Dose Effects of SCF on Calcium Metabolism and GI Microflora in Adolescents

May 2, 2018 updated by: Berdine Martin, Purdue University

Dose Response Effects of Soluble Corn Fiber (SCF) on Calcium Metabolism and Gastrointestinal Microflora in Adolescents

Soluble corn fiber (SCF) has been shown to enhance calcium utilization and bone properties in rats and in adolescent boys and girls.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The growing knowledge of non-digestible oligosaccharide (NDO)-related health benefits has led to the identification of other fermentable carbohydrates which may improve bone balance and bone health parameters. One such carbohydrate is the corn derivative, soluble corn fiber (SCF). Already known for its association with improved intestinal health and influence on colonic microflora content, we have been studying the effects of SCF on calcium absorption and bone health. First we found that soluble corn fiber (SCF) greatly enhanced calcium utilization and bone properties in a growing rat model. Results from this study demonstrated that SCF was capable of increasing bone mineral content, density and bone strength parameters in 4-week old, male rats. Our study in adolescent boys and girls showed a 12% increase in calcium absorption after consuming 12 g SCF for 21 days compared to a control period in a crossover design using a controlled feeding metabolic balance approach. Given these profound changes on calcium absorption and in bone, a logical next step is to study a dose-response effect of SCF on calcium absorption, bone turnover, and gut microflora in free-living adolescents.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • West Lafayette, Indiana, United States, 47907
        • Purdue University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 13 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy adolescent Caucasian girls between the ages of 12-14. This population has been chosen because they exhibit higher risk for osteoporosis later in life.

Exclusion Criteria:

  • Habitual dietary patterns including less than 550 and greater than 1500 mg Ca per day. This represents the 5th and 95th percentile of usual intake of girls 9-13 y in the US.
  • History of smoking, alcohol use, illegal or non-prescription drug use
  • History of disordered calcium or bone metabolism e.g. Paget's disease, hyper or hypo-calcemia
  • History of gastrointestinal diseases (Crohn's, celiac, inflammatory bowel disease)
  • History of diseases that affect kidney or liver function.
  • Body Mass Index (BMI) less than 5th percentile for age or greater than the 90th percentile for age
  • Having a broken bone within the last 6 months.
  • Regular consumption of foods or supplements containing prebiotics or probiotics
  • History of pregnancy or use of contraceptives

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: No SCF
Twice daily consumption of snack foods containing no SCF.
Dietary supplement: 0 grams SCF
Given in snack foods (muffins and flavored beverage)
Experimental: 10 grams SCF
Twice daily consumption of snack foods, each containing 5 grams SCF
Dietary supplement: 10 grams SCF
Given in snack foods (muffins and flavored beverage)
Experimental: 20 grams SCF
Twice daily consumption of snack foods, each containing 10 grams SCF
Dietary supplement: 20 grams SCF
Given in snack foods (muffins and flavored beverage)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Calcium Absorption
Time Frame: 4 Weeks

The subject will be asked to consume one snack item in the morning and one snack in the evening for four consecutive weeks.

After consuming the SCF product for four weeks the teen will come to Purdue University campus for 3 nights and days (e.g. Thursday noon - Sunday noon). They will reside in university residence hall or hotel near campus. Calcium Absorption testing will be done utilizing 43Ca and 44Ca.
4 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GI microbial changes
Time Frame: 4 weeks
Fecal microbial analyses will be performed on a baseline sample collected before each 4 week consumption period to establish basal microbial profiles. Additional analyses will be performed on fecal samples collected during the 3 day clinical visit to compare microbial changes in response to SCF treatments.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Purdue University

Collaborators

Tate and Lyle Ingredients Americas LLC

Investigators

  • Study Director: Berdine R Martin, PhD, Purdue University
  • Principal Investigator: Connie M Weaver, Ph.D., Purdue University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2012

Primary Completion (Actual)

April 30, 2014

Study Completion (Actual)

April 30, 2014

Study Registration Dates

First Submitted

August 6, 2012

First Submitted That Met QC Criteria

August 6, 2012

First Posted (Estimate)

August 8, 2012

Study Record Updates

Last Update Posted (Actual)

May 4, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tate & Lyle Teen Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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