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

NCT ID: NCT01660503

Last Updated: 2018-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-01

Study Completion Date

2014-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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No SCF

Twice daily consumption of snack foods containing no SCF.

Group Type PLACEBO_COMPARATOR

0 grams SCF

Intervention Type DIETARY_SUPPLEMENT

Given in snack foods (muffins and flavored beverage)

10 grams SCF

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

Group Type EXPERIMENTAL

10 grams SCF

Intervention Type DIETARY_SUPPLEMENT

Given in snack foods (muffins and flavored beverage)

20 grams SCF

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

Group Type EXPERIMENTAL

20 grams SCF

Intervention Type DIETARY_SUPPLEMENT

Given in snack foods (muffins and flavored beverage)

Interventions

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0 grams SCF

Given in snack foods (muffins and flavored beverage)

Intervention Type DIETARY_SUPPLEMENT

10 grams SCF

Given in snack foods (muffins and flavored beverage)

Intervention Type DIETARY_SUPPLEMENT

20 grams SCF

Given in snack foods (muffins and flavored beverage)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

9 Years

Maximum Eligible Age

13 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Tate and Lyle Ingredients Americas LLC

UNKNOWN

Sponsor Role collaborator

Purdue University

OTHER

Sponsor Role lead

Responsible Party

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Berdine Martin

Research Scientist, Nutrition Science

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Connie M Weaver, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Purdue University

Berdine R Martin, PhD

Role: STUDY_DIRECTOR

Purdue University

Locations

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Purdue University

West Lafayette, Indiana, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 27281813 (View on PubMed)

Other Identifiers

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Tate & Lyle Teen Study

Identifier Type: -

Identifier Source: org_study_id

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