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

Primary Purpose

Vascular Dilation

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

freeze dried strawberry powder

About this trial

This is an interventional prevention trial for Vascular Dilation focused on measuring strawberry, diet, vascular function, inflammation

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

University of California, Davis; Department of Nutrition

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Freeze dried strawberry powder

control powder

Arm Description

39g of freeze dried strawberry powder, which represents three daily servings of strawberries. The powder will be mixed in one cup of water.

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.

Outcomes

Primary Outcome Measures

Framingham Reactive Hyperemia Index (fRHI)

fRHI as a measure of microvascular function will be measured by peripheral arterial tonometry (PAT).

Secondary Outcome Measures

platelet aggregation

optimal platelet aggregometry using collagen and adp as agonist

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.

insulin like growth factor (IGF) and binding proteins (IGFBP)

Luminex panel: IGF-1, -2 and IGFBP 1-7

Nicotinamide adenine dinucleotide phosphate (NADPH) oxidase

soluble form marker of oxidative stress

total nitrate and nitrite

plasma total nitrate and nitrite

Full Information

NCT ID

NCT04763499

First Posted

February 16, 2021

Last Updated

May 9, 2023

Sponsor

University of California, Davis

1. Study Identification

Unique Protocol Identification Number

NCT04763499

Brief Title

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

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Terminated

Why Stopped

lack of recruiting progress

Study Start Date

December 1, 2021 (Actual)

Primary Completion Date

December 31, 2022 (Actual)

Study Completion Date

December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, Davis

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vascular Dilation

Keywords

strawberry, diet, vascular function, inflammation

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

A randomized, double-blind, crossover dietary intervention trial.

Masking

ParticipantInvestigator

Masking Description

both the control and freeze dried strawberry powders are package with only a code as the identifier

Allocation

Randomized

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Freeze dried strawberry powder

Arm Type

Experimental

Arm Description

39g of freeze dried strawberry powder, which represents three daily servings of strawberries. The powder will be mixed in one cup of water.

Arm Title

control powder

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

freeze dried strawberry powder

Intervention Description

approximately 24 strawberries that have been freeze dried into a powder

Primary Outcome Measure Information:

Title

Framingham Reactive Hyperemia Index (fRHI)

Description

fRHI as a measure of microvascular function will be measured by peripheral arterial tonometry (PAT).

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

platelet aggregation

Description

optimal platelet aggregometry using collagen and adp as agonist

Time Frame

4 weeks

Title

Th17 cytokines

Description

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.

Time Frame

4 weeks

Title

insulin like growth factor (IGF) and binding proteins (IGFBP)

Description

Luminex panel: IGF-1, -2 and IGFBP 1-7

Time Frame

4 weeks

Title

Nicotinamide adenine dinucleotide phosphate (NADPH) oxidase

Description

soluble form marker of oxidative stress

Time Frame

4 weeks

Title

total nitrate and nitrite

Description

plasma total nitrate and nitrite

Time Frame

4 weeks

Other Pre-specified Outcome Measures:

Title

blood pressure

Description

systolic and diastolic blood pressure

Time Frame

4 weeks

Title

plasma lipids

Description

clinical lipid panel

Time Frame

4 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carl L Keen, PhD

Organizational Affiliation

Professor of Nutrition and Internal Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California, Davis; Department of Nutrition

City

Davis

State/Province

California

ZIP/Postal Code

95616

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

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

Description

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

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