Trial Outcomes & Findings for Effect of Soluble Corn Fiber Supplementation for 1 Year on Bone Metabolism in Adolescents (NCT NCT02916862)
NCT ID: NCT02916862
Last Updated: 2025-11-10
Results Overview
Participants underwent a bone scan at baseline and after 12-months in the intervention using a dual energy x-ray absorptiometry (DXA)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
177 participants
Primary outcome timeframe
12 months
Results posted on
2025-11-10
Participant Flow
Although 213 were recruited (signed consent form), only 177 completed the randomization visit and were randomized.
Randomization was pre-determined using a block randomization document, which was computer generated.
Participant milestones
| Measure |
Placebo
This group received a similar supplement without SCF or calcium, administered twice a day
Placebo: Participants consumed a supplement without SCF or calcium carbonate for 12 months
|
Soluble Corn Fiber (SCF) + Calcium
This group received 12 g/d of soluble corn fiber (SCF) + 600 mg/d of elemental calcium carbonate, administered twice a day
Soluble Corn Fiber (SCF) + Calcium: Participants consumed a supplement with 12 g/day of SCF + calcium carbonate (600 mg/day) for 12 months
|
Soluble Corn Fiber (SCF) Without Calcium
This group received 12 g/d of soluble corn fiber (SCF) + 600 mg/d of elemental calcium carbonate, administered twice a day
Soluble Corn Fiber (SCF) without Calcium: Participants consumed a supplement with 12 g/day of SCF for 12 months
|
Placebo + Calcium
This group received a similar supplement without SCF + 600 mg/d of elemental calcium carbonate, administered twice a day
Placebo + calcium: Participants consumed a supplement without SCF + calcium carbonate (600 mg/day) for 12 months
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
43
|
45
|
43
|
46
|
|
Overall Study
COMPLETED
|
36
|
40
|
38
|
37
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
5
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Soluble Corn Fiber Supplementation for 1 Year on Bone Metabolism in Adolescents
Baseline characteristics by cohort
| Measure |
Soluble Corn Fiber (SCF) + Calcium
n=45 Participants
This group received 12 g/d of soluble corn fiber (SCF) + 600 mg/d of elemental calcium carbonate, administered twice a day
Soluble Corn Fiber (SCF) + Calcium: Participants consumed a supplement with 12 g/day of SCF + calcium carbonate (600 mg/day) for 12 months
|
Soluble Corn Fiber (SCF) Without Calcium
n=43 Participants
This group received 12 g/d of soluble corn fiber (SCF) + 600 mg/d of elemental calcium carbonate, administered twice a day
Soluble Corn Fiber (SCF) without Calcium: Participants consumed a supplement with 12 g/day of SCF for 12 months
|
Placebo
n=43 Participants
This group received a similar supplement without SCF or calcium, administered twice a day
Placebo: Participants consumed a supplement without SCF or calcium carbonate for 12 months
|
Placebo + Calcium
n=46 Participants
This group received a similar supplement without SCF + 600 mg/d of elemental calcium carbonate, administered twice a day
Placebo + calcium: Participants consumed a supplement without SCF + calcium carbonate (600 mg/day) for 12 months
|
Total
n=177 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
11.9 years
STANDARD_DEVIATION 1.35 • n=5 Participants
|
12.1 years
STANDARD_DEVIATION 1.51 • n=20 Participants
|
12.0 years
STANDARD_DEVIATION 1.23 • n=40 Participants
|
12.4 years
STANDARD_DEVIATION 1.4 • n=28 Participants
|
12.1 years
STANDARD_DEVIATION 1.51 • n=46 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
17 Participants
n=20 Participants
|
23 Participants
n=40 Participants
|
20 Participants
n=28 Participants
|
85 Participants
n=46 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
26 Participants
n=20 Participants
|
20 Participants
n=40 Participants
|
26 Participants
n=28 Participants
|
92 Participants
n=46 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
36 Participants
n=5 Participants
|
32 Participants
n=20 Participants
|
33 Participants
n=40 Participants
|
27 Participants
n=28 Participants
|
128 Participants
n=46 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
11 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
19 Participants
n=28 Participants
|
49 Participants
n=46 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=46 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=28 Participants
|
5 Participants
n=46 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
2 Participants
n=28 Participants
|
6 Participants
n=46 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=46 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
3 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
5 Participants
n=28 Participants
|
22 Participants
n=46 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
24 Participants
n=20 Participants
|
15 Participants
n=40 Participants
|
24 Participants
n=28 Participants
|
80 Participants
n=46 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
3 Participants
n=28 Participants
|
7 Participants
n=46 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=5 Participants
|
15 Participants
n=20 Participants
|
18 Participants
n=40 Participants
|
11 Participants
n=28 Participants
|
57 Participants
n=46 Participants
|
|
Tanner stage
|
2.73 score
STANDARD_DEVIATION 1.35 • n=5 Participants
|
2.57 score
STANDARD_DEVIATION 1.24 • n=20 Participants
|
2.74 score
STANDARD_DEVIATION 1.23 • n=40 Participants
|
2.76 score
STANDARD_DEVIATION 1.13 • n=28 Participants
|
2.70 score
STANDARD_DEVIATION 1.23 • n=46 Participants
|
|
Weight
|
46.8 kg
STANDARD_DEVIATION 11.5 • n=5 Participants
|
46.7 kg
STANDARD_DEVIATION 10.6 • n=20 Participants
|
44.6 kg
STANDARD_DEVIATION 12.4 • n=40 Participants
|
47.1 kg
STANDARD_DEVIATION 10.6 • n=28 Participants
|
46.3 kg
STANDARD_DEVIATION 11.2 • n=46 Participants
|
|
Height
|
151.8 cm
STANDARD_DEVIATION 10.8 • n=5 Participants
|
151.8 cm
STANDARD_DEVIATION 11.0 • n=20 Participants
|
149.1 cm
STANDARD_DEVIATION 11.1 • n=40 Participants
|
154.1 cm
STANDARD_DEVIATION 8.36 • n=28 Participants
|
151.7 cm
STANDARD_DEVIATION 10.4 • n=46 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: A total of 151 children completed the 12 months visit. Results are presented as change from baseline to the 12 months visit.
Participants underwent a bone scan at baseline and after 12-months in the intervention using a dual energy x-ray absorptiometry (DXA)
Outcome measures
| Measure |
Placebo
n=36 Participants
This group received a similar supplement without SCF or calcium, administered twice a day
Placebo: Participants consumed a supplement without SCF or calcium carbonate for 12 months
|
Placebo + Calcium
n=37 Participants
This group received a similar supplement without SCF + 600 mg/d of elemental calcium carbonate, administered twice a day
Placebo + calcium: Participants consumed a supplement without SCF + calcium carbonate (600 mg/day) for 12 months
|
Soluble Corn Fiber (SCF) Without Calcium
n=38 Participants
This group received 12 g/d of soluble corn fiber (SCF) + 600 mg/d of elemental calcium carbonate, administered twice a day
Soluble Corn Fiber (SCF) without Calcium: Participants consumed a supplement with 12 g/day of SCF for 12 months
|
Soluble Corn Fiber (SCF) + Calcium
n=40 Participants
This group received 12 g/d of soluble corn fiber (SCF) + 600 mg/d of elemental calcium carbonate, administered twice a day
Soluble Corn Fiber (SCF) + Calcium: Participants consumed a supplement with 12 g/day of SCF + calcium carbonate (600 mg/day) for 12 months
|
|---|---|---|---|---|
|
Change in Whole Body Bone Mineral Content (BMC)
|
17.3 grams
Standard Deviation 9.2
|
20.7 grams
Standard Deviation 10.6
|
18.6 grams
Standard Deviation 10.5
|
20.1 grams
Standard Deviation 11.8
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: A total of 151 children completed the 12 months visit, but data from 1 child in the placebo+calcium group for BMC lumbar spine was not included as the DXA machine gave an error and it was not resolved in time and the child did not come back. Results are presented as change from baseline to the 12 months visit.
Participants underwent a bone scan at baseline and after 12-months in the intervention using a dual energy x-ray absorptiometry (DXA)
Outcome measures
| Measure |
Placebo
n=36 Participants
This group received a similar supplement without SCF or calcium, administered twice a day
Placebo: Participants consumed a supplement without SCF or calcium carbonate for 12 months
|
Placebo + Calcium
n=36 Participants
This group received a similar supplement without SCF + 600 mg/d of elemental calcium carbonate, administered twice a day
Placebo + calcium: Participants consumed a supplement without SCF + calcium carbonate (600 mg/day) for 12 months
|
Soluble Corn Fiber (SCF) Without Calcium
n=38 Participants
This group received 12 g/d of soluble corn fiber (SCF) + 600 mg/d of elemental calcium carbonate, administered twice a day
Soluble Corn Fiber (SCF) without Calcium: Participants consumed a supplement with 12 g/day of SCF for 12 months
|
Soluble Corn Fiber (SCF) + Calcium
n=40 Participants
This group received 12 g/d of soluble corn fiber (SCF) + 600 mg/d of elemental calcium carbonate, administered twice a day
Soluble Corn Fiber (SCF) + Calcium: Participants consumed a supplement with 12 g/day of SCF + calcium carbonate (600 mg/day) for 12 months
|
|---|---|---|---|---|
|
Change in Spine BMC
|
22.4 grams
Standard Deviation 13.2
|
23.8 grams
Standard Deviation 16.1
|
18.7 grams
Standard Deviation 10.8
|
21.8 grams
Standard Deviation 14.5
|
Adverse Events
Soluble Corn Fiber (SCF) + Calcium
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Soluble Corn Fiber (SCF) Without Calcium
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo + Calcium
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Soluble Corn Fiber (SCF) + Calcium
n=45 participants at risk
This group received 12 g/d of soluble corn fiber (SCF) + 600 mg/d of elemental calcium carbonate, administered twice a day
Soluble Corn Fiber (SCF) + Calcium: Participants consumed a supplement with 12 g/day of SCF + calcium carbonate (600 mg/day) for 12 months
|
Soluble Corn Fiber (SCF) Without Calcium
n=43 participants at risk
This group received 12 g/d of soluble corn fiber (SCF) + 600 mg/d of elemental calcium carbonate, administered twice a day
Soluble Corn Fiber (SCF) without Calcium: Participants consumed a supplement with 12 g/day of SCF for 12 months
|
Placebo
n=43 participants at risk
This group received a similar supplement without SCF or calcium, administered twice a day
Placebo: Participants consumed a supplement without SCF or calcium carbonate for 12 months
|
Placebo + Calcium
n=46 participants at risk
This group received a similar supplement without SCF + 600 mg/d of elemental calcium carbonate, administered twice a day
Placebo + calcium: Participants consumed a supplement without SCF + calcium carbonate (600 mg/day) for 12 months
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal discomfort
|
2.2%
1/45 • Number of events 1 • 1 year
Serum calcium
|
0.00%
0/43 • 1 year
Serum calcium
|
0.00%
0/43 • 1 year
Serum calcium
|
0.00%
0/46 • 1 year
Serum calcium
|
|
Musculoskeletal and connective tissue disorders
Low bone mass
|
0.00%
0/45 • 1 year
Serum calcium
|
2.3%
1/43 • Number of events 1 • 1 year
Serum calcium
|
0.00%
0/43 • 1 year
Serum calcium
|
2.2%
1/46 • Number of events 1 • 1 year
Serum calcium
|
|
Blood and lymphatic system disorders
High serum calcium
|
4.4%
2/45 • Number of events 2 • 1 year
Serum calcium
|
0.00%
0/43 • 1 year
Serum calcium
|
0.00%
0/43 • 1 year
Serum calcium
|
4.3%
2/46 • Number of events 2 • 1 year
Serum calcium
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place