ObesityNCT04094103
Strawberry Consumption in Overweight and Obese Individuals
A study testing Active strawberry powder and Mixed strawberry powder in people with Obesity and Metabolic Syndrome, run by Carl Ade, M.S., Ph.D. at 1 site in United States.
Trial summary
Our proposal represents an integrated approach to determining the cardiovascular and metabolic effects of strawberry consumption in adults who have high risk for cardiometabolic disease. Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Metabolic Syndrome
- What is being tested?
- Active strawberry powder and Mixed strawberry powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 27 Oct 2023
- 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 35 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overweight or obese by BMI (25.0-34.9kg/m2),
- Borderline-high LDL-cholesterol (130-159mg/dL),
- Normal or elevated blood pressure ((≤129mmHg/≤80mmHg)
Who cannot join
- known allergy or intolerance to strawberries
- taking any medications for chronic diseases including anti-inflammatory, anti-hypertensive, lipid-lowering, glucose-controlling, or steroidal medications
- taking any supplements that might affect outcomes of the study including anti-oxidant or fish-oil supplements
- having anemia or any liver, thyroid, renal conditions
- current smoker or user of tobacco products, or use within the past three months
- consuming alcohol (>1-2 drinks/day) on a regular basis
Show all 11Show fewer
- currently pregnant or lactating
- having elevated blood pressure ≥130mmHg/≥80mmHg
- presence of diagnosed diabetes mellitus, inflammatory disease, atherosclerotic disease, or other relevant chronic conditions
- total cholesterol ≥240mg/dL
- hemoglobin normal range values for males (between 13.0-17.5g/dL) and females (between 12.5-15.5g/dL)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrated Cardiovascular and Metabolic Effects of Strawberry Consumption in Overweight and Obese Individuals
Our proposal represents an integrated approach to determining the cardiovascular and metabolic effects of strawberry consumption in adults who have high risk for cardiometabolic disease.
Read the detailed description
The current proposal aims to fill some of these important research gaps with regard the dose and time-course of strawberry consumption in a population where dietary intervention may of particular benefit for both primary and secondary prevention of cardiovascular and metabolic disease. Participants will participate in a double blind, placebo-controlled, randomized crossover trial. Following a 10-day run-in where no berries are consumed, participants will be randomized via Latin-square design, to three different daily strawberry powder conditions for 4-weeks at a time, with a 7 day washout between conditions.
- Conditions
- Obesity, Metabolic Syndrome
- Being tested
- Active strawberry powder, Placebo strawberry powder, Mixed strawberry powder
- Medical subject headings
- Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active strawberry powderDietary supplement
Participants will drink a strawberry beverage with active ingredients once a day during the 4-week intervention period.
Placebo strawberry powderDietary supplement
Participants will drink a strawberry placebo beverage once a day during the 4-week intervention period.
Mixed strawberry powderDietary supplement
Participants will drink a mixed strawberry beverage with active ingredients and placebo once a day during the 4-week intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Active strawberry powder | Experimental | Participants will consume a 39g freeze-dried active strawberry powder beverage once per day for 4-weeks. Receives: Dietary Supplement: Active strawberry powder |
| Placebo strawberry powder | Placebo comparator | Participants will consume a 39g freeze-dried strawberry powder placebo beverage once per day for 4-weeks. Receives: Dietary Supplement: Placebo strawberry powder |
| Mixed active/placebo strawberry powder | Active comparator | Participants will consume a 39g mixed active/placebo strawberry powder beverage once per day for 4-weeks. Receives: Dietary Supplement: Mixed strawberry powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma lipids
Total cholesterol (TC), LDL-c , VLDL-c, HDL-c , triglycerides (TG) from blood sample in a fasted state and following consumption of a meal
Measured: Week 0, 4, 5, 9, 10, and 14
Secondary outcomes (7)
Change in glucose and insulin response
Glucose, insulin, and c-peptide obtained from blood sample in a fasted state and in response to a meal
Measured: Week 0, 4, 5, 9, 10, and 14
Change in oxidixed LDL
Obtained from blood sample in a fasted state and following consumption of a meal
Measured: Week 0, 4, 5, 9, 10, and 14
Change in homeostatic model assessment for insulin resistance
Calculated from fasting glucose and insulin values
Measured: Week 0, 4, 5, 9, 10, and 14
Change in inflammation
hs-CRP and IL-6 will be assessed in the fasted state from plasma
Measured: Week 0, 4, 5, 9, 10, and 14
Change in arterial stiffness
Determined via changes in carotid artery stiffness calculated from simultaneous measurements of carotid artery diameter and pressure-waveforms
Measured: Week 0, 4, 5, 9, 10, and 14
Change in blood pressure (resting and 24-hr)
Evaluated via automated sphygmomanometer. 24-hr ambulatory blood pressure is taken at 20-30 minute intervals over a 24hr period while the individual goes about their normal activities and while sleeping.
Measured: Week 0, 4, 5, 9, 10, and 14
Change in endothelial function
Flow mediated dilation (FMD) assessed via a non-invasive 2D Doppler ultrasound following a 5-min period of arterial occlusion.
Measured: Week 0, 4, 5, 9, 10, and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start1 Oct 2019
- Primary completion27 Oct 2023
- Study completion27 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carl Ade, M.S., Ph.D.
- Sponsor type
- University, hospital or other
- Collaborators
- California Strawberry Commission
- Responsible party
- Sponsor-investigator, Carl Ade, M.S., Ph.D., Kansas State University
- Investigators
- Sara Rosenkranz, PhD, Principal investigator, Kansas State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094103
- Sponsor's protocol ID
- Pro9736
- Status last verified
- Aug 2025
- First submitted
- 13 Sep 2019
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Cardiovascular and Metabolic Effects of Strawberry Consumption in Overweight and Obese Individuals
- ClinicalTrials.gov ID
- NCT04094103
- Acronym / sponsor ID
- Pro9736
- Conditions
- Obesity, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Carl Ade, M.S., Ph.D.University, hospital or other
- Collaborators
- California Strawberry Commission
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 27 Oct 2023 (actual)
- Study completion
- 27 Oct 2023 (actual)
- First posted
- 18 Sep 2019 (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.
Our proposal represents an integrated approach to determining the cardiovascular and metabolic effects of strawberry consumption in adults who have high risk for cardiometabolic disease.
Detailed description
The current proposal aims to fill some of these important research gaps with regard the dose and time-course of strawberry consumption in a population where dietary intervention may of particular benefit for both primary and secondary prevention of cardiovascular and metabolic disease. Participants will participate in a double blind, placebo-controlled, randomized crossover trial. Following a 10-day run-in where no berries are consumed, participants will be randomized via Latin-square design, to three different daily strawberry powder conditions for 4-weeks at a time, with a 7 day washout between conditions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active strawberry powder | Experimental | Dietary Supplement: Active strawberry powderParticipants will consume a 39g freeze-dried active strawberry powder beverage once per day for 4-weeks. |
| Placebo strawberry powder | Placebo comparator | Dietary Supplement: Placebo strawberry powderParticipants will consume a 39g freeze-dried strawberry powder placebo beverage once per day for 4-weeks. |
| Mixed active/placebo strawberry powder | Active comparator | Dietary Supplement: Mixed strawberry powderParticipants will consume a 39g mixed active/placebo strawberry powder beverage once per day for 4-weeks. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Overweight or obese by BMI (25.0-34.9kg/m2),
- Borderline-high LDL-cholesterol (130-159mg/dL),
- Normal or elevated blood pressure ((≤129mmHg/≤80mmHg)
Key exclusion criteria (11 listed)
- known allergy or intolerance to strawberries
- taking any medications for chronic diseases including anti-inflammatory, anti-hypertensive, lipid-lowering, glucose-controlling, or steroidal medications
- taking any supplements that might affect outcomes of the study including anti-oxidant or fish-oil supplements
- having anemia or any liver, thyroid, renal conditions
- current smoker or user of tobacco products, or use within the past three 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 |
|---|---|---|
| Active strawberry powderParticipants will drink a strawberry beverage with active ingredients once a day during the 4-week intervention period. | Dietary supplement | Active strawberry powder |
| Placebo strawberry powderParticipants will drink a strawberry placebo beverage once a day during the 4-week intervention period. | Dietary supplement | Placebo strawberry powder |
| Mixed strawberry powderParticipants will drink a mixed strawberry beverage with active ingredients and placebo once a day during the 4-week intervention period. | Dietary supplement | Mixed active/placebo strawberry powder |
Primary outcome
Change in plasma lipids
Time frame: Week 0, 4, 5, 9, 10, and 14
Total cholesterol (TC), LDL-c , VLDL-c, HDL-c , triglycerides (TG) from blood sample in a fasted state and following consumption of a meal
7 secondary outcomes
Change in glucose and insulin response
Time frame: Week 0, 4, 5, 9, 10, and 14
Change in oxidixed LDL
Time frame: Week 0, 4, 5, 9, 10, and 14
Change in homeostatic model assessment for insulin resistance
Time frame: Week 0, 4, 5, 9, 10, and 14
Change in inflammation
Time frame: Week 0, 4, 5, 9, 10, and 14
Change in arterial stiffness
Time frame: Week 0, 4, 5, 9, 10, and 14
Change in blood pressure (resting and 24-hr)
Time frame: Week 0, 4, 5, 9, 10, and 14
Change in endothelial function
Time frame: Week 0, 4, 5, 9, 10, and 14
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 2 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Sara Rosenkranz, PhD principal investigator
Kansas 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 Active strawberry powder and Mixed strawberry powder in people with Obesity and Metabolic Syndrome, run by Carl Ade, M.S., Ph.D. 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 11 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 2 Sep 2025. 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?
Change in plasma lipids (time frame: Week 0, 4, 5, 9, 10, and 14). 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 2 Sep 2025.