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Completed

NCT Number: NCT01911390

Effect of Rice Bran and Cooked Navy Beans on Cholesterol Levels in Healthy Children

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.

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Key information

Conditions

Hyperlipidemias Dyslipidemias Hypercholesterolemia Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

8 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Colorado State University, Fort Collins, Colorado, United States

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About this study

Children will be screened prior to participation with the expectation of enrolling 40 to randomize equally to either the control arm or one of the three intervention arms. This should assure that at least 10 participants would complete each intervention. The four groups are placebo (no bean powder or rice bran included), 1/4 cup cooked navy bean powder (17.5grams powder)/day, 15 grams rice bran/day, and combination of 9 grams of bean powder/day and 8 grams rice bran/day. Participants will follow this dietary intervention by being provided a study snack, such as a banana nut muffin and strawberry-pineapple smoothie. Participants will consume one snack on a daily basis for a total of four weeks (28 days). The snack options were developed by a professional chef and research dietitian to fit a set of requirements for calorie and macronutrient content based on USDA food guide recommendations. The placebo group will be provided the same snacks without the inclusion of rice bran or bean powder.

Randomization of subjects to the dietary intervention groups will be done during the study enrollment period. Randomization will be based on sex of the subject to include equal numbers of both genders across all 4 groups.

All participants will consume the allocated foods daily for a total of four weeks (28 days) and will not be required to alter the rest of their diets in any other way. They will also complete a 3-day food and activity log each week, starting the week prior to the study intervention (Week 0) and ending the week of their final visit (Week 4).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Bean powder

Dietary Supplement

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

Rice Bran

Dietary Supplement

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

Control arm

Dietary Supplement

No bean or rice bran additive in smoothie or muffin.

Other names: Placebo Comparator

Bean powder and rice bran

Dietary 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.

Other names: Bean Powder & Rice Bran

Primary outcomes

  1. Total Cholesterol

    Time frame: Baseline, 4 weeks

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

Secondary outcomes

  1. Palatability

    Time frame: Baseline, 4 weeks

    Other outcomes include palatability and acceptability of study-provided snacks that include cooked navy bean powder, rice bran, or a combination in children. The participants will fill out questionaires describing how the products tasted and how much they consumed.

Sponsors and collaborators

Lead sponsor

Poudre Valley Health System

Other

Collaborators

  • Colorado State University

Registry information

Official study title

Effect of Rice Bran and Cooked Navy Beans on Cholesterol Levels in Healthy Children Involved in the Healthy Hearts Program

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jul 30, 2013
Registry last updated
May 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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