An interventional study of 0 grams SCF and 10 grams SCF in Osteoporosis, sponsored by Purdue University. Completed at 1 site in United States. Open to female participants aged 9 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-04.
Sponsored by Purdue University · Not applicable, Interventional, and Prevention
Soluble corn fiber (SCF) has been shown to enhance calcium utilization and bone properties in rats and in adolescent boys and girls.
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.
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's enrollment of 30 is below the median of 95 across 1,133 interventional studies indexed under Osteoporosis.
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Exclusion Criteria:
Twice daily consumption of snack foods containing no SCF.
Dietary Supplement: 0 grams SCF
Twice daily consumption of snack foods, each containing 5 grams SCF
Dietary Supplement: 10 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)
Given in snack foods (muffins and flavored beverage)
Given in snack foods (muffins and flavored beverage)
Calcium Absorption
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.
Time frame: 4 Weeks
GI microbial changes
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.
Time frame: 4 weeks
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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