Vascular DilationNCT04763499
The Influence of Daily Strawberry Intake on Vascular Health in Elderly Men
A study testing freeze dried strawberry powder in people with Vascular Dilation, run by University of California, Davis at 1 site in United States.
Trial summary
The overall objective of this proposed trial is to examine the vascular protective effects provided by the daily consumption of 39g of freeze dried strawberry powder (FDSP) for four weeks. The study population will be older men (60-80 years of age). Read more about this study
- Who is it for?
- Ages 60 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Vascular Dilation
- What is being tested?
- freeze dried strawberry powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2021to 31 Dec 2022
- 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 60 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is willing and able to comply with the study protocols.
- Subject is willing to participate in all study procedures
- BMI 25.0 - 35 kg/m2
Who cannot join
- BMI ≥ 35 kg/m2
- Visit 1 Reactive Hyperemia Index (RHI; EndoPAT 2000) ≥ 2.8
- Dislike or allergy strawberries
- Self-reported use of daily anticoagulation agents including aspirin, NSAIDs
- Prescription medications other than on a 6 month self-reported stable dose of medications for lipid lowering and/or hypertension.
- Vegan, Vegetarians, food faddists or those consuming a non-traditional diet
Show all 27Show fewer
- Fruit consumption ≥ 3 cups/day
- Regular consumption of strawberries (2-3 servings/week)
- Vegetable consumption ≥ 4 cups/day
- Coffee/tea ≥ 3 cups/day
- Dark chocolate ≥ 3 oz/day
- Self-reported restriction of physical activity due to a chronic health condition
- Self-reported chronic/routine high intensity exercise
- Self-reported diabetes
- Blood pressure ≥ 140/90 mm Hg
- Self-reported renal or liver disease
- Self-reported heart disease, which includes cardiovascular events and stroke
- Peripheral artery disease Raynaud's syndrome or disease
- Inability to properly place or wear the PAT probes or abnormal measurements on pre- screening PAT
- Abnormal Metabolic or CBC panels (laboratory values outside the reference range) if determined to be clinically significant by the study physician.
- Self-reported cancer within past 5 years
- Self-reported malabsorption
- Supplement use other than a general formula of vitamins and minerals that meet the RDA
- Not willing to stop any supplement use, including herbal, plant or botanical, fish oil, oil supplements a month prior to study enrollment.
- Indications of substance or alcohol abuse within the last 3 years
- Cannabis use
- Current enrollee in a clinical research study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis; Department of Nutrition
Davis, California, 95616
About this study
The overall objective of this proposed trial is to examine the vascular protective effects provided by the daily consumption of 39g of freeze dried strawberry powder (FDSP) for four weeks. The study population will be older men (60-80 years of age).
Read the detailed description
The proposed project will determine the influence of short-term FDSP intake on microvascular function in older men (60-80 years of age). The Framingham reactive hyperemia index (fRHI) will be used as a measure of microvascular function, and will be measured using peripheral arterial tonometry (PAT; EndoPAT200). Secondary outcomes will assess circulating levels of nitrate and nitrite, insulin-like growth factor (IGF), inflammatory cytokines, NADPH oxidase, platelet aggregation, plasma lipids and blood pressure. This suite of markers will provide insight on physiological outcomes and risk factors associated with CVD development, and the metabolic and signaling pathways that influence them. To accomplish the above, after a 4 week run in period of no powder intake, twenty men (60-80 years of age) will be randomly assigned to consume 39 g of FDSP or a control powder for four weeks in a randomized, double-blind, controlled crossover study. This study design will compare the short-term (four week) response of FDSP intake to an isocaloric control powder that provides no polyphenols, as well as to their habitual diet where no powder was consumed.
- Conditions
- Vascular Dilation
- Being tested
- freeze dried strawberry powder
- Keywords
- strawberry, diet, vascular function, inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
freeze dried strawberry powderOther
approximately 24 strawberries that have been freeze dried into a powder
| Study group | Role | What they receive |
|---|---|---|
| Freeze dried strawberry powder | Experimental | 39g of freeze dried strawberry powder, which represents three daily servings of strawberries.
The powder will be mixed in one cup of water. Receives: Other: freeze dried strawberry powder |
| control powder | Placebo comparator | 39 g of a powder that matches the sugar and caloric content of the experimental powder. The powder will be mixed in one cup of water. Receives: Other: freeze dried strawberry powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Framingham Reactive Hyperemia Index (fRHI)
fRHI as a measure of microvascular function will be measured by peripheral arterial tonometry (PAT).
Measured: 4 weeks
Secondary outcomes (5)
platelet aggregation
optimal platelet aggregometry using collagen and adp as agonist
Measured: 4 weeks
Th17 cytokines
TH17 Luminex panel: Interleukin (IL)-1b, IL-4, IL-6, IL-10, IL-17a, IL-21, IL-22, IL-23, IL-31, IL-33, IFNgamma, TNFalpha, IL-17f.
Measured: 4 weeks
insulin like growth factor (IGF) and binding proteins (IGFBP)
Luminex panel: IGF-1, -2 and IGFBP 1-7
Measured: 4 weeks
Nicotinamide adenine dinucleotide phosphate (NADPH) oxidase
soluble form marker of oxidative stress
Measured: 4 weeks
total nitrate and nitrite
plasma total nitrate and nitrite
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Dec 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Why it stopped: lack of recruiting progress
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DilationStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A randomized, double-blind, crossover dietary intervention trial.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carl L Keen, PhD, Principal investigator, Professor of Nutrition and Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763499
- Sponsor's protocol ID
- 1567320
- Status last verified
- May 2023
- First submitted
- 16 Feb 2021
- Last updated
- 11 May 2023
- 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 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Daily Strawberry Intake on Vascular Health in Elderly Men
- ClinicalTrials.gov ID
- NCT04763499
- Acronym / sponsor ID
- 1567320
- Conditions
- Vascular Dilation
- Keywords
- strawberry, diet, vascular function, inflammation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of recruiting progress
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 21 Feb 2021 (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.
The overall objective of this proposed trial is to examine the vascular protective effects provided by the daily consumption of 39g of freeze dried strawberry powder (FDSP) for four weeks. The study population will be older men (60-80 years of age).
Detailed description
The proposed project will determine the influence of short-term FDSP intake on microvascular function in older men (60-80 years of age). The Framingham reactive hyperemia index (fRHI) will be used as a measure of microvascular function, and will be measured using peripheral arterial tonometry (PAT; EndoPAT200). Secondary outcomes will assess circulating levels of nitrate and nitrite, insulin-like growth factor (IGF), inflammatory cytokines, NADPH oxidase, platelet aggregation, plasma lipids and blood pressure. This suite of markers will provide insight on physiological outcomes and risk factors associated with CVD development, and the metabolic and signaling pathways that influence them. To accomplish the above, after a 4 week run in period of no powder intake, twenty men (60-80 years of age) will be randomly assigned to consume 39 g of FDSP or a control powder for four weeks in a randomized, double-blind, controlled crossover study. This study design will compare the short-term (four week) response of FDSP intake to an isocaloric control powder that provides no polyphenols, as well as to their habitual diet where no powder was consumed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A randomized, double-blind, crossover dietary intervention trial.
| Arm | Type | Receives |
|---|---|---|
| Freeze dried strawberry powder | Experimental | Other: freeze dried strawberry powder39g of freeze dried strawberry powder, which represents three daily servings of strawberries. The powder will be mixed in one cup of water. |
| control powder | Placebo comparator | Other: freeze dried strawberry powder39 g of a powder that matches the sugar and caloric content of the experimental powder. The powder will be mixed in one cup of water. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject is willing and able to comply with the study protocols.
- Subject is willing to participate in all study procedures
- BMI 25.0 - 35 kg/m2
Key exclusion criteria (27 listed)
- BMI ≥ 35 kg/m2
- Visit 1 Reactive Hyperemia Index (RHI; EndoPAT 2000) ≥ 2.8
- Dislike or allergy strawberries
- Self-reported use of daily anticoagulation agents including aspirin, NSAIDs
- Prescription medications other than on a 6 month self-reported stable dose of medications for lipid lowering and/or hypertension.
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 powderapproximately 24 strawberries that have been freeze dried into a powder | Other | Freeze dried strawberry powder, control powder |
Primary outcome
Framingham Reactive Hyperemia Index (fRHI)
Time frame: 4 weeks
fRHI as a measure of microvascular function will be measured by peripheral arterial tonometry (PAT).
5 secondary outcomes
platelet aggregation
Time frame: 4 weeks
Th17 cytokines
Time frame: 4 weeks
insulin like growth factor (IGF) and binding proteins (IGFBP)
Time frame: 4 weeks
Nicotinamide adenine dinucleotide phosphate (NADPH) oxidase
Time frame: 4 weeks
total nitrate and nitrite
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: lack of recruiting progress). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Learn more or sign up for the study here!Link provided by the sponsor.
- 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.
Carl L Keen, PhD principal investigator
Professor of Nutrition and Internal Medicine
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 strawberry powder in people with Vascular Dilation, 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 27 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: stopped early, as of the sponsor's last update on 11 May 2023. 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 was stopped early (reason given: lack of recruiting progress). Results are not available in the source record.
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?
Framingham Reactive Hyperemia Index (fRHI) (time frame: 4 weeks). 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 11 May 2023.