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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01660503
• Other study ID #: Tate & Lyle Teen Study
• Status: Completed
• Phase: N/A
• Start date: June 1, 2012
• Est. completion date: April 30, 2014

Study information

• Verified date: May 2018
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 30, 2014
• Est. primary completion date: April 30, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 9 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Dietary Supplement:
• 0 grams SCF
Given in snack foods (muffins and flavored beverage)
• 10 grams SCF
Given in snack foods (muffins and flavored beverage)
• 20 grams SCF
Given in snack foods (muffins and flavored beverage)

Locations

Country	Name	City	State
United States	Purdue University	West Lafayette	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Purdue University	Tate and Lyle Ingredients Americas LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 Weeks
Secondary	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.	4 weeks