Soluble Corn Fiber Effect on Bone Resorption in Post Menopausal Women

The Effect of Soluble Corn Fiber (SCF) on Bone Resorption in Post-Menopausal Women Using 41Calcium Technology

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02416947

Enrollment

Registered

2015-04-15

Start date

2012-03-31

Completion date

2015-01-31

Last updated

2015-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis, Postmenopausal

Keywords

Soluble Corn Fiber, Osteoporosis, Bone Loss

Brief summary

This study is designed to study the dose response effect of continuous Soluble Corn Fiber (SCF) intake over a 50 day period on bone resorption in healthy post menopausal women using the 41Calcium methodology. To further understand the dose response effect of SCF bone biomarkers will be studied. Our hypothesis is that soluble corn fiber will reduce bone resorption in a dose dependent manner in comparison to placebo when estimated by urinary 41Calcium excretion as well as bone biomarkers of resorption.

Detailed description

Subjects will be dosed with 41Calcium , a long-lived radio isotope, which will become deposited in the skeleton after about 100 days. During this time subjects will collect 24 h urine monthly to monitor the decrease in 41Calcium urinary excretion. Subsequently, the baseline level of 41Calcium urinary excretion will be evaluated over a 50 day baseline period with 24 h urine collections every 10 days. Participants will then be randomized to one of three doses of soluble corn fiber (0,10,20 g/d) to be consumed in two equivalent doses per day for 50 days. Women will collect 24 h urine every 10 days. Each 50 day period will be followed by a 50 day washout period during which the subjects will continue to collect urine every 10 days.

Interventions

DIETARY_SUPPLEMENT0 g SCF

0 grams of SCF will be administered daily in two equal doses in the form of a muffin and a drink.

DIETARY_SUPPLEMENT10g SCF

10 grams of SCF will be administered daily in two equal doses in the form of a muffin and a drink.

DIETARY_SUPPLEMENT20g SCF

20 grams of SCF will be administered daily in two equal doses in the form of a muffin and a drink.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Yes

Inclusion criteria

* Women at least 4 years Postmenopausal

Exclusion criteria

* Medications affecting bone resorption

Design outcomes

Primary

Measure	Time frame	Description
Change in 41Ca/Ca ratio in five 24 h urine collections during intervention periods compared to urinary 41Ca/Ca ratios during non-intervention periods	24 h urine collections on days 10, 20, 30, 40, and 50 of each of three intervention periods and 4 non intervention periods	41Ca/Ca ratio will be determined by Accelerator Mass Spectrometry. A linear regression model including the data from the non-intervention ratios will determine the predicted 41Ca/Ca ratios over the course of the 350 day study. The percent change of 41Ca/Ca ratios in the 50 day intervention periods from the predicted values will determine the effect of the intervention.

Secondary

Measure	Time frame
Fasting serum bone specific alkaline phosphatase (BSAP), a biochemical bone formation marker	Fasting serum drawn at the end of each 50 day intervention period
Fasting serum osteocalcin (OC), a biochemical bone turnover marker	Fasting serum drawn at the end of each 50 day intervention period
Fasting urine N-terminal telopeptide, a biochemical bone resorption marker	Fasting urine collected at the end of each 50 day intervention period

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026