Clinical trial NCT01660503: Dose Effects of SCF on Calcium Metabolism and GI Microflora in Adolescents
Official title: Dose Response Effects of Soluble Corn Fiber (SCF) on Calcium Metabolism and Gastrointestinal Microflora in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Keywords: Calcium absorption
Osteoporosis
Bone Health
Adolescent
Lead sponsor: Purdue University
Sponsor class: OTHER
Collaborators: name: Tate and Lyle Ingredients Americas LLC
First posted: 2012-08-08
Enrollment: 30
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Calcium Absorption
timeFrame: 4 Weeks
Secondary outcomes:
measure: GI microbial changes
timeFrame: 4 weeks
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
affiliation: Purdue University
name: Connie M Weaver, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Purdue University
name: Berdine R Martin, PhD
role: STUDY_DIRECTOR
References:
citation: Whisner CM, Martin BR, Nakatsu CH, Story JA, MacDonald-Clarke CJ, McCabe LD, McCabe GP, Weaver CM. Soluble Corn Fiber Increases Calcium Absorption Associated with Shifts in the Gut Microbiome: A Randomized Dose-Response Trial in Free-Living Pubertal Females. J Nutr. 2016 Jul;146(7):1298-306. doi: 10.3945/jn.115.227256. Epub 2016 Jun 8.