Strawberry Consumption in Overweight and Obese Individuals

Integrated Cardiovascular and Metabolic Effects of Strawberry Consumption in Overweight and Obese Individuals

Our proposal represents an integrated approach to determining the cardiovascular and metabolic effects of strawberry consumption in adults who have high risk for cardiometabolic disease.

Study Overview

• Status: Completed
• Conditions: Obesity; Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: Active strawberry powder; Dietary supplement: Placebo strawberry powder; Dietary supplement: Mixed strawberry powder

Detailed Description

The current proposal aims to fill some of these important research gaps with regard the dose and time-course of strawberry consumption in a population where dietary intervention may of particular benefit for both primary and secondary prevention of cardiovascular and metabolic disease. Participants will participate in a double blind, placebo-controlled, randomized crossover trial. Following a 10-day run-in where no berries are consumed, participants will be randomized via Latin-square design, to three different daily strawberry powder conditions for 4-weeks at a time, with a 7 day washout between conditions.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Manhattan, Kansas, United States, 66502
      • Lafene Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Overweight or obese by BMI (25.0-34.9kg/m2),
• Borderline-high LDL-cholesterol (130-159mg/dL),
• Normal or elevated blood pressure ((≤129mmHg/≤80mmHg)

Exclusion Criteria:

• known allergy or intolerance to strawberries
• taking any medications for chronic diseases including anti-inflammatory, anti-hypertensive, lipid-lowering, glucose-controlling, or steroidal medications
• taking any supplements that might affect outcomes of the study including anti-oxidant or fish-oil supplements
• having anemia or any liver, thyroid, renal conditions
• current smoker or user of tobacco products, or use within the past three months
• consuming alcohol (>1-2 drinks/day) on a regular basis
• currently pregnant or lactating
• having elevated blood pressure ≥130mmHg/≥80mmHg
• presence of diagnosed diabetes mellitus, inflammatory disease, atherosclerotic disease, or other relevant chronic conditions
• total cholesterol ≥240mg/dL
• hemoglobin normal range values for males (between 13.0-17.5g/dL) and females (between 12.5-15.5g/dL)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active strawberry powder; Participants will consume a 39g freeze-dried active strawberry powder beverage once per day for 4-weeks.	Dietary supplement: Active strawberry powder; Participants will drink a strawberry beverage with active ingredients once a day during the 4-week intervention period.
Placebo Comparator: Placebo strawberry powder; Participants will consume a 39g freeze-dried strawberry powder placebo beverage once per day for 4-weeks.	Dietary supplement: Placebo strawberry powder; Participants will drink a strawberry placebo beverage once a day during the 4-week intervention period.
Active Comparator: Mixed active/placebo strawberry powder; Participants will consume a 39g mixed active/placebo strawberry powder beverage once per day for 4-weeks.	Dietary supplement: Mixed strawberry powder; Participants will drink a mixed strawberry beverage with active ingredients and placebo once a day during the 4-week intervention period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in plasma lipids	Total cholesterol (TC), LDL-c , VLDL-c, HDL-c , triglycerides (TG) from blood sample in a fasted state and following consumption of a meal	Week 0, 4, 5, 9, 10, and 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in glucose and insulin response	Glucose, insulin, and c-peptide obtained from blood sample in a fasted state and in response to a meal	Week 0, 4, 5, 9, 10, and 14
Change in oxidixed LDL	Obtained from blood sample in a fasted state and following consumption of a meal	Week 0, 4, 5, 9, 10, and 14
Change in homeostatic model assessment for insulin resistance	Calculated from fasting glucose and insulin values	Week 0, 4, 5, 9, 10, and 14
Change in inflammation	hs-CRP and IL-6 will be assessed in the fasted state from plasma	Week 0, 4, 5, 9, 10, and 14
Change in arterial stiffness	Determined via changes in carotid artery stiffness calculated from simultaneous measurements of carotid artery diameter and pressure-waveforms	Week 0, 4, 5, 9, 10, and 14
Change in blood pressure (resting and 24-hr)	Evaluated via automated sphygmomanometer. 24-hr ambulatory blood pressure is taken at 20-30 minute intervals over a 24hr period while the individual goes about their normal activities and while sleeping.	Week 0, 4, 5, 9, 10, and 14
Change in endothelial function	Flow mediated dilation (FMD) assessed via a non-invasive 2D Doppler ultrasound following a 5-min period of arterial occlusion.	Week 0, 4, 5, 9, 10, and 14

Collaborators and Investigators

• Sponsor: Carl Ade, M.S., Ph.D.
• Collaborators: California Strawberry Commission
• Investigators: Principal Investigator: Sara Rosenkranz, PhD, Kansas State University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): October 27, 2023
• Study Completion (Actual): October 27, 2023

Study Registration Dates

• First Submitted: September 13, 2019
• First Submitted That Met QC Criteria: September 16, 2019
• First Posted (Actual): September 18, 2019

Study Record Updates

• Last Update Posted (Estimated): September 2, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Metabolic Syndrome
• Other Study ID Numbers: Pro9736

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No