- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03283969
Influence of Freeze Dried Strawberry Consumption on Gut Microbiota and Cardiovascular Health.
June 2, 2022 updated by: University of California, Davis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Davis, California, United States, 95616
- University of California, Davis; Department of Nutrition
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control Powder
Isocaloric powder
|
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 powder
|
Experimental: Freeze Dried Strawberry Powder
Contains freeze dried strawberries
|
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 powder
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peripheral Arterial Tonometry (PAT)
Time Frame: 10 weeks
|
microvascular function testing
|
10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gut Microbiome
Time Frame: 10 weeks
|
assessment of gut microbial populations
|
10 weeks
|
Untargeted Metabolomics
Time Frame: 10 weeks
|
assessment of primary metabolites
|
10 weeks
|
Plasma Cholesterol
Time Frame: 10 weeks
|
plasma cholesterol
|
10 weeks
|
Plasma LDL
Time Frame: 10 weeks
|
LDL
|
10 weeks
|
Plasma HDL
Time Frame: 10 weeks
|
HDL
|
10 weeks
|
Nitrate
Time Frame: 10 weeks
|
Circulating levels of Nitrate
|
10 weeks
|
Nitrite
Time Frame: 10 weeks
|
Circulating levels of Nitrite
|
10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Carl L Keen, PhD, University of California, Davis
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2017
Primary Completion (Actual)
December 31, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
September 13, 2017
First Submitted That Met QC Criteria
September 14, 2017
First Posted (Actual)
September 15, 2017
Study Record Updates
Last Update Posted (Actual)
June 6, 2022
Last Update Submitted That Met QC Criteria
June 2, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 956223
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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