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

Not Applicable

Terminated

• Conditions: Vascular Dilation
• Interventions: Other: freeze dried strawberry powder

• Registration Number: NCT04763499
• Lead Sponsor: University of California, Davis

Brief 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).

Detailed 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.

Study Timeline

• Study First Submitted: 2021-02-16
• Study First Submitted QC: 2021-02-18
• Study First Posted: 2021-02-21
• Study Start: 2021-12-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 4

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Freeze dried strawberry powder	freeze dried strawberry powder	39g of freeze dried strawberry powder, which represents three daily servings of strawberries. The powder will be mixed in one cup of water.
control powder	freeze dried strawberry powder	39 g of a powder that matches the sugar and caloric content of the experimental powder. The powder will be mixed in one cup of water.

Primary Outcome Measures

Name	Time	Method
Framingham Reactive Hyperemia Index (fRHI)	4 weeks	fRHI as a measure of microvascular function will be measured by peripheral arterial tonometry (PAT).

Secondary Outcome Measures

Name	Time	Method
insulin like growth factor (IGF) and binding proteins (IGFBP)	4 weeks	Luminex panel: IGF-1, -2 and IGFBP 1-7
Nicotinamide adenine dinucleotide phosphate (NADPH) oxidase	4 weeks	soluble form marker of oxidative stress
platelet aggregation	4 weeks	optimal platelet aggregometry using collagen and adp as agonist
total nitrate and nitrite	4 weeks	plasma total nitrate and nitrite
Th17 cytokines	4 weeks	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.

Trial Locations

Locations (1)

University of California, Davis; Department of Nutrition; 🇺🇸 Davis, California, United States