View Clinical Trial (Medical Research Study)
Dose Response Effects of Soluble Corn Fiber (SCF) on Calcium Metabolism and Gastrointestinal Microflora in Adolescents
| City: |
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West Lafayette |
| State: |
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Indiana |
| Zip Code: |
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47907 |
| Conditions: |
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Osteoporosis |
| Purpose: |
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Soluble corn fiber (SCF) has been shown to enhance calcium utilization and bone properties
in rats and in adolescent boys and girls.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT01660503 |
| Primary Contact: |
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Principal Investigator
Connie M Weaver, Ph.D.
Purdue University
Berdine R Martin, Ph.D.
Phone: 765-494-6559
Email: bmartin1@purdue.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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West Lafayette, Indiana 47907
United States
Berdine R Martin, PhD
Phone: 765-494-6559
Email: bmartin1@purdue.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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