NCT04094103

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 18, 2019

Completed
13 days until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2023

Completed
Last Updated

September 2, 2025

Status Verified

August 1, 2025

Enrollment Period

4.1 years

First QC Date

September 13, 2019

Last Update Submit

August 25, 2025

Conditions

ObesityMetabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Change in glucose and insulin response

    Week 0, 4, 5, 9, 10, and 14

  • Change in oxidixed LDL

    Week 0, 4, 5, 9, 10, and 14

  • Change in homeostatic model assessment for insulin resistance

    Week 0, 4, 5, 9, 10, and 14

  • Change in inflammation

    Week 0, 4, 5, 9, 10, and 14

  • Change in arterial stiffness

    Week 0, 4, 5, 9, 10, and 14

  • +2 more secondary outcomes

Study Arms (3)

Active strawberry powder

EXPERIMENTAL

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

Dietary Supplement: Active strawberry powder

Placebo strawberry powder

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo strawberry powder

Mixed active/placebo strawberry powder

ACTIVE COMPARATOR

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

Dietary Supplement: Mixed strawberry powder

Interventions

Active strawberry powderDIETARY_SUPPLEMENT

Participants will drink a strawberry beverage with active ingredients once a day during the 4-week intervention period.

Active strawberry powder
Placebo strawberry powderDIETARY_SUPPLEMENT

Participants will drink a strawberry placebo beverage once a day during the 4-week intervention period.

Placebo strawberry powder
Mixed strawberry powderDIETARY_SUPPLEMENT

Participants will drink a mixed strawberry beverage with active ingredients and placebo once a day during the 4-week intervention period.

Mixed active/placebo strawberry powder

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Overweight or obese by BMI (25.0-34.9kg/m2),
  • Borderline-high LDL-cholesterol (130-159mg/dL),
  • Normal or elevated blood pressure ((≤129mmHg/≤80mmHg)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lafene Health Center

Manhattan, Kansas, 66502, United States

Location

MeSH Terms

Conditions

ObesityMetabolic Syndrome

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Sara Rosenkranz, PhD

    Kansas State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Co-Principal Investigator

Study Record Dates

First Submitted

September 13, 2019

First Posted

September 18, 2019

Study Start

October 1, 2019

Primary Completion

October 27, 2023

Study Completion

October 27, 2023

Last Updated

September 2, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)