Clinical trial NCT02416947: Soluble Corn Fiber Effect on Bone Resorption in Post Menopausal Women
Official title: The Effect of Soluble Corn Fiber (SCF) on Bone Resorption in Post-Menopausal Women Using 41Calcium Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis, Postmenopausal
Keywords: Soluble Corn Fiber
Osteoporosis
Bone Loss
Lead sponsor: Purdue University
Sponsor class: OTHER
Collaborators: name: Tate & Lyle Health & Nutrition Sciences
First posted: 2015-04-15
Enrollment: 14
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Women at least 4 years Postmenopausal

Exclusion Criteria:

* Medications affecting bone resorption

Primary outcomes:
measure: Change in 41Ca/Ca ratio in five 24 h urine collections during intervention periods compared to urinary 41Ca/Ca ratios during non-intervention periods
timeFrame: 24 h urine collections on days 10, 20, 30, 40, and 50 of each of three intervention periods and 4 non intervention periods
Secondary outcomes:
measure: Fasting serum bone specific alkaline phosphatase (BSAP), a biochemical bone formation marker
timeFrame: Fasting serum drawn at the end of each 50 day intervention period
measure: Fasting serum osteocalcin (OC), a biochemical bone turnover marker
timeFrame: Fasting serum drawn at the end of each 50 day intervention period
measure: Fasting urine N-terminal telopeptide, a biochemical bone resorption marker
timeFrame: Fasting urine collected at the end of each 50 day intervention period
Other outcomes:
Locations:
Study officials:
affiliation: Purdue University
name: Connie M Weaver, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jakeman SA, Henry CN, Martin BR, McCabe GP, McCabe LD, Jackson GS, Peacock M, Weaver CM. Soluble corn fiber increases bone calcium retention in postmenopausal women in a dose-dependent manner: a randomized crossover trial. Am J Clin Nutr. 2016 Sep;104(3):837-43. doi: 10.3945/ajcn.116.132761. Epub 2016 Jul 27.