SCF Supplementation for Bone Health in Adolescents
Recruiting in Palo Alto (17 mi)
+1 other location
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Florida International University
Must not be taking: Calcium, Vitamin D
Disqualifiers: Chronic illness, others
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial excludes participants who have a chronic illness requiring regular medication use, so if you are on regular medications for a chronic condition, you would not be eligible to participate.
What data supports the effectiveness of the treatment Soluble Corn Fiber (SCF) for bone health in adolescents?
Research shows that Soluble Corn Fiber (SCF) can increase calcium absorption in adolescents, which is important for bone health. A study found that SCF increased calcium absorption efficiency in pubertal females, suggesting it may help improve bone mineral content and density.
12345Is soluble corn fiber (SCF) safe for human consumption?
Soluble corn fiber (SCF) is generally considered safe for human consumption, as studies have shown it to be well-tolerated in adolescents and associated with increased calcium absorption without adverse effects.
12456How does the treatment with Soluble Corn Fiber (SCF) and Calcium differ from other treatments for bone health in adolescents?
The treatment with Soluble Corn Fiber (SCF) and Calcium is unique because SCF is a prebiotic fiber that can enhance calcium absorption in adolescents, potentially improving bone health. Unlike traditional calcium supplements, SCF works by interacting with gut bacteria to increase calcium absorption, which may be beneficial for those with low dietary calcium intake.
12678Eligibility Criteria
This trial is for healthy adolescents aged 10-13 who fall within the 5th to 85th percentiles for body mass index according to CDC growth charts. It's not open to those regularly taking calcium supplements over 500 mg/day, vitamin D over 400 IU/day, or anyone with a chronic illness requiring regular medication.Inclusion Criteria
My BMI is within the healthy range for my age and sex according to CDC charts.
Exclusion Criteria
I regularly take more than 500 mg of calcium and more than 400 IU of vitamin D daily.
I take regular medication for a chronic illness.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive soluble corn fiber (SCF) supplementation for 1 year to assess its effects on bone metabolism
52 weeks
Baseline, 6 months, 12 months (in-person); 3 and 9 months (home visits)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests if adding Soluble Corn Fiber (SCF), alone or with calcium, affects bone metabolism in adolescents compared to a placebo. Participants are randomly assigned into four groups: SCF only, SCF plus calcium, placebo only, and placebo plus calcium; taken twice daily for one year.
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Soluble Corn Fiber (SCF) + CalciumExperimental Treatment1 Intervention
This group will receive 12 g/d of soluble corn fiber (SCF) + 600 mg/d of elemental calcium carbonate, administered twice a day
Group II: Soluble Corn Fiber (SCF) without calciumActive Control1 Intervention
This group will receive 12 g/d of soluble corn fiber (SCF) + 600 mg/d of elemental calcium carbonate, administered twice a day
Group III: PlaceboPlacebo Group1 Intervention
This group will receive a similar supplement without SCF or calcium, administered twice a day
Group IV: Placebo + calciumPlacebo Group1 Intervention
This group will receive a similar supplement without SCF + 600 mg/d of elemental calcium carbonate, administered twice a day
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Citrus Health NetworkMiami, FL
Nicklaus Childrens HospitalMiami, FL
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Who Is Running the Clinical Trial?
Florida International UniversityLead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Collaborator
References
Effect of soluble corn fiber supplementation for 1 year on bone metabolism in children, the MetA-bone trial: Rationale and design. [2021]Calcium intake is critical for adequate bone mineralization in adolescence, but it is usually inadequate in US adolescents. A strategy to maximize bone mineralization is to increase calcium absorption, which could be achieved by soluble corn fiber (SCF). There are no studies determining the long-term effects of SCF on bone mass in children.
Effect of soluble corn fibre and calcium supplementation on bone mineral content and bone mineral density in preadolescent Malaysian children-a double-blind randomised controlled trial (PREBONE-Kids Study). [2023]Soluble corn fibre (SCF) with calcium did not improve bone indices after 1 year in preadolescent children.
Young adolescents who respond to an inulin-type fructan substantially increase total absorbed calcium and daily calcium accretion to the skeleton. [2023]Calcium absorption and whole-body bone mineral content are greater in young adolescents who receive 8 g/d of Synergy, a mixture of inulin-type fructans (ITF), compared with those who received a maltodextrin control. Not all adolescents responded to this intervention, however. We evaluated 32 responders and 16 nonresponders to the calcium absorptive benefits of ITF. We found no differences in usual dietary calcium intakes. Responders who increased their calcium absorption by at least 3% after 8 wk of Synergy had a greater accretion of calcium to the skeleton over a year based on whole-body dual-energy x-ray absorptiometry data. The absorptive benefit to ITF use in responders is substantial and would be comparable to increasing daily calcium intake by at least 250 mg. Increased intake of ITF may be an important aspect of a multifaceted approach to enhancing peak bone mass.
Novel fibers increase bone calcium content and strength beyond efficiency of large intestine fermentation. [2017]Dietary fibers are thought to benefit bone health through increasing mineral absorption and retention following fermentation in the lower gut and solubilization of minerals. This study compared eight fibers to cellulose following a 12 week intervention for production of short-chain fatty acids (SCFA), calcium absorption, mineral retention and bone content, and bone density and strength in a weanling rat model. Benefits to bone were poorly to modestly related to SCFA production, calcium absorption, or mineral retention, but some parameters were better predicted by cecal content weight, suggesting other mechanisms may be important. Nevertheless, two resistant starches, a soluble fiber dextrin and Polydextrose, increased bone calcium content. Soluble corn fiber and soluble fiber dextrin had the greatest benefit to bone properties including whole body bone mineral content and density and greater volumetric bone mineral density, cortical thickness and area, and peak breaking strength of the distal femur.
Soluble Corn Fiber Increases Calcium Absorption Associated with Shifts in the Gut Microbiome: A Randomized Dose-Response Trial in Free-Living Pubertal Females. [2023]Soluble corn fiber (SCF; 12 g fiber/d) is shown to increase calcium absorption efficiency, associated with shifts in the gut microbiota in adolescent males and females who participated in a controlled feeding study.
Soluble maize fibre affects short-term calcium absorption in adolescent boys and girls: a randomised controlled trial using dual stable isotopic tracers. [2017]Soluble maize fibre (SCF) has been found to significantly improve bone mineral density and strength in growing rats compared with several other novel prebiotic fibres. The objective of the present study was to investigate the effect of SCF on Ca absorption and retention in pubertal children by studying the potential absorption mechanisms of the intestinal microbiota. A total of twenty-four adolescent boys and girls (12-15 years) participated in two 3-week metabolic balance studies testing 0 g/d SCF (control (CON) treatment) and 12 g/d SCF (SCF treatment) in a random order by inclusion in a low-Ca diet (600 mg/d). Fractional Ca absorption was measured at the end of the two intervention periods using a dual-stable isotope method. Diet composites and faecal and urine samples were collected daily and analysed for Ca content. Ca retention was calculated as dietary Ca intake minus Ca excretion in faeces and urine over the last 2 weeks. Microbial community composition in the faecal samples collected at the beginning and end of each session was determined by 454 pyrosequencing of the PCR-amplified 16S ribosomal RNA gene. Fractional Ca absorption was 12 % higher (41 mg/d) after the SCF treatment compared with that after the CON treatment (0·664 (sd 0·129) and 0·595 (sd 0·142), respectively; P= 0·02), but Ca retention was unaffected. The average proportion of bacteria of the phylum Bacteroidetes was significantly greater in the participants after the SCF treatment than after the CON treatment. These results suggest that moderate daily intake of SCF, a well-tolerated prebiotic fibre, increases short-term Ca absorption in adolescents consuming less than the recommended amounts of Ca.
The effects of a high calcium dairy food on bone health in pre-pubertal children in New Zealand. [2006]Childhood and adolescence is the period of most rapid skeletal growth in an individual's lifetime. A greater peak bone mass achieved in the first 2-3 decades of life, may protect against the risk of osteoporotic fracture in later life. The aim of this randomized, controlled study was to assess in pre-pubertal boys and girls (aged 8-10 years) the effect of 18 months of a calcium enriched, cocoa flavoured product on bone density, bone growth and bone size in New Zealand children. One hundred and fifty four pre-pubertal boys and girls (aged 8-10 years) were randomized to receive a high calcium dairy drink or a control drink reconstituted with water for 18 months. They were assessed at baseline and then every 6 months for the first 18 months, while they were having the supplement; they were then followed up 12 months after supplementation had finished. Bone mineral density and bone mineral content were assessed at the total body, hip and spine. Indicators of bone size (vertebral width and height) were also measured at the spine. Anthropometric data was collected, medical history questionnaires were administered (including the Tanner or pubertal stage questionnaire), dietary calcium intake was assessed with a calcium food frequency questionnaire and calcium supplement compliance was determined. There was no significant difference between the 2 groups for bone mineral density or bone mineral content at any time point. There was no difference in vertebral height or width at any stage of the study, indicating no additional influence on bone size at the lumbar vertebrae. There were no significant differences between height, weight, lean mass or fat mass at any time point. Both groups had higher habitual calcium intakes than recommended for this age group going into the study and throughout the study. In this 2(1/2) year study (18 months supplementation, 1 year follow-up) we did not observe a difference in bone mineral density in pre-pubertal children. This was probably due to their high habitual dietary calcium intake whereby minimal addition of calcium to the diet reached the threshold level where no further benefit was seen. There were no significant differences between the two groups in body composition. Growth and the mean height and weight remained between the 50th and 75th percentile for their age. We have shown calcium supplementation in children with high habitual dietary calcium intake appears not to have additional effects on bone mass. Calcium supplementation needs to be targeted in those children with low habitual dietary calcium intake.
Soluble corn fiber increases bone calcium retention in postmenopausal women in a dose-dependent manner: a randomized crossover trial. [2023]Dietary soluble corn fiber (SCF) significantly improves calcium absorption in adolescents and the bone strength and architecture in rodent models.