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

NCT03283969 | Completed

• 1 other identifier: 956223
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Microbial Colonization; Cardiovascular Diseases; Obesity

Outcome Measures

Primary Outcomes (1)

• Peripheral Arterial Tonometry (PAT)

  microvascular function testing

  10 weeks

Secondary Outcomes (7)

• Gut Microbiome

  10 weeks

• Untargeted Metabolomics

  10 weeks

• Plasma Cholesterol

  10 weeks

• Plasma LDL

  10 weeks

• Plasma HDL

  10 weeks

Study Arms (2)

Control Powder

PLACEBO COMPARATOR

Isocaloric powder

Other: Freeze Dried Strawberry Powder; Other: Isocaloric powder

Freeze Dried Strawberry Powder

EXPERIMENTAL

Contains freeze dried strawberries

Other: Freeze Dried Strawberry Powder; Other: Isocaloric powder

Interventions

Freeze Dried Strawberry Powder OTHER

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.

Control Powder; Freeze Dried Strawberry Powder

Isocaloric powder OTHER

Isocaloric powder

Control Powder; Freeze Dried Strawberry Powder

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis; Department of Nutrition

Davis, California, 95616, United States

Location

MeSH Terms

Conditions

Communicable Diseases; Cardiovascular Diseases; Obesity

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Study Officials

• Carl L Keen, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The test powders where pre-packaged by the study sponsor and sent to the investigators coded.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, controlled crossover dietary intervention trial

Study Record Dates

• First Submitted: September 13, 2017
• First Posted: September 15, 2017
• Study Start: August 1, 2017
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: June 6, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)