The Influence of Daily Strawberry Intake on Vascular Health in Elderly Men

Vascular Dilation Clinical Trial

Official title:

The Influence of Daily Strawberry Intake on Vascular Health in Elderly Men

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04763499
• Other study ID #: 1567320
• Status: Terminated
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2023
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall objective of this proposed trial is to examine the vascular protective effects provided by the daily consumption of 39g of freeze dried strawberry powder (FDSP) for four weeks. The study population will be older men (60-80 years of age).

Description:

The proposed project will determine the influence of short-term FDSP intake on microvascular function in older men (60-80 years of age). The Framingham reactive hyperemia index (fRHI) will be used as a measure of microvascular function, and will be measured using peripheral arterial tonometry (PAT; EndoPAT200). Secondary outcomes will assess circulating levels of nitrate and nitrite, insulin-like growth factor (IGF), inflammatory cytokines, NADPH oxidase, platelet aggregation, plasma lipids and blood pressure. This suite of markers will provide insight on physiological outcomes and risk factors associated with CVD development, and the metabolic and signaling pathways that influence them. To accomplish the above, after a 4 week run in period of no powder intake, twenty men (60-80 years of age) will be randomly assigned to consume 39 g of FDSP or a control powder for four weeks in a randomized, double-blind, controlled crossover study. This study design will compare the short-term (four week) response of FDSP intake to an isocaloric control powder that provides no polyphenols, as well as to their habitual diet where no powder was consumed.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 60 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

• Visit 1 Reactive Hyperemia Index (RHI; EndoPAT 2000) = 2.8

• Dislike or allergy strawberries

• Self-reported use of daily anticoagulation agents including aspirin, NSAIDs

• Prescription medications other than on a 6 month self-reported stable dose of medications for lipid lowering and/or hypertension.

• Vegan, Vegetarians, food faddists or those consuming a non-traditional diet

• Fruit consumption = 3 cups/day

• Regular consumption of strawberries (2-3 servings/week)

• Vegetable consumption = 4 cups/day

• 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

• Peripheral artery disease Raynaud's syndrome or disease

• 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

• Supplement use 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

• Cannabis use

• Current enrollee in a clinical research study.

Related Conditions & MeSH terms

• Vascular Dilation

Intervention

Other:
• freeze dried strawberry powder
approximately 24 strawberries that have been freeze dried into a powder

Locations

Country	Name	City	State
United States	University of California, Davis; Department of Nutrition	Davis	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	blood pressure	systolic and diastolic blood pressure	4 weeks
Other	plasma lipids	clinical lipid panel	4 weeks
Primary	Framingham Reactive Hyperemia Index (fRHI)	fRHI as a measure of microvascular function will be measured by peripheral arterial tonometry (PAT).	4 weeks
Secondary	platelet aggregation	optimal platelet aggregometry using collagen and adp as agonist	4 weeks
Secondary	Th17 cytokines	TH17 Luminex panel: Interleukin (IL)-1b, IL-4, IL-6, IL-10, IL-17a, IL-21, IL-22, IL-23, IL-31, IL-33, IFNgamma, TNFalpha, IL-17f.	4 weeks
Secondary	insulin like growth factor (IGF) and binding proteins (IGFBP)	Luminex panel: IGF-1, -2 and IGFBP 1-7	4 weeks
Secondary	Nicotinamide adenine dinucleotide phosphate (NADPH) oxidase	soluble form marker of oxidative stress	4 weeks
Secondary	total nitrate and nitrite	plasma total nitrate and nitrite	4 weeks

External Links

•   Learn more or sign up for the study here!