NCT03441620

Brief Summary

In this study, we propose to investigate the effects of dietary achievable doses of strawberries on serum LDL-cholesterol (LDL-C) and related lipid profiles, measures of glycemia and insulin resistance, and biomarkers of inflammation in a 14 week controlled crossover study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

March 16, 2021

Status Verified

March 1, 2021

Enrollment Period

3 years

First QC Date

February 5, 2018

Last Update Submit

March 12, 2021

Conditions

Hyper-LDL-cholesterolemiaMetabolic Syndrome

Outcome Measures

Primary Outcomes (4)

  • Serum Lipid profiles

    Serum LDL, total and HDL cholesterol, triglycerides

    14 weeks

  • Glycemic control

    Blood glucose

    14 weeks

  • Serum lipid particle concentrations

    Molar concentrations of serum lipids and particle size

    14 weeks

  • Diabetes control

    Insulin resistance

    14 weeks

Secondary Outcomes (3)

  • Systemic Inflammation

    14 weeks

  • Systemic Anthocyanins

    14 weeks

  • Serum metabolomics

    14 weeks

Study Arms (3)

Control

PLACEBO COMPARATOR

Calorie and fiber-matched control powder

Other: Control powder

Strawberry one serving

EXPERIMENTAL

Freeze-dried powder equivalent to one serving fresh strawberries per day.

Dietary Supplement: strawberries

Strawberry two-half servings

EXPERIMENTAL

Freeze-dried powder equivalent to 2.5 serving fresh strawberries per day.

Dietary Supplement: strawberries

Interventions

strawberriesDIETARY_SUPPLEMENT

Freeze-dried strawberry powder

Strawberry one servingStrawberry two-half servings
Control powderOTHER

Control powder matched for fiber and strawberries

Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elevated total and LDL cholesterol (\>116 mg/dL)
  • body mass index (\> or = 30 kg/m2)
  • features of the metabolic syndrome

You may not qualify if:

  • taking glucose and lipid lowering medications (e.g. statins, metformin)
  • history of chronic conditions (diabetes, CHD, anemia, renal diseases)
  • allergic to strawberries
  • pregnant and/or lactating
  • smoking
  • vegetarian or consuming special diet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Nevada at Las Vegas

Las Vegas, Nevada, 89154, United States

Location

University of Oklahoma Health Sciences Center, OCTSI

Oklahoma City, Oklahoma, 73104, United States

Location

Oklahoma State University

Stillwater, Oklahoma, 74078, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Arpita Basu, PHD

    University of Nevada at Las Vegas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 5, 2018

First Posted

February 22, 2018

Study Start

February 1, 2018

Primary Completion

January 31, 2021

Study Completion

January 31, 2021

Last Updated

March 16, 2021

Record last verified: 2021-03

Locations

US(3)