Strawberry Consumption in Overweight and Obese Individuals

Not Applicable

• Conditions: Obesity; Metabolic Syndrome
• Interventions: Dietary Supplement: Placebo strawberry powder; Dietary Supplement: Active strawberry powder; Dietary Supplement: Mixed strawberry powder

• Registration Number: NCT04094103
• Lead Sponsor: Carl Ade, M.S., Ph.D.

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.

Study Timeline

• Study First Submitted: 2019-09-13
• Study First Submitted QC: 2019-09-16
• Study First Posted: 2019-09-18
• Study Start: 2019-10-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-30
• Last Update Posted: 2022-03-31
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo strawberry powder	Placebo strawberry powder	Participants will consume a 39g freeze-dried strawberry powder placebo beverage once per day for 4-weeks.
Active strawberry powder	Active strawberry powder	Participants will consume a 39g freeze-dried active strawberry powder beverage once per day for 4-weeks.
Mixed active/placebo strawberry powder	Mixed strawberry powder	Participants will consume a 39g mixed active/placebo strawberry powder beverage once per day for 4-weeks.

Primary Outcome Measures

Name	Time	Method
Change in plasma lipids	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 Outcome Measures

Name	Time	Method
Change in blood pressure (resting and 24-hr)	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.
Change in glucose and insulin response	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
Change in homeostatic model assessment for insulin resistance	Week 0, 4, 5, 9, 10, and 14	Calculated from fasting glucose and insulin values
Change in endothelial function	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.
Change in inflammation	Week 0, 4, 5, 9, 10, and 14	hs-CRP and IL-6 will be assessed in the fasted state from plasma
Change in arterial stiffness	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
Change in oxidixed LDL	Week 0, 4, 5, 9, 10, and 14	Obtained from blood sample in a fasted state and following consumption of a meal

Trial Locations

Locations (1)

Lafene Health Center; 🇺🇸 Manhattan, Kansas, United States