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

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ClinicalTrials.gov Identifier: NCT03283969
Recruitment Status : Recruiting
First Posted : September 15, 2017
Last Update Posted : June 2, 2021
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Brief 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 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.

Condition or disease Intervention/treatment Phase
Microbial Colonization Cardiovascular Diseases Obesity Other: Freeze Dried Strawberry Powder Other: Isocaloric powder Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized, double-blind, controlled crossover dietary intervention trial
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: The test powders where pre-packaged by the study sponsor and sent to the investigators coded.
Primary Purpose: Basic Science
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.
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Placebo Comparator: Control Powder
Isocaloric powder
Other: Freeze Dried Strawberry 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.

Other: Isocaloric powder
Isocaloric powder

Experimental: Freeze Dried Strawberry Powder
Contains freeze dried strawberries
Other: Freeze Dried Strawberry 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.

Other: Isocaloric powder
Isocaloric powder




Primary Outcome Measures :
  1. Peripheral Arterial Tonometry (PAT) [ Time Frame: 10 weeks ]
    microvascular function testing


Secondary Outcome Measures :
  1. Gut Microbiome [ Time Frame: 10 weeks ]
    assessment of gut microbial populations

  2. Untargeted Metabolomics [ Time Frame: 10 weeks ]
    assessment of primary metabolites

  3. Plasma Cholesterol [ Time Frame: 10 weeks ]
    plasma cholesterol

  4. Plasma LDL [ Time Frame: 10 weeks ]
    LDL

  5. Plasma HDL [ Time Frame: 10 weeks ]
    HDL

  6. Nitrate [ Time Frame: 10 weeks ]
    Circulating levels of Nitrate

  7. Nitrite [ Time Frame: 10 weeks ]
    Circulating levels of Nitrite



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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03283969


Contacts
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Contact: Carl L Keen, PhD 530-752-6331 clkeen@ucdavis.edu
Contact: Roberta Holt, PhD 530-752-4950 rrholt@ucdavis.edu

Locations
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United States, California
University of California, Davis; Department of Nutrition Recruiting
Davis, California, United States, 95616
Contact: Roberta Holt, PhD    530-752-4950    rrholt@ucdavis.edu   
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Carl L Keen, PhD University of California, Davis
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03283969    
Other Study ID Numbers: 956223
First Posted: September 15, 2017    Key Record Dates
Last Update Posted: June 2, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Communicable Diseases
Infections
Cardiovascular Diseases
Disease Attributes
Pathologic Processes