Trial record 5 of 26 for:    bone health, calcium, osteoporosis | Child

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Tate and Lyle Ingredients Americas LLC
Information provided by (Responsible Party):
Berdine Martin, Purdue University
ClinicalTrials.gov Identifier:
NCT01660503
First received: August 6, 2012
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention
Osteoporosis
Dietary Supplement: 0 grams SCF
Dietary Supplement: 10 grams SCF
Dietary Supplement: 20 grams SCF

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Dose Response Effects of Soluble Corn Fiber (SCF) on Calcium Metabolism and Gastrointestinal Microflora in Adolescents

Resource links provided by NLM:


Further study details as provided by Purdue University:

Primary Outcome Measures:
  • Calcium Absorption [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • GI microbial changes [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: June 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: No SCF
Twice daily consumption of snack foods containing no SCF.
Dietary Supplement: 0 grams SCF
Given in snack foods (muffins and flavored beverage)
Experimental: 10 grams SCF
Twice daily consumption of snack foods, each containing 5 grams SCF
Dietary Supplement: 10 grams SCF
Given in snack foods (muffins and flavored beverage)
Experimental: 20 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)

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

Ages Eligible for Study:   9 Years to 13 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01660503

Locations
United States, Indiana
Purdue University
West Lafayette, Indiana, United States, 47907
Sponsors and Collaborators
Purdue University
Tate and Lyle Ingredients Americas LLC
Investigators
Principal Investigator: Connie M Weaver, Ph.D. Purdue University
Study Director: Berdine R Martin, PhD Purdue University
  More Information

No publications provided

Responsible Party: Berdine Martin, Research Scientist, Nutrition Science, Purdue University
ClinicalTrials.gov Identifier: NCT01660503     History of Changes
Other Study ID Numbers: Tate & Lyle Teen Study
Study First Received: August 6, 2012
Last Updated: March 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Purdue University:
Calcium absorption
Osteoporosis
Bone Health
Adolescent

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 19, 2014