Status:
COMPLETED
Long-term Nutritional Intervention Study to Determine How Protein Affects Calcium Metabolism
Lead Sponsor:
Yale University
Collaborating Sponsors:
United States Department of Agriculture (USDA)
Conditions:
Osteoporosis
Eligibility:
FEMALE
20-40 years
Phase:
PHASE1
Brief Summary
Osteoporosis is a major health problem in men and women in this country and the incidence of this disease is rising. We think that environmental factors such as nutrition may play a role in the increa...
Detailed Description
The protocol is composed of a 9.5-week study, consisting of a 3-week adjustment period followed by a 6.5-week experimental period. During the adjustment period, subjects consume a well-balanced lead-i...
Eligibility Criteria
Inclusion
- Healthy Asian or Caucasian women between the ages of 20-40 years.
Exclusion
- Diseases or medical conditions: gastrointestinal diseases, osteoporosis, diabetes, hypertension, liver disease, thyroid disorders, kidney disease, kidney stones, cancer, heart disease, eating disorders, obesity, hypogonadism , amenorrhea, oligomenorrhea, abnormal serum FSH or estradiol levels, birth control medication, or other hormone-altering medications, pregnancy.
- Lifestyle: smoking, excessive exercise (although moderate exercise is allowed), prescription medications known to influence vitamin D or calcium metabolism or gastric acid, excessive body weight change during the past 6 months, food allergies, unusual eating habits, or medically prescribed diets.
- Also excluded are prisoners and individuals who are cognitively impaired.
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00671944
Start Date
May 1 2003
End Date
April 1 2010
Last Update
March 31 2020
Active Locations (1)
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1
Yale New Haven Hospital Research Unit
New Haven, Connecticut, United States, 06510