This trial is active, not recruiting.

Condition osteoporosis
Treatments 0 grams scf, 10 grams scf, 20 grams scf
Sponsor Purdue University
Collaborator Tate and Lyle Ingredients Americas LLC
Start date June 2012
End date April 2014
Trial size 30 participants
Trial identifier NCT01660503, Tate & Lyle Teen Study


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics study
Intervention model crossover assignment
Masking double blind (subject, investigator)
Primary purpose prevention
(Placebo Comparator)
Twice daily consumption of snack foods containing no SCF.
0 grams scf
Given in snack foods (muffins and flavored beverage)
Twice daily consumption of snack foods, each containing 5 grams SCF
10 grams scf
Given in snack foods (muffins and flavored beverage)
Twice daily consumption of snack foods, each containing 10 grams SCF
20 grams scf
Given in snack foods (muffins and flavored beverage)

Primary Outcomes

Calcium Absorption
time frame: 4 Weeks

Secondary Outcomes

GI microbial changes
time frame: 4 weeks

Eligibility Criteria

Female participants from 9 years up to 13 years old.

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

Additional Information

Official title Dose Response Effects of Soluble Corn Fiber (SCF) on Calcium Metabolism and Gastrointestinal Microflora in Adolescents
Principal investigator Connie M Weaver, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Purdue University.