Soy, Bone and Health in College Females

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00244478
• Other study ID #: 10-20-2005-FOCUS
• Status: Completed
• Phase: N/A
• First received: October 25, 2005
• Last updated: September 23, 2015
• Start date: October 2005
• Est. completion date: March 2006

Study information

• Verified date: September 2015
• Source: University of Georgia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 19 Years

Eligibility

Inclusion Criteria:

• 18-19 year old University of Georgia college females of all races/ethnicities.

Exclusion Criteria:

• significant weight loss or gain, currently dieting to lose weight, are planning to lose weight, diet or begin an exercise program, under the age of 18, pregnant or intending to become pregnant, vegetarians, heavy soy food consumers, Division I athletes, women with menstrual irregularities, eating disorders, present or chronic illness, and those taking medications known to affect bone, body weight or body fat.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity
• Osteoporosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	The University of Georgia	Athens	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
University of Georgia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone specific alkaline phosphatase, N-telopeptide, osteocalcin, pyridinoline, deoxypyridinoline, height, weight, waist circumference, fat mass, fat-free soft tissue mass and bone mass will be measured at baseline, 8- and 16-weeks.
Secondary	Leptin, adipose tissue vascular endothelial growth factors, angiopoietins, and cytokines will be measured in the serum at baseline, 8- and 16-weeks. The impact of soy on satiety and depression will be measured at baseline, 8- and 16-weeks.