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Strawberry Consumption in Overweight and Obese Individuals

Primary Purpose

Obesity, Metabolic Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active strawberry powder
Placebo strawberry powder
Mixed strawberry powder
Sponsored by
Carl Ade, M.S., Ph.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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)

Sites / Locations

  • Lafene Health CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Active strawberry powder

Placebo strawberry powder

Mixed active/placebo strawberry powder

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Change in oxidixed LDL
Obtained from blood sample in a fasted state and following consumption of a meal
Change in homeostatic model assessment for insulin resistance
Calculated from fasting glucose and insulin values
Change in inflammation
hs-CRP and IL-6 will be assessed in the fasted state from plasma
Change in arterial stiffness
Determined via changes in carotid artery stiffness calculated from simultaneous measurements of carotid artery diameter and pressure-waveforms
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.
Change in endothelial function
Flow mediated dilation (FMD) assessed via a non-invasive 2D Doppler ultrasound following a 5-min period of arterial occlusion.

Full Information

First Posted
September 13, 2019
Last Updated
March 30, 2022
Sponsor
Carl Ade, M.S., Ph.D.
Collaborators
California Strawberry Commission
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1. Study Identification

Unique Protocol Identification Number
NCT04094103
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Carl Ade, M.S., Ph.D.
Collaborators
California Strawberry Commission

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Metabolic Syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Masking Description
The supplement and placebo will be distributed to the individual by a member of the research team who is not involved with data collection or analysis.
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active strawberry powder
Arm Type
Experimental
Arm Description
Participants will consume a 39g freeze-dried active strawberry powder beverage once per day for 4-weeks.
Arm Title
Placebo strawberry powder
Arm Type
Placebo Comparator
Arm Description
Participants will consume a 39g freeze-dried strawberry powder placebo beverage once per day for 4-weeks.
Arm Title
Mixed active/placebo strawberry powder
Arm Type
Active Comparator
Arm Description
Participants will consume a 39g mixed active/placebo strawberry powder beverage once per day for 4-weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Active strawberry powder
Intervention Description
Participants will drink a strawberry beverage with active ingredients once a day during the 4-week intervention period.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo strawberry powder
Intervention Description
Participants will drink a strawberry placebo beverage once a day during the 4-week intervention period.
Intervention Type
Dietary Supplement
Intervention Name(s)
Mixed strawberry powder
Intervention Description
Participants will drink a mixed strawberry beverage with active ingredients and placebo once a day during the 4-week intervention period.
Primary Outcome Measure Information:
Title
Change in plasma lipids
Description
Total cholesterol (TC), LDL-c , VLDL-c, HDL-c , triglycerides (TG) from blood sample in a fasted state and following consumption of a meal
Time Frame
Week 0, 4, 5, 9, 10, and 14
Secondary Outcome Measure Information:
Title
Change in glucose and insulin response
Description
Glucose, insulin, and c-peptide obtained from blood sample in a fasted state and in response to a meal
Time Frame
Week 0, 4, 5, 9, 10, and 14
Title
Change in oxidixed LDL
Description
Obtained from blood sample in a fasted state and following consumption of a meal
Time Frame
Week 0, 4, 5, 9, 10, and 14
Title
Change in homeostatic model assessment for insulin resistance
Description
Calculated from fasting glucose and insulin values
Time Frame
Week 0, 4, 5, 9, 10, and 14
Title
Change in inflammation
Description
hs-CRP and IL-6 will be assessed in the fasted state from plasma
Time Frame
Week 0, 4, 5, 9, 10, and 14
Title
Change in arterial stiffness
Description
Determined via changes in carotid artery stiffness calculated from simultaneous measurements of carotid artery diameter and pressure-waveforms
Time Frame
Week 0, 4, 5, 9, 10, and 14
Title
Change in blood pressure (resting and 24-hr)
Description
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.
Time Frame
Week 0, 4, 5, 9, 10, and 14
Title
Change in endothelial function
Description
Flow mediated dilation (FMD) assessed via a non-invasive 2D Doppler ultrasound following a 5-min period of arterial occlusion.
Time Frame
Week 0, 4, 5, 9, 10, and 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Rosenkranz, PhD
Phone
785-532-5508
Email
sararose@ksu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Rosenkranz, PhD
Organizational Affiliation
Kansas State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lafene Health Center
City
Manhattan
State/Province
Kansas
ZIP/Postal Code
66502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Rosenkranz, Ph.D.
Phone
785-532-5508
Email
sararose@ksu.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Strawberry Consumption in Overweight and Obese Individuals

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