Clinical trial NCT04094103: Strawberry Consumption in Overweight and Obese Individuals
Official title: Integrated Cardiovascular and Metabolic Effects of Strawberry Consumption in Overweight and Obese Individuals
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Metabolic Syndrome
Lead sponsor: Kansas State University
Sponsor class: OTHER
Collaborators: name: California Strawberry Commission
First posted: 2019-09-18
Enrollment: 48
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in plasma lipids
timeFrame: Week 0, 4, 5, 9, 10, and 14
Secondary outcomes:
measure: Change in glucose and insulin response
timeFrame: Week 0, 4, 5, 9, 10, and 14
measure: Change in oxidixed LDL
timeFrame: Week 0, 4, 5, 9, 10, and 14
measure: Change in homeostatic model assessment for insulin resistance
timeFrame: Week 0, 4, 5, 9, 10, and 14
measure: Change in inflammation
timeFrame: Week 0, 4, 5, 9, 10, and 14
measure: Change in arterial stiffness
timeFrame: Week 0, 4, 5, 9, 10, and 14
measure: Change in blood pressure (resting and 24-hr)
timeFrame: Week 0, 4, 5, 9, 10, and 14
measure: Change in endothelial function
timeFrame: Week 0, 4, 5, 9, 10, and 14
Other outcomes:
Locations:
city: Manhattan
country: United States
facility: Lafene Health Center
state: Kansas
Study officials:
affiliation: Kansas State University
name: Sara Rosenkranz, PhD
role: PRINCIPAL_INVESTIGATOR
References: