PreDiabetesPhase 1NCT05362968
Strawberries and Risk of Diabetes in Adults
A Phase 1 study testing Freeze-dried strawberry powder in people with PreDiabetes and Metabolic Syndrome, run by University of Nevada, Las Vegas at 1 site in United States.
Trial summary
Strawberries can be categorized as a functional food based on results from several clinical trials in improving cardiometabolic health beyond providing nutrition. Recent studies identify the role of strawberries in improving insulin resistance and risks of type 2 diabetes which urgently warrants further investigation… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes, Metabolic Syndrome
- What is being tested?
- Freeze-dried strawberry powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to 3 Jun 2024
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Waist size greater than 40 inches in men or 35 inches in women
- Blood glucose greater than 100mg/dL but less than 126 mg/dL or glycated hemoglobin less than 6.5%
- Insulin resistance >1.0
- Not on diabetes medications
- Normal liver and kidney function tests
Who cannot join
- Allergy to strawberries
- Smoke or drink alcohol on a regular basis
- Pregnant or lactating
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nevada at Las Vegas
Las Vegas, Nevada, 89154
About this study
Strawberries can be categorized as a functional food based on results from several clinical trials in improving cardiometabolic health beyond providing nutrition. Recent studies identify the role of strawberries in improving insulin resistance and risks of type 2 diabetes which urgently warrants further investigation, keeping in view the huge public health burden of diabetes in the US. In this study, the investigators propose to investigate the effects of a dietary achievable dose of strawberries on glycemic control, insulin resistance, and HbA1c (primary variables) and biomarkers of inflammation and endothelial function in a 28- week controlled crossover study.
Read the detailed description
Strawberries are popularly consumed fruits in the US and are a rich source of several bioactive compounds with demonstrated health benefits in T2D and cardiovascular disease (CVD). Based on previously reported studies, strawberries have been shown to improve elevated lipid profiles/dyslipidemia, oxidative stress and inflammation in adults with the metabolic syndrome or prediabetes. In a recently reported study, strawberries at a dose of two-and-a-half servings per day for four weeks was shown to significantly reduce insulin resistance and serum adipokines in obese adults. These results conform to only a few reported trials using strawberries in adults with cardiometabolic risks. While these study findings are clinically meaningful, these warrant urgent investigation in trials of longer duration specifically targeting adults with impaired fasting glucose (vs. other features of the metabolic syndrome) as well as adults with diagnosed T2D with poor glycemic control despite taking medications. Furthermore, to the best of our knowledge, only one clinical trial has been reported on the role of strawberries in improving glycemic control, oxidative stress, and inflammation in adults with T2D. While these results are encouraging, they lack generalizability due to the short duration of the study (six weeks) that precludes accurate changes in glycated hemoglobin (HbA1c) as a stable biomarker of glucose control. Based on these gaps in the existing literature, the investigators will examine the effects of strawberry supplementation at a dose of 2.5 servings/day for 12 weeks on glycemic control and related cardiometabolic profiles in prediabetes in a randomized controlled crossover trial.
- Conditions
- PreDiabetes, Metabolic Syndrome
- Being tested
- Freeze-dried strawberry powder
- Medical subject headings
- Prediabetic State, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freeze-dried strawberry powderDrug
Also called Freeze-dried strawberries
Whole strawberries are freeze-dried to form a powder with improved shelf life that will be used in this research study. Strawberry powder will be provided by the California Strawberry Commission (Watsonville, CA)
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No intervention | Each participants on usual diet and lifestyle for 12 weeks |
| Strawberry intervention | Experimental | Each participants will consume freeze-dried strawberry powder (32g/day) for 12 weeks Receives: Drug: Freeze-dried strawberry powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control
Blood glucose, insulin, glycated hemoglobin
Measured: 12 weeks
Lipid control
Blood total and LDL cholesterol
Measured: 12 weeks
Secondary outcomes (3)
Inflammation
cytokines C-reactive protein adhesion molecules
Measured: 12 weeks
Diabetes risk hormones
adiponectin, leptin
Measured: 12 weeks
Oxidative stress
Serum measures of antioxidants
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start1 Jan 2023
- Primary completion31 May 2024
- Study completion3 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PreDiabetesStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Las Vegas
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oklahoma
- 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
- NCT05362968
- Sponsor's protocol ID
- UNLV-2021-252
- Status last verified
- May 2025
- First submitted
- 2 May 2022
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Basu A, Hooyman A, Groven S, DeVillez P, Scofield RH, Ebersole JL, Champion A, Izuora K. Strawberries Improve Insulin Resistance and Related Cardiometabolic Markers in Adults with Prediabetes: A Randomized Controlled Crossover Trial. J Nutr. 2025 Jun;155(6):1828-1838. doi: 10.1016/j.tjnut.2025.04.015. Epub 2025 Apr 16.
PubMed 40250566
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strawberries and Risk of Diabetes in Adults
- ClinicalTrials.gov ID
- NCT05362968
- Acronym / sponsor ID
- UNLV-2021-252
- Conditions
- PreDiabetes, Metabolic Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of Nevada, Las VegasUniversity, hospital or other
- Collaborators
- University of Oklahoma
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 3 Jun 2024 (actual)
- First posted
- 5 May 2022 (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.
Strawberries can be categorized as a functional food based on results from several clinical trials in improving cardiometabolic health beyond providing nutrition. Recent studies identify the role of strawberries in improving insulin resistance and risks of type 2 diabetes which urgently warrants further investigation, keeping in view the huge public health burden of diabetes in the US. In this study, the investigators propose to investigate the effects of a dietary achievable dose of strawberries on glycemic control, insulin resistance, and HbA1c (primary variables) and biomarkers of inflammation and endothelial function in a 28- week controlled crossover study.
Detailed description
Strawberries are popularly consumed fruits in the US and are a rich source of several bioactive compounds with demonstrated health benefits in T2D and cardiovascular disease (CVD). Based on previously reported studies, strawberries have been shown to improve elevated lipid profiles/dyslipidemia, oxidative stress and inflammation in adults with the metabolic syndrome or prediabetes. In a recently reported study, strawberries at a dose of two-and-a-half servings per day for four weeks was shown to significantly reduce insulin resistance and serum adipokines in obese adults. These results conform to only a few reported trials using strawberries in adults with cardiometabolic risks. While these study findings are clinically meaningful, these warrant urgent investigation in trials of longer duration specifically targeting adults with impaired fasting glucose (vs. other features of the metabolic syndrome) as well as adults with diagnosed T2D with poor glycemic control despite taking medications. Furthermore, to the best of our knowledge, only one clinical trial has been reported on the role of strawberries in improving glycemic control, oxidative stress, and inflammation in adults with T2D. While these results are encouraging, they lack generalizability due to the short duration of the study (six weeks) that precludes accurate changes in glycated hemoglobin (HbA1c) as a stable biomarker of glucose control. Based on these gaps in the existing literature, the investigators will examine the effects of strawberry supplementation at a dose of 2.5 servings/day for 12 weeks on glycemic control and related cardiometabolic profiles in prediabetes in a randomized controlled crossover trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –Each participants on usual diet and lifestyle for 12 weeks |
| Strawberry intervention | Experimental | Drug: Freeze-dried strawberry powderEach participants will consume freeze-dried strawberry powder (32g/day) for 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- At least 18 years of age
- Waist size greater than 40 inches in men or 35 inches in women
- Blood glucose greater than 100mg/dL but less than 126 mg/dL or glycated hemoglobin less than 6.5%
- Insulin resistance >1.0
- Not on diabetes medications
Key exclusion criteria (3 listed)
- Allergy to strawberries
- Smoke or drink alcohol on a regular basis
- Pregnant or lactating
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 strawberry powderAlso: Freeze-dried strawberriesWhole strawberries are freeze-dried to form a powder with improved shelf life that will be used in this research study. Strawberry powder will be provided by the California Strawberry Commission (Watsonville, CA) | Drug | Strawberry intervention |
Primary outcome
Glycemic control
Time frame: 12 weeks
Blood glucose, insulin, glycated hemoglobin
Lipid control
Time frame: 12 weeks
Blood total and LDL cholesterol
3 secondary outcomes
Inflammation
Time frame: 12 weeks
Diabetes risk hormones
Time frame: 12 weeks
Oxidative stress
Time frame: 12 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 18 May 2025.
- Derived from this study: PubMed 40250566Basu A, Hooyman A, Groven S, DeVillez P, Scofield RH, Ebersole JL, Champion A, Izuora K. Strawberries Improve Insulin Resistance and Related Cardiometabolic Markers in Adults with Prediabetes: A Randomized Controlled Crossover Trial. J Nutr. 2025 Jun;155(6):1828-1838. doi: 10.1016/j.tjnut.2025.04.015. Epub 2025 Apr 16.
- Individual participant dataSharing planned: No
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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
University of Nevada at Las Vegas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Freeze-dried strawberry powder in people with PreDiabetes and Metabolic Syndrome, run by University of Nevada, Las Vegas 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 6 inclusion and 3 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 May 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Glycemic control (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 NCT05362968, which also lists 1 linked publication.
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 May 2025.