NCT01911390

Brief Summary

A multidisciplinary team of clinicians and researchers will conduct a pilot feasibility study to evaluate whether dietary intake of dry bean powder or rice bran or a combination is a helpful dietary recommendation to reduce total cholesterol levels in children with identified, modifiable CVD risk factors, elevated total cholesterol and obesity. Consumption of dry bean powder and rice bran merit additional investigation to study feasibility and acceptability in children and how they influence their lipid levels or obesity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

July 1, 2013

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 30, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
5 months until next milestone

Results Posted

Study results publicly available

April 5, 2017

Completed
Last Updated

May 15, 2017

Status Verified

May 1, 2017

Enrollment Period

3.3 years

First QC Date

July 25, 2013

Results QC Date

December 30, 2016

Last Update Submit

May 12, 2017

Conditions

Hyperlipidemias

Keywords

High cholesterol.

Outcome Measures

Primary Outcomes (1)

  • Total Cholesterol

    The primary outcome variable to be studied is total cholesterol. A full lipid panel report will also provide information on LDL, HDL, triglycerides etc.

    Baseline, 4 weeks

Secondary Outcomes (1)

  • Palatability

    Baseline, 4 weeks

Study Arms (4)

Control Arm

PLACEBO COMPARATOR

No bean or rice bran additive in smoothie or muffin.

Dietary Supplement: Control arm

Bean powder

ACTIVE COMPARATOR

1/4 cup beans (17.5 grams powder)/day in smoothie or muffin.

Dietary Supplement: Bean powder

Rice bran

ACTIVE COMPARATOR

15 grams rice bran/day in smoothie or muffin.

Dietary Supplement: Rice bran

Bean powder and rice bran

ACTIVE COMPARATOR

9 grams bean powder/day and 8 grams rice bran /day in smoothie or muffin.

Dietary Supplement: Bean powder and rice bran

Interventions

Bean powderDIETARY_SUPPLEMENT

Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders.

Bean powder
Rice branDIETARY_SUPPLEMENT

USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties.

Rice bran
Control armDIETARY_SUPPLEMENT

No bean or rice bran additive in smoothie or muffin.

Also known as: Placebo Comparator
Control Arm
Bean powder and rice branDIETARY_SUPPLEMENT

Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders. USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties.

Also known as: Bean Powder & Rice Bran
Bean powder and rice bran

Eligibility Criteria

Age8 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children between the ages of 8-13 years old who were screened by the Healthy Hearts Club
  • Non-fasting total cholesterol greater than or equal to 180 mg/dl
  • Non-fasting LDL greater than or equal to 100mg/dl
  • Non-fasting HDL less than 60mg/dl
  • Willing to consume study provided ingredient (cooked dry bean powder or rice bran or combination) for 28 consecutive days.

You may not qualify if:

  • History of food allergies and/or major dietary restrictions
  • Taking prescribed medication
  • Ongoing medical illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Colorado State University

Fort Collins, Colorado, 80523, United States

Location

Medical Center of the Rockies

Loveland, Colorado, 80538, United States

Location

Related Publications (1)

  • Li KJ, Borresen EC, Jenkins-Puccetti N, Luckasen G, Ryan EP. Navy Bean and Rice Bran Intake Alters the Plasma Metabolome of Children at Risk for Cardiovascular Disease. Front Nutr. 2018 Jan 19;4:71. doi: 10.3389/fnut.2017.00071. eCollection 2017.

    PMID: 29404331DERIVED

MeSH Terms

Conditions

HyperlipidemiasHypercholesterolemia

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Results Point of Contact

Title
Dr Elizabeth Ryan
Organization
Department of Environmental and Radiological Health Sciences
E.P.Ryan@colostate.du
970-491-1536

Study Officials

  • Elizabeth Ryan, PhD

    Colorado State University

    PRINCIPAL INVESTIGATOR

  • Gary Luckasen, MD

    University of Colorado Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-Principal Investigator

Study Record Dates

First Submitted

July 25, 2013

First Posted

July 30, 2013

Study Start

July 1, 2013

Primary Completion

October 1, 2016

Study Completion

November 1, 2016

Last Updated

May 15, 2017

Results First Posted

April 5, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

US(2)