Effects of Freeze Dried Strawberry Powder Supplementation on Cardiovascular Risk Factors and Gut Microbiome

Cardiovascular Risk Factor Clinical Trial

Official title:

Effects of Freeze Dried Strawberry Powder Supplementation on Vascular Function, Blood Markers of Cardiovascular Risk, and the Gut Microbiome

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03522974
• Other study ID #: Strawberry Study
• Status: Terminated
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: March 23, 2021

Study information

• Verified date: February 2024
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Dietary interventions designed to promote health by increasing the consumption of particular health-promoting foods (e.g., strawberries) generally target blood pressure and LDL-C; however, CVD risk reduction may also be achieved via changes in emerging endpoints such as the gut microbiome. Previous research suggests that strawberries have the potential to reduce LDL-C, but it remains unclear whether there is a dose-response relationship. Moreover, few studies have evaluated effects on vascular health or characterized changes in the gut microbiome following daily strawberry consumption. Additionally, previous studies have largely been conducted among Caucasian populations. Given the demographics of the US, it is important to evaluate effects in study populations that include ethnicities that may have higher risk of type 2 diabetes and/or other CVD risk factors, such as Hispanics. This study aims to examine the effects of 4 weeks of supplementation with two doses of freeze dried strawberry powder (low dose: 13 g/d and high dose: 40 g/d) on: 1) LDL-C and blood pressure; 2) gut microbiome profile; and 3) other CVD and type 2 diabetes risk factors, including glucose, insulin, and inflammatory markers. Overweight (BMI 25-36 kg/m2) but otherwise healthy adults with moderately elevated LDL-C (>3.0 mmol/L) and/or prehypertension (120-159/80-99 mm Hg) will be enrolled. This will optimize the potential for observing significant benefits on these outcomes. 50 eligible participants will be recruited with the expectation that at least 40 will complete the study. The placebo-controlled, crossover study design will allow for a direct comparison of dose-response within the same participant. The investigators anticipate that the bioactive components of strawberries will reduce LDL-C and blood pressure, and modify the gut microbiome, with greater changes on the high dose. There is preliminary evidence that polyphenol-rich foods can modify gut microbiota profiles, but this would be the first study to characterize the effects of daily strawberry consumption. The investigators are uniquely placed at the University of Arizona to enroll a larger percentage of Hispanic participants, who are often under-represented in clinical nutritional research. Results from the proposed study will improve understanding of how strawberries might promote health, and could provide further support for the incorporation of whole freeze dried fruit in dietary guidelines.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: March 23, 2021
• Est. primary completion date: March 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• At least one of the following:
• LDL-C above 3.0 mmol/L (116 mg/dL)
• Systolic blood pressure of 120-159 mmHg
• Diastolic blood pressure of 80-99 mmHg
• Total cholesterol below 6.2 mmol/L (240 mg/dL)
• Triglycerides below 350 mg/dL

Exclusion Criteria:

• Allergies to strawberries
• History of CVD, Stage II hypertension (BP = 160/100 mmHg), kidney disease, diabetes, or inflammatory diseases such as GI disorders and rheumatoid arthritis
• Use of medications/supplements for elevated lipids, blood pressure, or glucose
• Chronic use of non-steroidal anti-inflammatory or immunosuppressant drugs
• Conditions requiring chronic use of steroids

Related Conditions & MeSH terms

• Cardiovascular Risk Factor

Intervention

Dietary Supplement:
• Strawberry powder
Freeze dried strawberry powder
• Placebo powder
40 g/d placebo powder matched for taste and appearance

Locations

Country	Name	City	State
United States	University of Arizona	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

References & Publications (11)

Basu A, Betts NM, Nguyen A, Newman ED, Fu D, Lyons TJ. Freeze-dried strawberries lower serum cholesterol and lipid peroxidation in adults with abdominal adiposity and elevated serum lipids. J Nutr. 2014 Jun;144(6):830-7. doi: 10.3945/jn.113.188169. Epub 2014 Mar 26. — View Citation

Burton-Freeman B, Linares A, Hyson D, Kappagoda T. Strawberry modulates LDL oxidation and postprandial lipemia in response to high-fat meal in overweight hyperlipidemic men and women. J Am Coll Nutr. 2010 Feb;29(1):46-54. doi: 10.1080/07315724.2010.10719816. — View Citation

Erlund I, Koli R, Alfthan G, Marniemi J, Puukka P, Mustonen P, Mattila P, Jula A. Favorable effects of berry consumption on platelet function, blood pressure, and HDL cholesterol. Am J Clin Nutr. 2008 Feb;87(2):323-31. doi: 10.1093/ajcn/87.2.323. — View Citation

Espin JC, Larrosa M, Garcia-Conesa MT, Tomas-Barberan F. Biological significance of urolithins, the gut microbial ellagic Acid-derived metabolites: the evidence so far. Evid Based Complement Alternat Med. 2013;2013:270418. doi: 10.1155/2013/270418. Epub 2013 May 28. — View Citation

Jennings A, Welch AA, Fairweather-Tait SJ, Kay C, Minihane AM, Chowienczyk P, Jiang B, Cecelja M, Spector T, Macgregor A, Cassidy A. Higher anthocyanin intake is associated with lower arterial stiffness and central blood pressure in women. Am J Clin Nutr. 2012 Oct;96(4):781-8. doi: 10.3945/ajcn.112.042036. Epub 2012 Aug 22. — View Citation

Park E, Edirisinghe I, Wei H, Vijayakumar LP, Banaszewski K, Cappozzo JC, Burton-Freeman B. A dose-response evaluation of freeze-dried strawberries independent of fiber content on metabolic indices in abdominally obese individuals with insulin resistance in a randomized, single-blinded, diet-controlled crossover trial. Mol Nutr Food Res. 2016 May;60(5):1099-109. doi: 10.1002/mnfr.201500845. Epub 2016 Mar 29. — View Citation

Richter CK, Skulas-Ray AC, Gaugler TL, Lambert JD, Proctor DN, Kris-Etherton PM. Incorporating freeze-dried strawberry powder into a high-fat meal does not alter postprandial vascular function or blood markers of cardiovascular disease risk: a randomized controlled trial. Am J Clin Nutr. 2017 Feb;105(2):313-322. doi: 10.3945/ajcn.116.141804. Epub 2016 Dec 21. — View Citation

Tuohy KM, Conterno L, Gasperotti M, Viola R. Up-regulating the human intestinal microbiome using whole plant foods, polyphenols, and/or fiber. J Agric Food Chem. 2012 Sep 12;60(36):8776-82. doi: 10.1021/jf2053959. Epub 2012 Jun 12. — View Citation

U.S. Department of Health and Human Services and U.S. Department of Agriculture, 2015-2020 Dietary Guidelines for Americans, 2015.

Vendrame S, Guglielmetti S, Riso P, Arioli S, Klimis-Zacas D, Porrini M. Six-week consumption of a wild blueberry powder drink increases bifidobacteria in the human gut. J Agric Food Chem. 2011 Dec 28;59(24):12815-20. doi: 10.1021/jf2028686. Epub 2011 Nov 18. — View Citation

Zunino SJ, Parelman MA, Freytag TL, Stephensen CB, Kelley DS, Mackey BE, Woodhouse LR, Bonnel EL. Effects of dietary strawberry powder on blood lipids and inflammatory markers in obese human subjects. Br J Nutr. 2012 Sep;108(5):900-9. doi: 10.1017/S0007114511006027. Epub 2011 Nov 9. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gut microbiome	Composition of the gut microbial community measured by high-throughput 16S rRNA sequencing	4-6 weeks
Primary	LDL-C/non-HDL-C		4-6 weeks
Primary	Brachial and central blood pressure	systolic and diastolic blood pressures	4-6- weeks
Secondary	Pulse Wave Velocity (PWV)		4-6 weeks
Secondary	Augmentation Index	augmentation index corrected for heart rate	4-6 weeks
Secondary	Other lipids and lipoproteins	HDL-C, total cholesterol, and triglycerides	4-6 weeks
Secondary	Glucose	fasting glucose	4-6 weeks
Secondary	Insulin	fasting insulin	4-6 weeks