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

NCT ID: NCT04763499

Last Updated: 2023-05-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2022-12-31

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.

Conditions

Vascular Dilation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

freeze dried strawberry powder

Intervention Type: OTHER

approximately 24 strawberries that have been freeze dried into a powder

control 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.

Group Type: PLACEBO_COMPARATOR

freeze dried strawberry powder

Intervention Type: OTHER

approximately 24 strawberries that have been freeze dried into a powder

Interventions

freeze dried strawberry powder

approximately 24 strawberries that have been freeze dried into a powder

Intervention Type: OTHER

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carl L Keen, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor of Nutrition and Internal Medicine

Locations

University of California, Davis; Department of Nutrition

Davis, California, United States

Countries

United States

Related Links

https://studypages.com/s/are-you-a-man-between-60-and-80-years-old-help-us-learn-about-how-strawberries-influence-your-health-423731/

Learn more or sign up for the study here!

Other Identifiers

1567320

Identifier Type: -

Identifier Source: org_study_id