CompletedPhase 1

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

United States11 participantsStarted 2003-05

Plain-language 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 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.

Who can participate

Age range20 Years – 40 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Healthy Asian or Caucasian women between the ages of 20-40 years. Exclusion Criteria: * 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.

What they're measuring

Calcium absorption and kinetics

Timeframe: Baseline, day 5 and week 6

Trial details

NCT IDNCT00671944

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-10

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