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

Purdue University

Status: Completed

Conditions: Osteoporosis

Treatments: Dietary Supplement: 10 grams SCF; Dietary Supplement: 0 grams SCF; Dietary Supplement: 20 grams SCF

Study type: Interventional

Funder types: Other

Identifiers

NCT01660503

Tate & Lyle Teen Study

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: Female

Ages: 9 to 13 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 3 patient groups, including a placebo group

No SCF

Placebo Comparator group

Description:

Twice daily consumption of snack foods containing no SCF.

Treatment:

Dietary Supplement: 0 grams SCF

10 grams SCF

Experimental group

Description:

Twice daily consumption of snack foods, each containing 5 grams SCF

Treatment:

Dietary Supplement: 10 grams SCF

20 grams SCF

Experimental group

Description:

Twice daily consumption of snack foods, each containing 10 grams SCF

Treatment:

Dietary Supplement: 20 grams SCF