalent to one serving fresh strawberries per day. Receives: Dietary Supplement: strawberries |
| Strawberry two-half servings | Experimental | Freeze-dried powder equivalent to 2.5 serving fresh strawberries per day. Receives: Dietary Supplement: strawberries |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Lipid profiles
Serum LDL, total and HDL cholesterol, triglycerides
Measured: 14 weeks
Glycemic control
Blood glucose
Measured: 14 weeks
Serum lipid particle concentrations
Molar concentrations of serum lipids and particle size
Measured: 14 weeks
Diabetes control
Insulin resistance
Measured: 14 weeks
Secondary outcomes (3)
Systemic Inflammation
Serum C-reactive protein and adipokines
Measured: 14 weeks
Systemic Anthocyanins
Strawberry anthocyanin metabolites measured in serum
Measured: 14 weeks
Serum metabolomics
primary and lipid metabolites in serum
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start1 Feb 2018
- Primary completion31 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyper-LDL-cholesterolemiaStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Las Vegas
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oklahoma, Oklahoma State University
- Responsible party
- Principal investigator, Arpita Basu, University of Nevada, Las Vegas
- Investigators
- Arpita Basu, PHD, Principal investigator, University of Nevada at Las Vegas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03441620
- Sponsor's protocol ID
- 1119274
- Status last verified
- Mar 2021
- First submitted
- 5 Feb 2018
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Strawberries on LDL Cholesterol and Insulin Resistance in Overweight/Obese Adults With the Metabolic Syndrome.
- ClinicalTrials.gov ID
- NCT03441620
- Acronym / sponsor ID
- 1119274
- Conditions
- Hyper-LDL-cholesterolemia, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Nevada, Las VegasUniversity, hospital or other
- Collaborators
- University of Oklahoma, Oklahoma State University
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 22 Feb 2018 (actual)
- 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.
In this study, we propose to investigate the effects of dietary achievable doses of strawberries on serum LDL-cholesterol (LDL-C) and related lipid profiles, measures of glycemia and insulin resistance, and biomarkers of inflammation in a 14 week controlled crossover study.
Detailed description
The screen visit will involve an 8 hour fasting state and the following procedures:
- Completing screening questionnaire
- Measuring height, weight, blood pressure, and waist size
- Drawing about 30mL blood for blood glucose and lipids and comprehensive metabolic panel All subjects will be asked to follow usual diet and lifestyle, and refrain from other sources of berries and related products while on the study. Subjects will also maintain 3-day food records at screen, 4, 9, and 14 weeks of the study. Height, weight, blood pressure and waist circumference will be measured by trained personnel at MPE 326 (KNS facility for clinical research). Blood draws will be performed by trained phlebotomists (to be hired) at MPE 326, and all procedures will be performed by trained research personnel [PI \&Co-PI: Basu, Izuora and graduate student]. In case of blood pressure, an average of at least three readings, 10 min apart, will be measured at each visit for each participant. Blood glucose (fasting and postprandial at two hours) will be determined at each time point. The oral glucose tolerance tests will be conducted at MPE 326 and blood samples will be sent to Quest Diagnostics, Las Vegas. Insulin resistance will be calculated using the homoeostatic model assessment (HOMA-IR). The HOMA-IR is a standard and widely used formula in calculating insulin resistance based on fasting glucose values. Screening and follow-up tests will include clinical laboratory tests for blood glucose, lipids, NMR profiles, C-reactive protein and metabolic panel to determine effects of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: Control powderCalorie and fiber-matched control powder |
| Strawberry one serving | Experimental | Dietary Supplement: strawberriesFreeze-dried powder equivalent to one serving fresh strawberries per day. |
| Strawberry two-half servings | Experimental | Dietary Supplement: strawberriesFreeze-dried powder equivalent to 2.5 serving fresh strawberries per day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- elevated total and LDL cholesterol (>116 mg/dL)
- body mass index (> or = 30 kg/m2)
- features of the metabolic syndrome
Key exclusion criteria (6 listed)
- taking glucose and lipid lowering medications (e.g. statins, metformin)
- history of chronic conditions (diabetes, CHD, anemia, renal diseases)
- allergic to strawberries
- pregnant and/or lactating
- smoking
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 |
|---|---|---|
| strawberriesFreeze-dried strawberry powder | Dietary supplement | Strawberry one serving, Strawberry two-half servings |
| Control powderControl powder matched for fiber and strawberries | Other | Control |
Primary outcome
Serum Lipid profiles
Time frame: 14 weeks
Serum LDL, total and HDL cholesterol, triglycerides
Glycemic control
Time frame: 14 weeks
Blood glucose
Serum lipid particle concentrations
Time frame: 14 weeks
Molar concentrations of serum lipids and particle size
Diabetes control
Time frame: 14 weeks
Insulin resistance
3 secondary outcomes
Systemic Inflammation
Time frame: 14 weeks
Systemic Anthocyanins
Time frame: 14 weeks
Serum metabolomics
Time frame: 14 weeks
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 16 Mar 2021.
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
University of Nevada at Las Vegas
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing strawberries in people with Hyper-LDL-cholesterolemia and Metabolic Syndrome, run by University of Nevada, Las Vegas at 3 sites 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 6 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 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Serum Lipid profiles (time frame: 14 weeks). The study lists 4 primary outcomes in all. 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 16 Mar 2021.