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

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ClinicalTrials.gov Identifier: NCT02916862
Recruitment Status : Not yet recruiting
First Posted : September 28, 2016
Last Update Posted : July 4, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Cristina Palacios, PhD, Florida International University

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 11-14 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.

Condition or disease Intervention/treatment Phase
Osteoporosis Dietary Supplement: Soluble Corn Fiber (SCF) without Calcium Combination Product: Soluble Corn Fiber (SCF) + Calcium Dietary Supplement: Placebo Combination Product: Placebo + calcium Phase 3

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 11-14 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 236 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Soluble Corn Fiber Supplementation for 1 Year on Bone Metabolism in Adolescents
Estimated Study Start Date : November 15, 2019
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Soluble Corn Fiber (SCF) + Calcium
This group will receive 12 g/d of soluble corn fiber (SCF) + 600 mg/d of elemental calcium carbonate, administered twice a day
Combination Product: Soluble Corn Fiber (SCF) + Calcium
Participants will consume a supplement with 12 g/day of SCF + calcium carbonate (600 mg/day) for 12 months

Active Comparator: Soluble Corn Fiber (SCF) without calcium
This group will receive 12 g/d of soluble corn fiber (SCF) + 600 mg/d of elemental calcium carbonate, administered twice a day
Dietary Supplement: Soluble Corn Fiber (SCF) without Calcium
Participants will consume a supplement with 12 g/day of SCF for 12 months

Placebo Comparator: Placebo
This group will receive a similar supplement without SCF or calcium, administered twice a day
Dietary Supplement: Placebo
Participants will consume a supplement without SCF or calcium carbonate for 12 months

Placebo Comparator: Placebo + calcium
This group will receive a similar supplement without SCF + 600 mg/d of elemental calcium carbonate, administered twice a day
Combination Product: Placebo + calcium
Participants will consume a supplement without SCF + calcium carbonate (600 mg/day) for 12 months




Primary Outcome Measures :
  1. Change in bone mineral content (BMC) [ Time Frame: 12 months ]
    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)

  2. Change in total bone mineral density (BMD)-z score [ Time Frame: 12 months ]
    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 :
  1. Change in vitamin D status [ Time Frame: 12 months ]
    Vitamin D status will be measured as serum 25(OH)D at baseline and 12-months follow-up visits using standard ELISA kits.

  2. Change in serum calcium [ Time Frame: 12 months ]
    Serum calcium will be measured at baseline and 12-months follow-up visits using standardized kits

  3. Change in serum phosphate [ Time Frame: 12 months ]
    It will be measured at baseline and 12-months follow-up visits from a serum sample using standardized kits

  4. Change in bone alkaline phosphatase [ Time Frame: 12 months ]
    It will be measured at baseline and 12-months follow-up visits from a serum sample using standardized kits

  5. Change in parathyroid hormone (PTH) [ Time Frame: 12 months ]
    It will be measured at baseline and 12-months follow-up visits from a serum sample using standardized kits

  6. Change in osteocalcin [ Time Frame: 12 months ]
    It will be measured at baseline and 12-months follow-up visits from a serum sample using standardized kits

  7. Change in bone specific alkaline phosphatase [ Time Frame: 12 months ]
    It will be measured at baseline and 12-months follow-up visits from a serum sample using standardized kits

  8. Change in serum creatinine [ Time Frame: 12 months ]
    It will be measured at baseline and 12-months follow-up visits from a serum sample using standardized kits

  9. Change in serum carboxy-terminal collagen crosslinks (CTX) [ Time Frame: 12 months ]
    I will be measured at baseline and 12-months follow-up visits using standardized kits

  10. Change in serum insulin growth factor 1 (IGF-I). [ Time Frame: 12 months ]
    It will be measured at baseline and 12-months follow-up visits from a serum sample using standardized kits

  11. Change in urinary calcium [ Time Frame: 12 months ]
    It will be measured at baseline and 12-months follow-up visits from a 24-h urine sample using standardized kits

  12. Change in urinary phosphorus [ Time Frame: 12 months ]
    It will be measured at baseline and 12-months follow-up visits from a 24-h urine sample using standardized kits

  13. Change in urinary creatinine [ Time Frame: 12 months ]
    It will be measured at baseline and 12-months follow-up visits from a 24-h urine sample using standardized kits

  14. Change in urinary N-telopeptide cross-links [ Time Frame: 12 months ]
    It will be measured at baseline and 12-months follow-up visits from a 24-h urine sample using standardized kits

  15. Change in total BMD [ Time Frame: 12 months ]
    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)

  16. Change in spine BMC [ Time Frame: 12 months ]
    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)

  17. Change in body fat [ Time Frame: 12 months ]
    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)

  18. Change in phylogenetic diversity of bacterial communities [ Time Frame: 12 months ]
    Participants will provide a fecal sample at baseline and at 12-months follow-up visits using 16S ribosomal RNA (or 16S rRNA) gene sequences



Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02916862


Contacts
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Contact: Cristina Palacios, PhD 3053483235 cristina.palacios@fiu.edu

Sponsors and Collaborators
Florida International University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Cristina Palacios, PhD Department of Dietetics, College of Public Health, Florida International Univ.

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Responsible Party: Cristina Palacios, PhD, Associate Professor, Florida International University
ClinicalTrials.gov Identifier: NCT02916862     History of Changes
Other Study ID Numbers: 107593
1R01HD098589-01 ( U.S. NIH Grant/Contract )
First Posted: September 28, 2016    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: When the primary outcome is completed.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cristina Palacios, PhD, Florida International University:
fiber
calcium absorption
bone mass
adolescents

Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium, Dietary
Calcium Carbonate
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents