NCT00244478

Soy, Bone and Health in College Females

Influence of Soy on Bone Turnover and Body Composition in College Females

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: University of Georgia · Academic / Other
• Sex: Female
• Age: 18 Years – 19 Years
• Healthy volunteers: Accepted

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 (18.0-24.9; 25-29.9; ≥30.0) 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 161.2 mg isoflavones, 220-240 kcal, 31-36 g total carbohydrates, 0-2 g dietary fiber, 500 mg calcium, and 2.0-2.5 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.

Conditions

• Osteoporosis
• Obesity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Soy Protein Dietary Supplement	The soy-based meal replacements will contain 20 g soy protein and 161.2 mg isoflavones, 220-240 kcal, 31-36 g total carbohydrates, 0-2 g dietary fiber, 500 mg calcium, and 2.0-2.5 g total fat per serving.
DIETARY_SUPPLEMENT	Placebo	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.

Timeline

• Start date: 2005-10-01
• Primary completion: 2006-03-01
• Completion: 2006-03-01
• First posted: 2005-10-26
• Last updated: 2015-09-25

Locations

1 site across 1 country: United States