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

  • STATUS
    Recruiting
  • End date
    Dec 14, 2026
  • participants needed
    20
  • sponsor
    University of California, Davis
Updated on 24 January 2021

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.

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.

Details
Condition adiposity, Obesity, Cardiovascular Disease, Microbial Colonization, cardiovascular diseases, cardiovascular disease (cvd), cardiovascular system diseases, cardiovascular disorders
Treatment Freeze Dried Strawberry Powder, Isocaloric powder
Clinical Study IdentifierNCT03283969
SponsorUniversity of California, Davis
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 40 yrs and 65 yrs?
Gender: Male or Female
Do you have any of these conditions: Cardiovascular Disease or Obesity or Microbial Colonization?
Do you have any of these conditions: cardiovascular disorders or cardiovascular diseases or cardiovascular system diseases or adiposity or cardiovascular disease (cvd) or Microbial Coloni...?
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 prescreening 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>)
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