Long-term Nutritional Intervention Study to Determine How Protein Affects Calcium Metabolism

Completed · Phase 1

Conditions studied: Osteoporosis

In brief

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 increasing prevalence of osteoporosis. In particular, we think that a diet that is too low in protein may be contributing to bone loss. The primary purpose of this study is to compare the long-term impact of a low protein diet on measures of bone and calcium metabolism.

Key facts

Study ID

NCT00671944

Run by

Yale University

People needed

11

Starts

2003-05-01

Expected to finish

2010-04-01

Last updated by the study team

2020-03-31

Who can join

Age: 20 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Healthy Asian or Caucasian women between the ages of 20-40 years.

You may not qualify if…

• 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.

Where it is running

• Yale New Haven Hospital Research Unit — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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