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Effect of Soluble Corn Fiber Supplementation for 1 Year on Bone Metabolism in Adolescents

Primary Purpose

Osteoporosis

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Soluble Corn Fiber (SCF) without Calcium
Soluble Corn Fiber (SCF) + Calcium
Placebo
Placebo + calcium
Sponsored by
Florida International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis focused on measuring fiber, calcium absorption, bone mass, adolescents

Eligibility Criteria

9 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Body mass index between the 5th and 85th percentiles for age and sex based on the Centers for Disease Control Growth Charts.

Exclusion Criteria:

  • Subjects with any chronic illness requiring regular medication use.
  • Those taking calcium supplements (>500 mg/d) and vitamin D supplements (>400 IU/d) on a regular basis

Sites / Locations

  • Nicklaus Childrens HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Placebo Comparator

Arm Label

Soluble Corn Fiber (SCF) + Calcium

Soluble Corn Fiber (SCF) without calcium

Placebo

Placebo + calcium

Arm Description

This group will receive 12 g/d of soluble corn fiber (SCF) + 600 mg/d of elemental calcium carbonate, administered twice a day

This group will receive 12 g/d of soluble corn fiber (SCF) + 600 mg/d of elemental calcium carbonate, administered twice a day

This group will receive a similar supplement without SCF or calcium, administered twice a day

This group will receive a similar supplement without SCF + 600 mg/d of elemental calcium carbonate, administered twice a day

Outcomes

Primary Outcome Measures

Change in bone mineral content (BMC)
Participants will undergo a bone scan at baseline, at 6 months and at 12-months follow-up visits using a dual energy x-ray absorptiometry (DXA)
Change in total bone mineral density (BMD)-z score
Participants will undergo a bone scan at baseline, at 6 months and at 12-months follow-up visits using a dual energy x-ray absorptiometry (DXA)

Secondary Outcome Measures

Change in vitamin D status
Vitamin D status will be measured as serum 25(OH)D at baseline and 12-months follow-up visits using standard ELISA kits.
Change in serum calcium
Serum calcium will be measured at baseline and 12-months follow-up visits using standardized kits
Change in serum phosphate
It will be measured at baseline and 12-months follow-up visits from a serum sample using standardized kits
Change in bone alkaline phosphatase
It will be measured at baseline and 12-months follow-up visits from a serum sample using standardized kits
Change in parathyroid hormone (PTH)
It will be measured at baseline and 12-months follow-up visits from a serum sample using standardized kits
Change in osteocalcin
It will be measured at baseline and 12-months follow-up visits from a serum sample using standardized kits
Change in bone specific alkaline phosphatase
It will be measured at baseline and 12-months follow-up visits from a serum sample using standardized kits
Change in serum creatinine
It will be measured at baseline and 12-months follow-up visits from a serum sample using standardized kits
Change in serum carboxy-terminal collagen crosslinks (CTX)
I will be measured at baseline and 12-months follow-up visits using standardized kits
Change in serum insulin growth factor 1 (IGF-I).
It will be measured at baseline and 12-months follow-up visits from a serum sample using standardized kits
Change in urinary calcium
It will be measured at baseline and 12-months follow-up visits from a 24-h urine sample using standardized kits
Change in urinary phosphorus
It will be measured at baseline and 12-months follow-up visits from a 24-h urine sample using standardized kits
Change in urinary creatinine
It will be measured at baseline and 12-months follow-up visits from a 24-h urine sample using standardized kits
Change in urinary N-telopeptide cross-links
It will be measured at baseline and 12-months follow-up visits from a 24-h urine sample using standardized kits
Change in total BMD
Participants will undergo a bone scan at baseline, at 6 months and at 12-months follow-up visits using a dual energy x-ray absorptiometry (DXA)
Change in spine BMC
Participants will undergo a bone scan at baseline, at 6 months and at 12-months follow-up visits using a dual energy x-ray absorptiometry (DXA)
Change in body fat
Participants will undergo a bone scan at baseline, at 6 months and at 12-months follow-up visits using a dual energy x-ray absorptiometry (DXA)
Change in phylogenetic diversity of bacterial communities
Participants will provide a fecal sample at baseline and at 12-months follow-up visits using 16S ribosomal RNA (or 16S rRNA) gene sequences

Full Information

First Posted
August 25, 2016
Last Updated
April 12, 2023
Sponsor
Florida International University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT02916862
Brief Title
Effect of Soluble Corn Fiber Supplementation for 1 Year on Bone Metabolism in Adolescents
Official Title
Effect of Soluble Corn Fiber Supplementation for 1 Year on Bone Metabolism in Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2020 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida International University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary aim of this proposal is to determine the effects of soluble corn fiber (SCF) supplementation for 1 year on bone metabolism in growing adolescents compared to controls. For the proposed study, a randomized double-blinded placebo controlled clinical trial will be conducted in 236 healthy adolescents aged 10-13 years, equally randomly assigned to one of four intervention groups: SCF (12 g/d), SCF + calcium (12 g/d of SCF + 600 mg/d of elemental calcium), placebo (0 g/d of SCF or of calcium), and placebo + calcium (0 g/d of SCF + 600 mg/d of elemental calcium); all administered twice a day. Bone mass will be assessed at baseline at 6 months and at 12 months and bone related biomarkers and fecal microbiome will be assessed at baseline and at 12 months.
Detailed Description
The adolescent period is crucial for optimizing future bone health because bone accumulates rapidly during these years and accounts for up to half of adult peak bone mass. Calcium intake during this period is critical for adequate bone mineralization but this is the nutrient most deficient in the diets of adolescents. A strategy to maximize bone mineralization during this critical period is to increase the absorption of the calcium being consumed. This could be achieved by supplementing diets with certain non-digestible carbohydrates, such as soluble corn fiber (SCF). The primary aim of this study is to determine the effects of SCF supplementation for 1 year on bone metabolism in growing adolescents compared to controls. A randomized double-blinded placebo controlled clinical trial will be conducted in 236 healthy adolescents aged 10-13 years, equally randomly assigned to one of four intervention groups: SCF (12 g/d), SCF + calcium (12 g/d of SCF + 600 mg/d of elemental calcium), placebo (0 g/d of SCF or of calcium), and placebo + calcium (0 g/d of SCF + 600 mg/d of elemental calcium); all administered twice a day. Bone mass will be assessed at baseline at 6 months and at 12 months and bone related biomarkers and fecal microbiome will be assessed at baseline and at 12 months. The treatments will be provided in the form of flavored drinks twice per day (this was previously used in a short-term study among adolescents with excellent acceptance). Bone mass and anthropometric measurements will be assessed at baseline, at 6 months and at 12 months and bone related biomarkers and fecal microbiome will be assessed at baseline and at 12 months. Assessment visits will be conducted in the Clinical Research Center of the Stempel School of Public Health at Florida International University. We will also have short home visits at 3 and 9 months to collect unused supplements and provide more supplements. In all visits, participants will complete several questionnaires, such as general health, diet and activity questionnaire. Compliance will be evaluated at all visits and also in real time using a study mobile app. The primary outcome is change in bone mineral content (BMC) measured using Dual-energy X-ray absorptiometry (DXA) The secondary outcomes include biochemical markers reflecting vitamin D status, calcium homeostasis and bone, such as serum calcium, phosphorus, creatinine, osteocalcin, carboxy-terminal collagen crosslinks (CTX), parathyroid hormone (PTH), bone specific alkaline phosphatase, 25-(OH) vitamin D3, 1,25-(OH)2 vitamin D3, and insulin growth factor 1 (IGF-I) and urinary calcium, phosphorus, creatinine and N-telopeptide cross-links.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
fiber, calcium absorption, bone mass, adolescents

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
we are testing a fiber and calcium supplement so it is not a drug
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Soluble Corn Fiber (SCF) + Calcium
Arm Type
Experimental
Arm Description
This group will receive 12 g/d of soluble corn fiber (SCF) + 600 mg/d of elemental calcium carbonate, administered twice a day
Arm Title
Soluble Corn Fiber (SCF) without calcium
Arm Type
Active Comparator
Arm Description
This group will receive 12 g/d of soluble corn fiber (SCF) + 600 mg/d of elemental calcium carbonate, administered twice a day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
This group will receive a similar supplement without SCF or calcium, administered twice a day
Arm Title
Placebo + calcium
Arm Type
Placebo Comparator
Arm Description
This group will receive a similar supplement without SCF + 600 mg/d of elemental calcium carbonate, administered twice a day
Intervention Type
Dietary Supplement
Intervention Name(s)
Soluble Corn Fiber (SCF) without Calcium
Intervention Description
Participants will consume a supplement with 12 g/day of SCF for 12 months
Intervention Type
Combination Product
Intervention Name(s)
Soluble Corn Fiber (SCF) + Calcium
Intervention Description
Participants will consume a supplement with 12 g/day of SCF + calcium carbonate (600 mg/day) for 12 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Participants will consume a supplement without SCF or calcium carbonate for 12 months
Intervention Type
Combination Product
Intervention Name(s)
Placebo + calcium
Intervention Description
Participants will consume a supplement without SCF + calcium carbonate (600 mg/day) for 12 months
Primary Outcome Measure Information:
Title
Change in bone mineral content (BMC)
Description
Participants will undergo a bone scan at baseline, at 6 months and at 12-months follow-up visits using a dual energy x-ray absorptiometry (DXA)
Time Frame
12 months
Title
Change in total bone mineral density (BMD)-z score
Description
Participants will undergo a bone scan at baseline, at 6 months and at 12-months follow-up visits using a dual energy x-ray absorptiometry (DXA)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in vitamin D status
Description
Vitamin D status will be measured as serum 25(OH)D at baseline and 12-months follow-up visits using standard ELISA kits.
Time Frame
12 months
Title
Change in serum calcium
Description
Serum calcium will be measured at baseline and 12-months follow-up visits using standardized kits
Time Frame
12 months
Title
Change in serum phosphate
Description
It will be measured at baseline and 12-months follow-up visits from a serum sample using standardized kits
Time Frame
12 months
Title
Change in bone alkaline phosphatase
Description
It will be measured at baseline and 12-months follow-up visits from a serum sample using standardized kits
Time Frame
12 months
Title
Change in parathyroid hormone (PTH)
Description
It will be measured at baseline and 12-months follow-up visits from a serum sample using standardized kits
Time Frame
12 months
Title
Change in osteocalcin
Description
It will be measured at baseline and 12-months follow-up visits from a serum sample using standardized kits
Time Frame
12 months
Title
Change in bone specific alkaline phosphatase
Description
It will be measured at baseline and 12-months follow-up visits from a serum sample using standardized kits
Time Frame
12 months
Title
Change in serum creatinine
Description
It will be measured at baseline and 12-months follow-up visits from a serum sample using standardized kits
Time Frame
12 months
Title
Change in serum carboxy-terminal collagen crosslinks (CTX)
Description
I will be measured at baseline and 12-months follow-up visits using standardized kits
Time Frame
12 months
Title
Change in serum insulin growth factor 1 (IGF-I).
Description
It will be measured at baseline and 12-months follow-up visits from a serum sample using standardized kits
Time Frame
12 months
Title
Change in urinary calcium
Description
It will be measured at baseline and 12-months follow-up visits from a 24-h urine sample using standardized kits
Time Frame
12 months
Title
Change in urinary phosphorus
Description
It will be measured at baseline and 12-months follow-up visits from a 24-h urine sample using standardized kits
Time Frame
12 months
Title
Change in urinary creatinine
Description
It will be measured at baseline and 12-months follow-up visits from a 24-h urine sample using standardized kits
Time Frame
12 months
Title
Change in urinary N-telopeptide cross-links
Description
It will be measured at baseline and 12-months follow-up visits from a 24-h urine sample using standardized kits
Time Frame
12 months
Title
Change in total BMD
Description
Participants will undergo a bone scan at baseline, at 6 months and at 12-months follow-up visits using a dual energy x-ray absorptiometry (DXA)
Time Frame
12 months
Title
Change in spine BMC
Description
Participants will undergo a bone scan at baseline, at 6 months and at 12-months follow-up visits using a dual energy x-ray absorptiometry (DXA)
Time Frame
12 months
Title
Change in body fat
Description
Participants will undergo a bone scan at baseline, at 6 months and at 12-months follow-up visits using a dual energy x-ray absorptiometry (DXA)
Time Frame
12 months
Title
Change in phylogenetic diversity of bacterial communities
Description
Participants will provide a fecal sample at baseline and at 12-months follow-up visits using 16S ribosomal RNA (or 16S rRNA) gene sequences
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Body mass index between the 5th and 85th percentiles for age and sex based on the Centers for Disease Control Growth Charts. Exclusion Criteria: Subjects with any chronic illness requiring regular medication use. Those taking calcium supplements (>500 mg/d) and vitamin D supplements (>400 IU/d) on a regular basis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cristina Palacios, PhD
Phone
3053483235
Email
cristina.palacios@fiu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristina Palacios, PhD
Organizational Affiliation
Department of Dietetics, College of Public Health, Florida International Univ.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nicklaus Childrens Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jefry Biehler, MS
Email
jbiehle@fiu.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Investigators outside the research team will only be granted access to the data after their proposal has been evaluated and approved by the research team and by the Florida International University Office of Research Integrity. We will only provide access to the samples and de-identified data as required to address the proposed research goals and only under a data-sharing agreement.
IPD Sharing Time Frame
When the primary outcome is completed.
IPD Sharing Access Criteria
We will share the data and associated documentation only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.

Learn more about this trial

Effect of Soluble Corn Fiber Supplementation for 1 Year on Bone Metabolism in Adolescents

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