Completed

The Effects of California Strawberries on Parameters of Cardiovascular Health

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

flavonoid-rich freeze-dried strawberry powder

+ macronutrient-matched control powder

Dietary Supplement
Who is being recruted

Body Weight+7

+ Nutrition Disorders

+ Nutritional and Metabolic Diseases

From 14 to 18 Years
+20 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-ControlledPhase 2
Interventional
Study Start: May 2012
See protocol details

Summary

Principal SponsorUniversity of California, Davis
Last updated: July 14, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2012

Actual date on which the first participant was enrolled.

The prevalence of childhood obesity has been increasing over the past couple of decades. Similar to adults, overweight and obesity in young children and adolescents is associated with an increased number of cardiovascular risk factors including dyslipidemia, hypertension, insulin resistance and Type 2 diabetes. Epidemiological and clinical studies suggest that foods and ingredients rich in select flavonoids, such as cocoa, red grape products, tea, citrus fruits, and strawberries are protective against the development of cardiovascular disease. Strawberries are rich in flavonoids, particularly anthocyanins, flavanols, flavonols, ellagic acid and its glucose ester, ellagitanin. A number of in vitro studies have observed that these isolated compounds, as well as strawberry extracts have the potential to affect outcomes of cardiovascular health, including vascular reactivity, cellular signaling and oxidant defense6,7. We hypothesize that strawberry intake will lead to improvements in select measures of cardiovascular function in overweight and obese adolescent males.

Principal SponsorUniversity of California, Davis
Last updated: July 14, 2017
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

32 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

Male

Biological sex of participants that are eligible to enroll.

From 14 to 18 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 WeightNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionOverweightCardiovascular DiseasesObesityPediatric Obesity

Criteria

3 inclusion criteria required to participate
BMI for age and gender > 75th percentile (based on CDC growth charts)

Male subjects, age 14 - 18 years

Subject is willing and able to comply with the study protocols

17 exclusion criteria prevent from participating
Abnormal Liver, CBC or Chemistry panels (laboratory values outside the reference

Allergies to fruit

Asthma (can be worsened by mild to moderate food allergies)

BMI for age and gender <= 75th percentile (based on CDC growth charts)

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

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
50g of flavonoid-rich freeze-dried strawberry powder

Group II

Placebo
50g macronutrient-matched control powder that will lack strawberry flavonoids

Study Objectives

Primary 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

Ragle Human Nutrition Research Center, Academic Surge, UC Davis

Davis, United StatesOpen Ragle Human Nutrition Research Center, Academic Surge, UC Davis in Google Maps
CompletedOne Study Center