Clinical trial NCT04763499: The Influence of Daily Strawberry Intake on Vascular Health in Elderly Men
Official title: The Influence of Daily Strawberry Intake on Vascular Health in Elderly Men
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Vascular Dilation
Keywords: strawberry, diet, vascular function, inflammation
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 4
Sex: MALE
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A randomized, double-blind, crossover dietary intervention trial.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Framingham Reactive Hyperemia Index (fRHI)
timeFrame: 4 weeks
Secondary outcomes:
measure: platelet aggregation
timeFrame: 4 weeks
measure: Th17 cytokines
timeFrame: 4 weeks
measure: insulin like growth factor (IGF) and binding proteins (IGFBP)
timeFrame: 4 weeks
measure: Nicotinamide adenine dinucleotide phosphate (NADPH) oxidase
timeFrame: 4 weeks
measure: total nitrate and nitrite
timeFrame: 4 weeks
Other outcomes:
measure: blood pressure
timeFrame: 4 weeks
measure: plasma lipids
timeFrame: 4 weeks
Locations:
city: Davis
country: United States
facility: University of California, Davis; Department of Nutrition
state: California
Study officials:
affiliation: Professor of Nutrition and Internal Medicine
name: Carl L Keen, PhD
role: PRINCIPAL_INVESTIGATOR
References: