Soy, Bone and Health in College Females
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss, Osteoporosis |
| Therapuetic Areas: | Endocrinology, Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 19 |
| Updated: | 4/21/2016 |
| Start Date: | October 2005 |
| End Date: | March 2006 |
Influence of Soy on Bone Turnover and Body Composition in College Females
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).
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).
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.
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.
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.
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