Strawberry Consumption in Overweight and Obese Individuals

Obesity Clinical Trial

Official title:

Integrated Cardiovascular and Metabolic Effects of Strawberry Consumption in Overweight and Obese Individuals

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04094103
• Other study ID #: Pro9736
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2022
• Source: Kansas State University
• Contact: Sara Rosenkranz, PhD
• Phone: 785-532-5508
• Email: sararose[@]ksu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Metabolic Syndrome
• Obesity
• Overweight

Intervention

Dietary Supplement:
• Active strawberry powder
Participants will drink a strawberry beverage with active ingredients once a day during the 4-week intervention period.
• Placebo strawberry powder
Participants will drink a strawberry placebo beverage once a day during the 4-week intervention period.
• Mixed strawberry powder
Participants will drink a mixed strawberry beverage with active ingredients and placebo once a day during the 4-week intervention period.

Locations

Country	Name	City	State
United States	Lafene Health Center	Manhattan	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Carl Ade, M.S., Ph.D.	California Strawberry Commission

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in plasma lipids	Total cholesterol (TC), LDL-c , VLDL-c, HDL-c , triglycerides (TG) from blood sample in a fasted state and following consumption of a meal	Week 0, 4, 5, 9, 10, and 14
Secondary	Change in glucose and insulin response	Glucose, insulin, and c-peptide obtained from blood sample in a fasted state and in response to a meal	Week 0, 4, 5, 9, 10, and 14
Secondary	Change in oxidixed LDL	Obtained from blood sample in a fasted state and following consumption of a meal	Week 0, 4, 5, 9, 10, and 14
Secondary	Change in homeostatic model assessment for insulin resistance	Calculated from fasting glucose and insulin values	Week 0, 4, 5, 9, 10, and 14
Secondary	Change in inflammation	hs-CRP and IL-6 will be assessed in the fasted state from plasma	Week 0, 4, 5, 9, 10, and 14
Secondary	Change in arterial stiffness	Determined via changes in carotid artery stiffness calculated from simultaneous measurements of carotid artery diameter and pressure-waveforms	Week 0, 4, 5, 9, 10, and 14
Secondary	Change in blood pressure (resting and 24-hr)	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.	Week 0, 4, 5, 9, 10, and 14
Secondary	Change in endothelial function	Flow mediated dilation (FMD) assessed via a non-invasive 2D Doppler ultrasound following a 5-min period of arterial occlusion.	Week 0, 4, 5, 9, 10, and 14