search
Back to results

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

Primary Purpose

Microbial Colonization, Cardiovascular Diseases, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Freeze Dried Strawberry Powder
Isocaloric powder
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Microbial Colonization

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of California, Davis; Department of Nutrition

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control Powder

Freeze Dried Strawberry Powder

Arm Description

Isocaloric powder

Contains freeze dried strawberries

Outcomes

Primary Outcome Measures

Peripheral Arterial Tonometry (PAT)
microvascular function testing

Secondary Outcome Measures

Gut Microbiome
assessment of gut microbial populations
Untargeted Metabolomics
assessment of primary metabolites
Plasma Cholesterol
plasma cholesterol
Plasma LDL
LDL
Plasma HDL
HDL
Nitrate
Circulating levels of Nitrate
Nitrite
Circulating levels of Nitrite

Full Information

First Posted
September 13, 2017
Last Updated
June 2, 2022
Sponsor
University of California, Davis
search

1. Study Identification

Unique Protocol Identification Number
NCT03283969
Brief Title
Influence of Freeze Dried Strawberry Consumption on Gut Microbiota and Cardiovascular Health.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microbial Colonization, Cardiovascular Diseases, Obesity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized, double-blind, controlled crossover dietary intervention trial
Masking
ParticipantCare ProviderInvestigator
Masking Description
The test powders where pre-packaged by the study sponsor and sent to the investigators coded.
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Powder
Arm Type
Placebo Comparator
Arm Description
Isocaloric powder
Arm Title
Freeze Dried Strawberry Powder
Arm Type
Experimental
Arm Description
Contains freeze dried strawberries
Intervention Type
Other
Intervention Name(s)
Freeze Dried Strawberry Powder
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Isocaloric powder
Intervention Description
Isocaloric powder
Primary Outcome Measure Information:
Title
Peripheral Arterial Tonometry (PAT)
Description
microvascular function testing
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Gut Microbiome
Description
assessment of gut microbial populations
Time Frame
10 weeks
Title
Untargeted Metabolomics
Description
assessment of primary metabolites
Time Frame
10 weeks
Title
Plasma Cholesterol
Description
plasma cholesterol
Time Frame
10 weeks
Title
Plasma LDL
Description
LDL
Time Frame
10 weeks
Title
Plasma HDL
Description
HDL
Time Frame
10 weeks
Title
Nitrate
Description
Circulating levels of Nitrate
Time Frame
10 weeks
Title
Nitrite
Description
Circulating levels of Nitrite
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl L Keen, PhD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis; Department of Nutrition
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs