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CompletedNCT03283969Updated Jun 6, 2022

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

An interventional study of Freeze Dried Strawberry Powder and Isocaloric powder in Microbial Colonization, Cardiovascular Diseases and Obesity, sponsored by University of California, Davis. Completed at 1 site in United States. Open to participants aged 40 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-06.

Sponsored by University of California, Davis · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
40 Years to 65 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Microbial Colonization
  • Cardiovascular Diseases
  • Obesity
03

Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
21 participants (actual)

Study arms

  • Placebo comparator
    Control Powder

    Isocaloric powder

    Other: Freeze Dried Strawberry Powder · Other: Isocaloric powder

  • Experimental
    Freeze Dried Strawberry Powder

    Contains freeze dried strawberries

    Other: Freeze Dried Strawberry Powder · Other: Isocaloric powder

Interventions

  • OtherFreeze 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.

  • OtherIsocaloric powder

    Isocaloric powder

05

What researchers measure

Primary outcomes

  1. Peripheral Arterial Tonometry (PAT)

    microvascular function testing

    Time frame: 10 weeks

Secondary outcomes

  1. Gut Microbiome

    assessment of gut microbial populations

    Time frame: 10 weeks

  2. Untargeted Metabolomics

    assessment of primary metabolites

    Time frame: 10 weeks

  3. Plasma Cholesterol

    plasma cholesterol

    Time frame: 10 weeks

  4. Plasma LDL

    LDL

    Time frame: 10 weeks

  5. Plasma HDL

    HDL

    Time frame: 10 weeks

  6. Nitrate

    Circulating levels of Nitrate

    Time frame: 10 weeks

  7. Nitrite

    Circulating levels of Nitrite

    Time frame: 10 weeks

06

Study locations

1 site
  • University of California, Davis; Department of Nutrition
    Davis, California 95616, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03283969
Lead sponsor
University of California, Davis
Responsible party
Sponsor
First posted
Sep 15, 2017
Start date
Aug 1, 2017
Primary completion
Dec 31, 2021
Completion
Dec 31, 2021
Last update
Jun 6, 2022

Study contacts

Carl L Keen, PhD
principal investigator · University of California, Davis

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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