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Completed

NCT Number: NCT04094103

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.

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Key information

Conditions

Obesity Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lafene Health Center

Manhattan, Kansas, 66502, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Active strawberry powder

Dietary Supplement

Participants will drink a strawberry beverage with active ingredients once a day during the 4-week intervention period.

Placebo strawberry powder

Dietary Supplement

Participants will drink a strawberry placebo beverage once a day during the 4-week intervention period.

Mixed strawberry powder

Dietary Supplement

Participants will drink a mixed strawberry beverage with active ingredients and placebo once a day during the 4-week intervention period.

Primary outcomes

  1. Change in plasma lipids

    Time frame: Week 0, 4, 5, 9, 10, and 14

    Total cholesterol (TC), LDL-c , VLDL-c, HDL-c , triglycerides (TG) from blood sample in a fasted state and following consumption of a meal

Secondary outcomes

  1. Change in glucose and insulin response

    Time frame: Week 0, 4, 5, 9, 10, and 14

    Glucose, insulin, and c-peptide obtained from blood sample in a fasted state and in response to a meal

  2. Change in oxidixed LDL

    Time frame: Week 0, 4, 5, 9, 10, and 14

    Obtained from blood sample in a fasted state and following consumption of a meal

  3. Change in homeostatic model assessment for insulin resistance

    Time frame: Week 0, 4, 5, 9, 10, and 14

    Calculated from fasting glucose and insulin values

  4. Change in inflammation

    Time frame: Week 0, 4, 5, 9, 10, and 14

    hs-CRP and IL-6 will be assessed in the fasted state from plasma

  5. Change in arterial stiffness

    Time frame: Week 0, 4, 5, 9, 10, and 14

    Determined via changes in carotid artery stiffness calculated from simultaneous measurements of carotid artery diameter and pressure-waveforms

  6. Change in blood pressure (resting and 24-hr)

    Time frame: Week 0, 4, 5, 9, 10, and 14

    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.

  7. Change in endothelial function

    Time frame: Week 0, 4, 5, 9, 10, and 14

    Flow mediated dilation (FMD) assessed via a non-invasive 2D Doppler ultrasound following a 5-min period of arterial occlusion.

Sponsors and collaborators

Lead sponsor

Carl Ade, M.S., Ph.D.

Other

Collaborators

  • California Strawberry Commission

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Sep 18, 2019
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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