Completed

Strawberry Consumption Effects on Cardiovascular and Metabolic Health in Overweight and Obese Individuals

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Study Aim

This study aims to evaluate how consuming strawberries can prevent cardiovascular and metabolic health issues in overweight and obese individuals, primarily by observing changes in plasma lipids such as total cholesterol, LDL-c, VLDL-c, HDL-c, and triglycerides.

What is being tested

Active strawberry powder

+ Placebo strawberry powder

+ Mixed strawberry powder

Dietary Supplement
Who is being recruted

Body Weight+10

+ Hyperinsulinism

+ Insulin Resistance

From 35 to 75 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-Controlled
Interventional
Study Start: October 2019
See protocol details

Summary

Principal SponsorCarl Ade, M.S., Ph.D.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2019

Actual date on which the first participant was enrolled.

This study focuses on understanding the effects of strawberry consumption on heart health and metabolism in individuals who are overweight or obese. The research aims to fill key gaps in our knowledge about the ideal dose and duration of strawberry intake. This could potentially help in preventing heart and metabolic diseases, both as a first step and a follow-up to other treatments. The study is particularly interested in this group as dietary changes might bring significant benefits for them. Participants will take part in a well-structured trial where they will be randomly assigned to different groups, ensuring fairness. After a 10-day period without consuming any berries, they will receive different amounts of strawberry powder daily for 4-week periods. There will be a 7-day break between each period. The study will measure changes in various types of cholesterol and fats in the blood, both in a fasting state and after a meal. This will help understand how strawberry consumption affects these important health markers.

Official TitleIntegrated Cardiovascular and Metabolic Effects of Strawberry Consumption in Overweight and Obese Individuals
NCT04094103
Principal SponsorCarl Ade, M.S., Ph.D.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

48 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 35 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightHyperinsulinismInsulin ResistanceMetabolic DiseasesNutrition DisordersNutritional and Metabolic DiseasesObesitySigns and SymptomsPathological Conditions, Signs and SymptomsMetabolic SyndromeOvernutritionGlucose Metabolism DisordersOverweight

Criteria

3 inclusion criteria required to participate
Overweight or obese by BMI (25.0-34.9kg/m2),
Borderline-high LDL-cholesterol (130-159mg/dL),
Normal or elevated blood pressure ((≤129mmHg/≤80mmHg)
11 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Participants will consume a 39g freeze-dried active strawberry powder beverage once per day for 4-weeks.

Group II

Placebo
Participants will consume a 39g freeze-dried strawberry powder placebo beverage once per day for 4-weeks.

Group III

Active Comparator
Participants will consume a 39g mixed active/placebo strawberry powder beverage once per day for 4-weeks.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Lafene Health Center

Manhattan, United StatesOpen Lafene Health Center in Google Maps
CompletedOne Study Center
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