Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00244478
Status:
COMPLETED
Last Update Posted:
2015-09-25
First Post:
2005-10-25
Brief Title:
Soy Bone and Health in College Females
Sponsor:
University of Georgia
Organization:
University of Georgia
Study Overview
Official Title:
Influence of Soy on Bone Turnover and Body Composition in College Females
Status:
COMPLETED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a 16-week intervention to determine the efficacy of an isoflavone-rich soy based meal supplement to improve bone health and prevent weight and fat gain in 18-19 year old college females The primary hypothesis is that participants who receive soy will have favorable changes in blood markers of bone and less weight and fat gain The soy is provided by Physicians Pharmaceuticals Inc Revival Doctor-formulated soy protein
Detailed Description:
The proposed study will be a 16-week randomized double-blind placebo-controlled trial designed to test whether a daily isoflavone-rich soy-based meal replacement Revival Soy shake promotes favorables changes in bone biomarkers and attenuates weight gain in female college students First-year college females were selected because of the potential for significant weight gain during their freshman year The study will have a parallel design with two groups the soy treatment group SOY n 60 and a casein-based control CON n 60 Exclusion criteria include significant weight loss or gain in the past 3 months vegetarians and heavy soy food consumers National Collegiate Athletic Association Division I athletes women with eating disorders present illnesses chronic disease and those taking medications or herbal supplements known to affect body weight body fat or bone Participants will be stratified based on BMI 180-249 25-299 300 and randomized to either SOY or CON groups
Female college freshmen enrolled at the University of Georgia will be recruited in the fall of 2005 The soy-based meal replacements will contain 20 g soy protein and 1612 mg isoflavones 220-240 kcal 31-36 g total carbohydrates 0-2 g dietary fiber 500 mg calcium and 20-25 g total fat per serving The control shake will have 20 g casein substituted for soy protein and will be otherwise identical to the soy shakes The shakes will be available in two flavors chocolate and vanilla
Female college freshmen enrolled at the University of Georgia will be recruited in the fall of 2005 The soy-based meal replacements will contain 20 g soy protein and 1612 mg isoflavones 220-240 kcal 31-36 g total carbohydrates 0-2 g dietary fiber 500 mg calcium and 20-25 g total fat per serving The control shake will have 20 g casein substituted for soy protein and will be otherwise identical to the soy shakes The shakes will be available in two flavors chocolate and vanilla
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None