Strawberry Consumption in Overweight and Obese Individuals

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

Status: Completed

Conditions: Obesity; Metabolic Syndrome

Treatments: Dietary Supplement: Mixed strawberry powder; Dietary Supplement: Active strawberry powder; Dietary Supplement: Placebo strawberry powder

Study type: Interventional

Funder types: Other

Identifiers

NCT04094103

Pro9736

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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48 participants in 3 patient groups, including a placebo group

Active strawberry powder

Experimental group

Description:

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

Treatment:

Dietary Supplement: Active strawberry powder

Placebo strawberry powder

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo strawberry powder

Mixed active/placebo strawberry powder

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Mixed strawberry powder