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
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.
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.
Exclusion Criteria:
Isocaloric powder
Other: Freeze Dried Strawberry Powder · Other: Isocaloric powder
Contains freeze dried strawberries
Other: Freeze Dried Strawberry Powder · Other: Isocaloric 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.
Isocaloric powder
Peripheral Arterial Tonometry (PAT)
microvascular function testing
Time frame: 10 weeks
Gut Microbiome
assessment of gut microbial populations
Time frame: 10 weeks
Untargeted Metabolomics
assessment of primary metabolites
Time frame: 10 weeks
Plasma Cholesterol
plasma cholesterol
Time frame: 10 weeks
Plasma LDL
LDL
Time frame: 10 weeks
Plasma HDL
HDL
Time frame: 10 weeks
Nitrate
Circulating levels of Nitrate
Time frame: 10 weeks
Nitrite
Circulating levels of Nitrite
Time frame: 10 weeks
Plan to share: No
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This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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University of California, Davis