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

Primary Purpose

Osteoporosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
0 grams SCF
10 grams SCF
20 grams SCF
Sponsored by
Purdue University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis focused on measuring Calcium absorption, Osteoporosis, Bone Health, Adolescent

Eligibility Criteria

9 Years - 13 Years (Child)FemaleAccepts 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

Sites / Locations

  • Purdue University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

No SCF

10 grams SCF

20 grams SCF

Arm Description

Twice daily consumption of snack foods containing no SCF.

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 6, 2012
Last Updated
May 2, 2018
Sponsor
Purdue University
Collaborators
Tate and Lyle Ingredients Americas LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01660503
Brief Title
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

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2012 (Actual)
Primary Completion Date
April 30, 2014 (Actual)
Study Completion Date
April 30, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Purdue University
Collaborators
Tate and Lyle Ingredients Americas LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Calcium absorption, Osteoporosis, Bone Health, Adolescent

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No SCF
Arm Type
Placebo Comparator
Arm Description
Twice daily consumption of snack foods containing no SCF.
Arm Title
10 grams SCF
Arm Type
Experimental
Arm Description
Twice daily consumption of snack foods, each containing 5 grams SCF
Arm Title
20 grams SCF
Arm Type
Experimental
Arm Description
Twice daily consumption of snack foods, each containing 10 grams SCF
Intervention Type
Dietary Supplement
Intervention Name(s)
0 grams SCF
Intervention Description
Given in snack foods (muffins and flavored beverage)
Intervention Type
Dietary Supplement
Intervention Name(s)
10 grams SCF
Intervention Description
Given in snack foods (muffins and flavored beverage)
Intervention Type
Dietary Supplement
Intervention Name(s)
20 grams SCF
Intervention Description
Given in snack foods (muffins and flavored beverage)
Primary Outcome Measure Information:
Title
Calcium Absorption
Description
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.
Time Frame
4 Weeks
Secondary Outcome Measure Information:
Title
GI microbial changes
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Connie M Weaver, Ph.D.
Organizational Affiliation
Purdue University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Berdine R Martin, PhD
Organizational Affiliation
Purdue University
Official's Role
Study Director
Facility Information:
Facility Name
Purdue University
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47907
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27281813
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.
Results Reference
derived

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

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