NCT02557334

Brief Summary

The purpose of this study is to evaluate the effects of freeze dried strawberry powder on LDL cholesterol, central and peripheral blood pressure, indices of arterial stiffness, and other lipid and lipoprotein concentrations. The investigators hypothesize that the bioactive compounds in freeze dried strawberry powder may elicit beneficial effects on LDL cholesterol, as well as blood pressure and arterial health.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

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 18, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 23, 2015

Completed
8 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

August 18, 2023

Status Verified

August 1, 2023

Enrollment Period

3.6 years

First QC Date

September 18, 2015

Last Update Submit

August 15, 2023

Conditions

Cardiovascular Disease

Keywords

Strawberry PowderCardiovascular Disease Risk Factors

Outcome Measures

Primary Outcomes (1)

  • LDL-C

    LDL-C values calculated using the Friedewald equation

    Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage

Secondary Outcomes (10)

  • Central Blood Pressure

    Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage

  • Peripheral Blood Pressure

    Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage

  • Augmentation Index

    Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage

  • Pulse Wave Velocity

    Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage

  • Total Cholesterol

    Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage

  • +5 more secondary outcomes

Study Arms (3)

Low Dose Strawberry Powder

EXPERIMENTAL

40 g composed of 13 g freeze dried strawberry powder + 27 g placebo powder

Dietary Supplement: Low Dose Strawberry Powder

High Dose Strawberry Powder

EXPERIMENTAL

40 g freeze dried strawberry powder

Dietary Supplement: High Dose Strawberry Powder

Placebo Powder

PLACEBO COMPARATOR

40 g color and taste matched placebo powder

Dietary Supplement: Placebo Powder

Interventions

Low Dose Strawberry PowderDIETARY_SUPPLEMENT

40 g composed of 13 g freeze dried strawberry powder + 27 g placebo powder

Low Dose Strawberry Powder
High Dose Strawberry PowderDIETARY_SUPPLEMENT

40 g freeze dried strawberry powder

High Dose Strawberry Powder
Placebo PowderDIETARY_SUPPLEMENT

40 g color and taste matched placebo powder

Placebo Powder

Eligibility Criteria

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

You may qualify if:

  • Men and women 35-65 years of age
  • BMI ≥ 25 and ≤ 39 kg/m\^2
  • LDL-C \> 116 mg/dL
  • Total Cholesterol below 273 mg/dL for men and below 284 mg/dL for women
  • Triglycerides below 350 mg/d
  • Non-smokers
  • Blood pressure \< 160/100 mmHg

You may not qualify if:

  • History of acute or chronic inflammatory conditions or heart disease, kidney disease, liver disease, autoimmune disorders, or thyroid disease (unless controlled by medication and blood results within the previous 6 months are provided)
  • History of diabetes mellitus (and/or a fasting glucose \> 126 mg/dL at screening)
  • Stage II hypertension (blood pressure ≥ 160/100 mmHg)
  • Lactation, pregnancy, or desire to become pregnant during the study
  • Unwillingness to discontinue nutritional supplements, herbs, or vitamins, unless approved by investigator
  • Use of medications/supplements for elevated lipids, blood pressure, or glucose
  • Chronic use of non-steroidal anti-inflammatory or immunosuppressant medication
  • Conditions requiring the use of steroids
  • Unwillingness to refrain from blood donation prior to and during the study
  • Any medical condition or abnormal laboratory value that is judged clinically significant by an investigator
  • Allergy or sensitivity to strawberries or any ingredient in the study powders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State CRC

University Park, Pennsylvania, 16803, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Penny Kris-Etherton, PhD, RD

    Penn State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2015

First Posted

September 23, 2015

Study Start

October 1, 2015

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

August 18, 2023

Record last verified: 2023-08

Locations

US(1)