Soy, Bone and Health in College Females

NCT00244478 | Completed DMC

• 1 other identifier: 10-20-2005-FOCUS
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Osteoporosis; Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (2)

Soy Protein Dietary Supplement

EXPERIMENTAL

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: Soy Protein Dietary Supplement

Placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Interventions

Soy Protein Dietary Supplement 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.

Soy Protein Dietary Supplement

Placebo DIETARY_SUPPLEMENT

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 19 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Georgia: lead

Study Sites (1)

The University of Georgia

Athens, Georgia, 30602, United States

Location

MeSH Terms

Conditions

Osteoporosis; Obesity

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard D Lewis

  The University of Georgia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 25, 2005
• First Posted: October 26, 2005
• Study Start: October 1, 2005
• Primary Completion: March 1, 2006
• Study Completion: March 1, 2006
• Last Updated: September 25, 2015

Record last verified: 2015-09

Locations

US (1)