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Microbial ColonizationNCT03283969

Influence of Freeze Dried Strawberry Consumption on Gut Microbiota and Cardiovascular Health.

A study testing Freeze Dried Strawberry Powder and Isocaloric powder in people with Microbial Colonization and Cardiovascular Diseases, run by University of California, Davis at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This proposal seeks to build upon studies, including ours, on the favorable effects of California strawberries on vascular health. Freeze dried strawberry powder (FDSP) contains a number of nutrients that may have beneficial effects on plasma lipids and vascular function, as well as on the composition of the gut… Read more about this study

Who is it for?
Ages 40 to 65 yearsHealthy volunteers can take part
What is being tested?
Freeze Dried Strawberry Powder and Isocaloric powder
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
21 participants
Where
1 siteUnited States
Study dates
1 Aug 2017to 31 Dec 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 40 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male or postmenopausal female: 40-65 years
  • Women: lack of menses for at least two years.
  • 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
  • Dislike or allergy for strawberries or strawberry products
  • Self-reported use of daily anticoagulation agents including aspirin, NSAIDs
  • Vegan, Vegetarians, food faddists or those consuming a non-traditional diet
  • Fruit consumption ≥ 2 cups/day
  • Regular consumption of strawberries (2-3 cups/week)
Show all 28Show fewer
  • Vegetable consumption ≥ 3 cups/day for females
  • Fatty Fish ≥ 3 times/week
  • 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
  • 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
  • Currently taking prescription drugs or supplements.
  • Use of multi-vitamin and mineral 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
  • Screening LDL ≥ 190 mg/dl for those who have 0-1 major risk factors apart from LDL cholesterol (i.e. family history of premature coronary artery disease (male first degree relative < 55 years; CHD in female first degree relative < 65 years), cigarette smoker, HDL-C ≤ 40 mg/dL].
  • Screening LDL ≥ 160 mg/dl for those who have 2 major risk factors apart from LDL cholesterol [i.e. family history of premature coronary artery disease (male first degree relative < 55 years; CHD in female first degree relative < 65 years), cigarette smoker, HDL-C ≤ 40 mg/dL]. (using NCEP calculator http://cvdrisk.nhlbi.nih.gov/calculator.asp);
  • Screening LDL ≥ 130 mg/dl for those who have 2 major risk factors apart from LDL cholesterol [i.e. family history of premature coronary artery disease (male first degree relative < 55 years; CHD in female first degree relative < 65 years), cigarette smoker, HDL-C ≤ 40 mg/dL], and a Framingham 10-year Risk Score 10-20% (using NCEP calculator http://cvdrisk.nhlbi.nih.gov/calculator.asp).
  • 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

Other trials in United States

About this study

Official title: Probe Study Investigation on the Influence of Freeze Dried Strawberry Consumption on Gut Microbiota, Intestinal Health, Metabolic Phenotype and Cardiovascular Risk in Overweight and Obese Individuals.

This proposal seeks to build upon studies, including ours, on the favorable effects of California strawberries on vascular health. Freeze dried strawberry powder (FDSP) contains a number of nutrients that may have beneficial effects on plasma lipids and vascular function, as well as on the composition of the gut microbiota; changes in the gut microbiota can in turn have secondary positive effects on the vascular system as well as on other physiological functions that are important determinants of health and disease. The proposed project will seek to determine the influence of short-term FDSP intake on the gut microbiota composition, and select microbial-derived metabolites from stool, serum and urine, and their relationship to microvascular function. Secondary outcomes will include the influence of the FDSP on circulating levels of nitrate and nitrite and trimethylamine oxide (TMAO) as markers of vascular health that are influenced by both dietary intake and the oral and gut microflora, with blood pressure as an additional vascular outcome.

Read the detailed description

A randomized, double-blind, controlled crossover design will compare the short-term (two and four week) response to FDSP intake compared to an isocaloric control powder in overweight and obese adults. Twenty overweight or obese male or postmenopausal females (40-65 years of age) will be randomized to consume 39 g of FDSP or a control powder for four weeks in a crossover design with a four week washout period. Changes in stool microbial communities and microbial metabolites will be assessed, and examined for their potential influence on microvascular function.

Being tested
Freeze Dried Strawberry Powder, Isocaloric powder
Medical subject headings
Communicable Diseases, Cardiovascular Diseases, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Freeze Dried Strawberry PowderOther

    Study participants will be randomized to receive either the freeze dried strawberry powder or the control powder first. They will be instructed to consume 39g of the powder, mixed in water, every day for 4 weeks.

  • Isocaloric powderOther

    Isocaloric powder

Study groups in NCT03283969
Study groupRoleWhat they receive
Control PowderPlacebo comparatorIsocaloric powder
Receives: Other: Freeze Dried Strawberry Powder; Other: Isocaloric powder
Freeze Dried Strawberry PowderExperimentalContains freeze dried strawberries
Receives: Other: Freeze Dried Strawberry Powder; Other: Isocaloric powder

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peripheral Arterial Tonometry (PAT)

    microvascular function testing

    Measured: 10 weeks

Secondary outcomes (7)

  1. Gut Microbiome

    assessment of gut microbial populations

    Measured: 10 weeks

  2. Untargeted Metabolomics

    assessment of primary metabolites

    Measured: 10 weeks

  3. Plasma Cholesterol

    plasma cholesterol

    Measured: 10 weeks

  4. Plasma LDL

    LDL

    Measured: 10 weeks

  5. Plasma HDL

    HDL

    Measured: 10 weeks

  6. Nitrate

    Circulating levels of Nitrate

    Measured: 10 weeks

  7. Nitrite

    Circulating levels of Nitrite

    Measured: 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2017
  2. Study start1 Aug 2017
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2021

Resources

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
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
Randomized, double-blind, controlled crossover dietary intervention trial
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03283969
Sponsor's protocol ID
956223
Status last verified
Jun 2022
First submitted
13 Sep 2017
Last updated
6 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Freeze Dried Strawberry Powder and Isocaloric powder in people with Microbial Colonization and Cardiovascular Diseases, 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 5 inclusion and 28 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 6 Jun 2022. 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?

Peripheral Arterial Tonometry (PAT) (time frame: 10 weeks). 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 NCT03283969.

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 6 Jun 2022.

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