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Soy, Bone and Health in College Females

This study has been completed.
Sponsor:
Information provided by:
University of Georgia
ClinicalTrials.gov Identifier:
NCT00244478
First received: October 25, 2005
Last updated: September 21, 2006
Last verified: September 2006
History of Changes
  Purpose

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: www.revivalsoy.com/physlabs/).


Condition Intervention
Osteoporosis
Obesity
 Behavioral: Soy Protein Dietary Supplement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Influence of Soy on Bone Turnover and Body Composition in College Females

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Georgia:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

Estimated Enrollment: 120
Study Start Date: October 2005
Estimated Study Completion Date: March 2006
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, NCAA 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.

  Eligibility

Ages Eligible for Study:   18 Years to 19 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00244478

Locations
United States, Georgia
The University of Georgia
Athens, Georgia, United States, 30602
Sponsors and Collaborators
University of Georgia
Investigators
Principal Investigator: Richard D Lewis The University of Georgia
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00244478     History of Changes
Other Study ID Numbers: 10-20-2005-FOCUS
Study First Received: October 25, 2005
Last Updated: September 21, 2006
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Obesity
Osteoporosis
Overnutrition
Nutrition Disorders
Overweight
 Body Weight
Signs and Symptoms
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 23, 2013